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acne, primary care, randomized trial, young people, treatment adherence, behavioural intervention
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Santer M, Becque T, Essery R et al. Acne Care Online: protocol for a randomised trial of a digital behaviour change intervention to improve acne-related quality of life amongst 13-25 year olds [version 1; peer review: awaiting peer review]. NIHR Open Res 2026, 6:91 (https://doi.org/10.3310/nihropenres.14302.1)
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Study Protocol
Acne Care Online: protocol for a randomised trial of a digital behaviour change intervention to improve acne-related quality of life amongst 13-25 year olds
[version 1; peer review: awaiting peer review]
PUBLISHED 16 Jul 2026
OPEN PEER REVIEW
REVIEWER STATUS
Abstract
Plain Language Summary
Corresponding author:
Miriam Santer
Competing interests:
No competing interests were disclosed.
Grant information:
This study is funded by the NIHR Programme Grant for Applied Research (NIHR 202852). Matthew Ridd is funded by an NIHR Research Professorship (NIHR 303123). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:
© 2026 Santer M et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Santer M, Becque T, Essery R et al. Acne Care Online: protocol for a randomised trial of a digital behaviour change intervention to improve acne-related quality of life amongst 13-25 year olds [version 1; peer review: awaiting peer review]. NIHR Open Res 2026, 6:91 (https://doi.org/10.3310/nihropenres.14302.1)
First published: 16 Jul 2026, 6:91 (https://doi.org/10.3310/nihropenres.14302.1)
Latest published: 16 Jul 2026, 6:91 (https://doi.org/10.3310/nihropenres.14302.1)
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Introduction
Acne vulgaris (hereon acne) is extremely common, affecting over 90% of teenagers, and commonly persists into adulthood.1 Acne can cause decreased self-confidence, increased rates of depression and suicidal ideation.2 Acne is thought to cause scarring in approximately 20% of the population.2,3 As well as limiting quality of life, acne is a major cause of antibiotic use, with one study demonstrating that long-term prescribing of antibiotics commonly used for acne account for 72% of total antibiotic days amongst people aged 11 to 21 years.4 Antibiotic resistance arising from acne treatment is an increasing concern with use of effective alternatives to antibiotics being a major priority.5 Health service use for acne is substantial with 3% of people aged 13–25 visiting their GP for acne each year,6 of whom 8% are referred to secondary care.6
Topical treatments for acne are the first-line treatments for mild-to-moderate acne in the UK and according to international guidelines.7,8 Although some contain antibiotics, there are effective topicals that do not include antibiotics.9 People with acne often have little awareness of effective topical treatments available via pharmacy or on prescription and instead use ineffective cosmetic products.10 They frequently consult late, and at a point when they are disillusioned with topical treatments and are keen for oral treatments, commonly antibiotics, which are incorrectly perceived as being more effective.10 When topical treatments are used, adherence is low, mainly because young people find it difficult to maintain regular use over several weeks, while seeing little benefit initially, and commonly experience skin irritation unless mitigating advice is emphasised and followed.11
Online interventions can change health-related behaviours when based on robust development,12 and can improve outcomes in long-term conditions.13 Given the barriers to treatment (low awareness of effective topical treatments, low adherence and insufficient management of side effects), there have been many calls for improved education and information for people with acne.2,11,14 However, there is little research evaluating behavioural interventions for acne to date: the most recent review identified four RCTs of interventions; two used emails or text messaging (both small and inconclusive) and two used increased follow-up visits.15
We developed Acne Care Online, a digital (online) behaviour change intervention including advice, support and interactive tools to help people self-manage acne effectively, including by promoting appropriate treatment use: intervention development paper and intervention checklist previously published.16 Intervention content was based on qualitative data10 and systematic reviews17 and followed the person-based approach to intervention development.16
This paper reports how we aim to evaluate the clinical outcomes and cost-effectiveness of the intervention by conducting a randomised controlled trial (RCT) with nested mixed-methods process evaluation.
Methods
Patient and public involvement
Public partners have been involved at all stages in seeking funding, designing, conducting, and planning reporting of the trial and will be involved in dissemination. The research question arose through talking to people with lived experience of acne and asking what would have helped them at the time. Irene Soulsby is a permanent member of the Programme Management Group. Original public partner Kate Henaghan-Sykes is now a staff member as a PPIE manager and remains on the Programme Management Group. An additional public partner on the Programme Management Group recently took up other commitments and a new public partner has joined. Public partners on the Programme Management Group have been involved at all stages, including shaping public-facing documents, promoting the use of social media for recruitment and driving greater diversity in public involvement (see below). Irene Soulsby and Kate Henaghan-Sykes are co-authors on this publication.
A ‘virtual acne patient panel’ of 24 young people invited through a variety of sources provided input on multiple aspects of trial design, including designing recruitment resources and selection and refinement of outcome measures and resource use questions. All public partners including the virtual panel were also involved at every stage of designing the intervention for testing. A related project is further enhancing the intervention through in-depth public involvement support from young people with diverse skin tones.
Design
We designed a multicentre pragmatic, parallel group, unmasked, 1:1 randomised superiority trial to:
• Evaluate clinical effectiveness of online self-management intervention for acne in improving acne outcomes
• Explore mechanisms underlying effectiveness of the intervention through mixed methods process evaluation
• Undertake a within trial economic evaluation to estimate the cost-effectiveness of the intervention compared with usual care from NHS and patient perspectives
The protocol is reported in line with SPIRIT reporting guidelines,18 and registered with ISRCTN65493744 https://doi.org/10.1186/ISRCTN65493744. The SPIRIT checklist is available at https://doi.org/10.5258/SOTON/D3941.
We planned a feasibility RCT that would become an internal pilot to the full-scale trial if no substantial changes to the intervention or trial processes were required (as determined by analysis of the feasibility trial and process evaluation data). As no substantial changes were needed, the feasibility trial became an internal pilot, with all data included to maximise research efficiency.
The internal pilot phase comprised the first 85 participants and was assessed according to progression criteria (recruitment exceeds 70% of predicted). Therefore, no substantial changes to recruitment were needed19 and the internal pilot was rolled into a full-scale trial following a discussion with the Programme Management Group and Programme Steering Committee.
Trial setting and recruitment of participants
Young people with acne will be recruited through a variety of settings across England: general practices, pharmacies, community and social media advertising, and schools and colleges.
In general practice, invitations are sent through SMS text and/or postal mail out or poster advertising (16–25 s only). The original mail out strategy was based on database searches that identified patients aged 13 to 25 years who either (1) had been prescribed a treatment for acne in the previous 12 months and/or (2) had a diagnostic code for acne in their electronic record over the previous 12 months. For patients aged 13 to 15 years postal invitations are sent to parent/carer and the invitation is only sent via SMS text if the practice is aware that the phone number belongs to a parent/carer rather than the young person. The invitation is framed as raising awareness of the study, rather than stating that the young person had consulted to protect confidentiality.
Following monitoring of participant characteristics within the first six months, we found that many were already using topical treatments, and we hoped for a broader sample, including people who were not yet using topical treatments. Given the very high prevalence of acne in the teenage and young adult population, following a protocol amendment, practices began sending invitations to all people aged 16 to 25 registered at participating practices to offer study participation to young people with acne who have not yet consulted.
In community pharmacies, potential participants, or their parent/carer if under 16, are given a summary participant information sheet by the pharmacy professional directing them to the study website. The study website includes a full participant information sheet, who to contact for further information or discussion, information on eligibility, and how to proceed to provide online consent prior to participating in the study activities.
Through schools/colleges, parents/carers of potential participants will be invited via SMS text or email from the school or college, directing interested individuals to the study website.
Community or social media advertising will be targeted only at potential participants aged 16 or over in order to ensure the ability to provide consent (see the section on consent below). Social media advertisements direct potential participants towards the study website, which includes full participant information, as mentioned above.
All trial procedures (consent, randomisation, completion of outcome measures) will be carried out online.
Eligibility criteria
We focus on young people aged 13–25 years with self-defined mild and moderate acne with current active lesions (i.e., mild or worse on self-assessment scale) and who have internet access. This is the group most likely to benefit. Acne in people over the age of 25 years and those with severe acne can be more difficult to manage.
Exclusion criteria:
• Acne is currently clear or almost clear, i.e. indicate 0 or 1on the Patient Global Assessment of Acne on baseline screening questionnaire20
• Unable to give informed consent or their parent/carer does not provide consent (for participants aged 13–15 recruited via community or social media advertising)
• Unable to read and write English (as the intervention content and outcome measures are in English)
• Currently taking oral isotretinoin or have taken it within the previous 3 months (as advice about topical acne treatments may be inappropriate in this case)
• Took part in interviews as part of Acne Care Online intervention development (qualitative interviewees who did not view intervention materials are not excluded)
• Only one person per household will be able to take part in the study
Randomisation and masking
Recruited participants will be randomised in a 1:1 ratio using LifeGuide software.21 Randomisation is carried out in blocks of 4 and 6 and stratified by gender, age (13 to 15 years vs. 16 to 25 years), and recruitment source (general practice vs. social media/pharmacy/schools/colleges/community recruitment).
Masking is not possible for trial participants, as they will be aware whether they have been allocated to use Acne Care Online or NHS acne webpages. Trial statisticians will remain masked to treatment allocation until the primary analysis has been performed. It will not be possible for all members of the study team to remain masked, particularly those carrying out process evaluation interviews and those assisting in identifying participants for these interviews.
Intervention and comparator
Participants randomised to the intervention group receive immediate access to Acne Care Online: participants can use as much or as little as they choose within the 12-month study period. Acne Care Online is a digital (online) behaviour change intervention that includes advice, support, and interactive tools to help people self-manage acne effectively, including promoting appropriate treatment use.16 To encourage continued engagement/prompt participants to revisit, brief SMS/email ‘tips’ will be shared with participants at 3 days post randomisation, then once weekly until 6 weeks, and two-weekly thereafter until 12 weeks. These messages promote specific features of the intervention and encourage people to return to access them providing a direct link to log back in.
Participants randomised to the comparator group will be signposted to standard NHS advice on acne (online)22: participants can use this as much or as little as they choose. The use of signposting to NHS advice on acne was chosen for the comparator group, as this is likely to be where people in the UK would currently seek evidence-based advice, although it is acknowledged that the source of information for acne varies widely, with many seeking advice via social media or other sources.23
Both groups can access usual care throughout the study period, including consulting health professionals, getting/taking prescriptions or over-the-counter medications, and accessing any online information that they wish to use. Both groups will have access to Acne Care Online after they have completed their 12-month study period.
Outcomes (See Table 1: schedule of observations to show timings of measurements)
Table 1. Participant timeline: Schedule of interventions, and assessments.40
The primary outcome is acne severity measured using the Acne-QoL symptoms subscale at 12 weeks. Acne-QoL is the most extensively validated acne outcome measure.24–26 There is not yet a core outcome set developed for acne, although the Acne-QoL is compatible with current developments.27,28
Secondary outcomes:
• Acne severity evaluated over 12 months using Acne-QoL symptoms subscale, using repeated measures over 12, 24, 36, and 52 weeks
• Acne-QoL other subscales (self-perception, role-emotional, and role-social) and total score evaluated over 12 months using Acne-QoL symptoms subscale using repeated measures over 12, 24, 36, and 52 weeks
• Use of topical treatment for acne at baseline, 12, 24, 36, and 52 weeks (self-report and treatment adherence)
• Use of acne-related antibiotics and other oral acne treatment use at baseline, 12, 24, 36, and 52 weeks, including frequency of use (self-report)
Other measures for process evaluation, economic evaluation and sample description:
• Past use of topical and oral treatments for acne
• Problematic Experiences of Therapy Scale (PETS)29 will be asked prior to adherence questions at baseline,12 weeks and 52 weeks (PETS asks to what extent participants have been prevented from carrying out the intervention by socially acceptable reasons to explore barriers to adherence and promote reporting of non-adherence (e.g. “Lack of time prevented me from carrying out the treatment”)
• The Patient Enablement Instrument (PEI)30 at baseline, 12 and 52 weeks to assess the extent to which usual care or intervention use has enabled participants to understand and self-manage their acne
• The Brief Illness Perceptions Questionnaire (BIPQ)31 at baseline, 12 weeks and 52 weeks to explore participants’ beliefs about their acne, which are expected to be an important determinant of adherence
• Patient Health Questionnaire (PHQ–4)32 for Anxiety and Depression at baseline, 12 weeks and 52 weeks
• EQ-5D-5L33 at baseline and at 12, 24, 36, and 52 weeks
• Short Warwick Edinburgh Mental Well-being Scale (SWEMWBS)34 at baseline, 12, 24, 36, and 52 weeks
• Resource use will be measured at baseline, 12, 24, 36, and 52 weeks (self-report)
• Prior belief in effectiveness of online interventions will be asked at baseline and use and type of online resources previously used for acne will be asked at baseline, 12 weeks and 52 weeks
• Demographics: age, gender, ethnicity, postcode, occupation or parental occupation
• Age of onset and duration of acne
Engagement with the intervention is also collected to inform the process evaluation. Minimum meaningful engagement is defined as participants proceeding at least one page beyond the tailored ‘dashboard’ landing page. Any page beyond this point contained content which made it possible for participants to have engaged with key intervention messages.
Harms are unlikely, as no specific therapeutic intervention is proposed, only allocation to two different sources of online information to support acne self-management. Therefore, we did not formally collect data on adverse events. Serious adverse events may be reported by study participants when completing resource use questions; if these are judged to be related to using the intervention, they will be reported to the Programme Steering Committee, Sponsor, HRA, and included in study outputs.
Data collection methods and retention
Participants will directly enter data into the intervention website (built using LifeGuide software21). Retention of participants is promoted through automated email, text/SMS reminders and phone calls. Email/SMS reminders (up to three at each follow-up time point) each contain a direct link to the Acne Care Online login page and encouragement to complete outcome measures. For some participants where multiple reminders have not led them to complete online data, their primary outcome data will be collected by telephone. This is recorded and stored electronically then data is entered into a SPSS database, with data entry double-checked. Data collected by telephone will be merged with Lifeguide output data when data collection is completed, with self-reported (LifeGuide) data prioritised in the case of any discrepancy.
Sample size
Our original sample size calculation was based on a comparison of the Acne-QoL symptoms subscale at 12 weeks, power 90%, alpha 0.05 and seeking a standardised effect size of 0.30 (standard deviation 5.8). This gave a target sample of 470 participants or a total of 588 participants, allowing for a 20% loss to follow-up. An effect size of 0.30 equates to a difference in Acne-QoL symptoms subscale between arms of 1.74 points, meaning we would be conservatively powered to detect the published minimal clinically reported difference for Acne-QoL, which is a difference of 2 points on the symptom subscale.25,26 A standard deviation 5.8 aligns with trials with a similar patient group.26
While monitoring adherence to the intervention, we found lower than anticipated engagement and therefore submitted an ethics amendment to increase our sample size. Based on a comparison of the Acne-QoL symptoms subscale at 12 weeks, power 90%, alpha 0.05, mean difference 2 points and standard deviation 5.8, 356 participants are needed. Allowing for 30% nonadherence would require 356/0.7^2 = 727, allowing for a 20% loss to follow-up would require 908 participants in total.
Statistical methods
Data will be reported and presented according to the revised CONSORT (Consolidated Standards of Reporting Trials) Statement. The main estimand of interest will be the treatment policy estimand and the intention-to-treat population will include all randomised participants according to randomised group. For our primary outcome, we will use a linear regression model to analyse Acne-QoL symptoms subscale at 12 weeks, adjusting for baseline Acne-QoL symptoms subscale and stratification factors (gender, age and recruitment route). A 95% confidence interval for the mean difference between randomised groups will be reported. The primary outcome will be analysed using multiple imputation with chained equations, assuming that the data are missing at random (MAR). The imputation model will include all variables in the analysis model and auxiliary variables that predict missingness of the outcome. We will include sensitivity analyses using delta-based multiple imputation to explore the impact of data missing not at random (MNAR), and also a complete case analysis. A sensitivity analysis will also be carried out, including a random effect for recruitment source (general practice or social media/pharmacy/schools/colleges/community recruitment).
As a secondary analysis, we assess the Acne-QoL symptoms subscale and other Acne-QoL subscales (self-perception, role-emotional and role-social) with a repeated measures analysis using a multilevel mixed model allowing for observations (level 1) at all time points (12, 24, 36, and 52 weeks) nested within participants (level 2) and adjusting for the same covariates as the primary analysis. We will also conduct a secondary analysis examining the Acne-QoL symptoms subscale outcome measure among participants who met minimal engagement with the website (Complier Average Causal Effect analysis).
Other secondary outcomes will be modelled using a regression modelling approach with a distribution appropriate to the outcome: linear regression for continuous outcomes, logistic regression for binary outcomes, and a suitable count distribution, such as Poisson or negative binomial, for count data. Any subgroup analyses will be planned and pre-specified in the statistical analysis plan. No interim analyses are planned.
Health economic evaluation
The economic evaluation aims include:
• Describing the types of resource used for acne within the study sample.
• Estimate mean resource use and costs in people with acne in the intervention group compared to the usual care group.
• Estimate mean Quality-Adjusted Life Years (QALYs)/Mental Wellbeing-Adjusted Life Years (mWALYs) in people living with acne in both groups.
• Undertake an incremental cost-utility analysis to inform decision-making regarding whether online intervention should be promoted for acne care in the NHS.
A within-trial economic evaluation will estimate whether the online intervention is cost-effective compared to usual care from an NHS and personal social services perspective, and separately from a participant/family perspective, as appropriate. We will estimate cost of the intervention and wider health care costs. Data on intervention resource use will be collected by the trial team, while wider health resource use, in particular acne-related prescriptions, service use, out-of-pocket costs, and productivity costs incurred by participants (or their families) will be collected through online questionnaires at baseline, 12, 24, 36, and 52 weeks.
We measure two outcomes for use in the economic evaluation: the EQ-5D-5L, which has published evidence supporting its use in acne,35–37 and the Short Warwick Edinburgh Mental Well-being Scale (SWEMWBS).34 The latter is included on the basis that four of the five dimensions on the EQ-5D measure physical health and so SWEMWBS may be more applicable, if mental well-being is more important than physical components when valuing outcomes for acne. The EQ-5D-5L will be valued in line with NICE recommendations at the time of analysis and the SWEMWBS will be valued using a UK preference-based value set that has been published enabling the estimation of Mental Well-being Adjusted Life Years (MWALY).34
The amount and pattern of missing data will be explored to inform the analysis. It is not uncommon for economic data to face higher levels of missingness compared to clinical data in trials. Where appropriate, an incremental cost utility analysis will be performed using seemingly unrelated regression analysis (if assumptions hold) to estimate the incremental cost-effectiveness ratio and/or net monetary benefit of the online intervention compared to usual care alone for both incremental cost per QALY and MWALY. Should levels of missing data be substantial, such that analytical methods of dealing with missing data are unlikely to produce estimates that are reliable or unbiased, the economic data will be presented as a cost-consequence analysis that does not combine costs and outcomes in an incremental analysis instead.38,39 Sensitivity analyses will be undertaken to explore key uncertainties in the analysis. A Health Economics Analysis Plan (HEAP) will be written and reviewed before the trial database is locked.
Nested process evaluation
A mixed-methods process evaluation study aims to:
• Understand how participants engage with, and experience, the trial and intervention
• Understand factors that mediate and moderate outcomes for participants
• Provide further contextual understanding of the trial outcomes
Self-reported quantitative measures will allow exploration of key anticipated behavioural determinants in the quantitative process evaluation: beliefs about acne and acne treatments, perceptions of self-efficacy, outcome expectations, psychosocial impact of acne, adherence to treatments, perceived barriers to this, and treatment/advice-seeking behaviours. The specific measures and time-points are shown in the ‘Schedule of Observations and Procedures’. Objective measures of intervention use automatically recorded in LifeGuide software, with participant consent, will allow evaluations of intervention usage patterns, such as time spent on intervention, number of visits to the intervention website and pages/sections visited.
Qualitative process data will be collected from a sub-sample of participants, aiming to interview approximately 20 people in the intervention group and approximately 10 people in the control group. We will try to achieve a maximum variation sample of included participants with regards to characteristics such as age, gender, ethnicity, acne duration and perceived severity, and level of usage of the online intervention (for the intervention group).
Data from the qualitative process study will be analysed, first, using reflexive thematic analysis to construct themes grounded in the data. We will triangulate findings from the quantitative and qualitative process analyses to explore and test the potential causal mechanisms proposed, to help inform interpretation of trial results, determine how the intervention could be improved and how implementation into clinical practice could be facilitated.
Monitoring trial conduct
This is a low-risk trial, so monitoring of recruitment, data quality, protocol adherence, and any study-related adverse events are coordinated through the study management team in Southampton, and oversight is maintained by the Programme Management Group, consisting of a study management team and co-applicants including public partners.
The Programme Steering Committee acts as the oversight body on behalf of the Sponsor and Funder. The Acne Care Online Programme Steering Committee (PSC) will be the Trial Steering Committee for this RCT. The PSC meets at least yearly and consists of four independent members, including the Chair, plus a representative of funder and sponsor. One of the four independent members is a public contributor with experience of acne.
The duties of a Data Monitoring Committee, to safeguard the interests of study participants, monitor the main outcome measures including safety and efficacy, and monitor the overall conduct of the study, will also be carried out by the Acne Care Online Programme Steering Committee. The Acne Care Online PSC charter defines the membership, terms of reference, roles, responsibilities, authority, decision-making and relationships of the PSC, including the timing, frequency, and format of meetings.
The trial sponsor (University of Southampton) and funder (NIHR) have not been involved in the design or conduct of the study, although they provide oversight through the Programme Steering Committee. They will not be involved in the analysis and reporting of trial.
Ethics
The trial protocol was approved by the North West - Greater Manchester East Research Ethics Committee reference 23/NW/0323 on 23 November 2023.
Amendments were not implemented until approval had been received from study sponsor and ethics committee. Non-substantial amendments included minor corrections to wording of recruitment materials. The only substantial amendment (protocol amendment) was Amendment 4: sample size increase and revised primary care invitation strategy. Research Ethics Committee approval for this amendment was received on 10 March 2025.
Consent
Consent procedures are aimed at striking a balance between enabling young people to take part in research, as young people are currently underserved in acne research, versus ensuring informed age-appropriate consent to participate in research. Age-appropriate recruitment materials explain what is involved for potential participants and have been carefully developed with public partners.
Participants aged 16 or over complete informed consent online (e-consent) through study software only after they have received full study details and study team contact information, to allow time for consideration and the opportunity to ask questions.
For potential participants aged 13 to 15 years, the initial invitation is sent to their parent/carer, either through their registered practice or their school. Their parent/carer is then provided with an information sheet or link to the study website where they can review this information. If they choose to pass this invitation on to the young person this means that ‘implied consent’ has been given by the parent/carer, meaning that a young person under the age of 16 would not receive materials inviting them to participate in the study unless their parent/carer chooses to pass on this information. The young person then has access to the study website where they can review study details, study team contact information, participant information sheet, and opportunity to request further information/have questions answered, prior to being asked to complete online informed consent (e-consent) through the study software.
In previous studies, where the parent/carer has been required to provide documented consent and contact details for the young person, there has been a very high drop-off in the number of people engaging with the study. It is unknown whether this is because young people are not interested in the study, or whether they are uninterested in research presented to them by their parent/carer, but the result is under-representation of under-16 s in research. Including this process of ‘implied consent’ from parents/carers promotes accessibility to research participation for young people. This is particularly appropriate for a low-risk study where all trial procedures are online and the decision to be randomised only relates to the choice between new online information and standard NHS information.
For process evaluation interviews, separate informed consent is sought, and for participants aged 13–15, online consent from the parent/carer will be obtained prior to seeking and recording verbal consent (assent) from the young person prior to the start of the interview.
Data confidentiality
The confidentiality of all participants taking part in the study will be preserved. The study team will ensure that participants’ anonymity is maintained and that their identities are protected from unauthorised parties. Participant data will be collected online via LifeGuide software and stored securely on servers hosted by the University of Southampton. The participant data is pseudo anonymised by assigning each participant a participant identification number that will be adapted for use in LifeGuide. For qualitative interviews, all electronic data will be stored on a secure server until the transcriptions have been completed. Once these have been carried out and unique identifiers have been assigned then the digital audio recordings will be destroyed.
Data sharing
The datasets generated and/or analysed during the current study will be available upon email request from the chief investigator (m.santer@soton.ac.uk) after publication of the study findings. The type of data that will be shared: 1) potentially any non-identifiable quantitative data dependent on reasonable request; and 2) non-identifiable qualitative data dependent on reasonable request, only where participants have consented to this use of their interview data. Data has not been published in a repository as the ethics committee approval, including approved consent form, did not include a statement permitting data sharing.
Reporting guidelines
Figshare: SPIRIT checklist for ‘[SPIRIT checklist - acne care online: protocol for a randomised trial of a digital behaviour change intervention]’. http://dx.doi.org/10.5258/SOTON/D3941.41
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
Dissemination
We will share the study findings with public partners, participants, health professionals involved in the study, and other interested parties. We will publish our findings in peer-reviewed journals, conferences and update trial registry. We will share a plain English summary and video summary via a diverse range of patient organisations and social media platforms. If effective, we will aim to make the new website freely available and ensure widespread uptake by working with public partners, young people and health professionals to signpost and endorse its use.
Ethics and registration
Enrolment 15/07/2024 to 08/10/2025. Follow-up will be complete October 2026.
Protocol v3 [4 February 2025] available: Acne Care Online|Primary Care Research Centre|University of Southampton.
Registration: ISRCTN65493744 https://doi.org/10.1186/ISRCTN65493744
Funder: NIHR202852.
Sponsor: University of Southampton, University Road, Southampton SO17 1BJ. Sponsor’s reference 86407.
Ethical approval granted by Greater Manchester East Research Ethics Committee ref: 23/NW/0323 on 22 Nov 2023.
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Santer M, Becque T, Essery R et al. Acne Care Online: protocol for a randomised trial of a digital behaviour change intervention to improve acne-related quality of life amongst 13-25 year olds [version 1; peer review: awaiting peer review]. NIHR Open Res 2026, 6:91 (https://doi.org/10.3310/nihropenres.14302.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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