Acne care online
| ISRCTN | ISRCTN65493744 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65493744 |
| IRAS number | 330774 |
| Secondary identifying numbers | CPMS 57037, NIHR202852, IRAS 330774 |
- Submission date
- 13/02/2024
- Registration date
- 20/02/2024
- Last edited
- 20/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Acne is very common, frequently causes distress or low self-confidence, and may lead to permanent scarring, long-lasting dark marks, or depression. Treatment of acne is a major cause of antibiotic use amongst young people, leading to antibiotic resistance. Evidence and guidelines suggest that topical treatments (creams or gels applied directly to the skin) should be the main treatments for acne. Effective topical treatments are available from pharmacies without a prescription, but many people are unaware of these and buy cosmetic products that don’t help instead. People often give up on topical treatments because they are not given full advice on how to use them. For example, they don’t know how to reduce the risk of stinging and redness or that it takes several weeks for treatments to start working.
We have developed a new website to help young people with acne to manage acne more effectively, including information on how to obtain effective treatments, promote regular treatment use and advice on how to avoid side effects.
We will test the new website in a randomised trial: first of all to check that the website and the study procedures work as expected and are acceptable and accessible for the people who take part; and after this to see whether it improves outcomes for people with acne and reduces the use of long-term oral antibiotics.
Who can participate?
People with acne (aged 13-25 years) will be invited to take part in the study through a variety of sources including from GP practices, pharmacies, community and social media advertising, and through schools and other partner organisations.
What does the study involve?
Participants will be asked to register online and complete an online consent form and questionnaire before being allocated by chance (randomly) to either the new study website, or to the control group. All participants will be able to access their usual health care or acne treatments during the study. Participants will be asked to complete questionnaires at 12, 24, 36 and 52 weeks (1 year) asking about their acne, quality of life and their use of acne treatments.
Participants in the control group will be signposted to standard NHS advice about acne. They will also be offered access to the new website at the end of the study period. We will also explore how the new website works and what its like for people taking part in the study, by talking to those that have taken part and analysing how they used the website.
What are the possible benefits and risks or participating?
Participants will get access (either immediately or at the end of the study) to a brand new website with advice and support about managing acne. Once they complete the study, they will also be entered into a prize draw to win one of 4 x £50 vouchers.
Participation will take up a small amount of participants time in answering online questionnaires (about 10-15 mins each time they are completed)
Where is the study run from?
University of Southampton (UK)
When is the study starting and how long is it expected to run for?
April 2023 to November 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Julie Hooper, Trial Manager, acnecare@soton.ac.uk
Contact information
Scientific
Primary Care Research Centre, University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
 ORCID ID |
0000-0002-2702-6951 |
|---|---|
| Phone | +44 2380 590742 |
| acnecare@soton.ac.uk |
Principal Investigator
Primary Care Research Centre, University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| ORCID ID |
0000-0001-7264-5260 |
|---|---|
| Phone | +44 2380 590742 |
| acnecare@soton.ac.uk |
Public
Primary Care Research Centre, University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| ORCID ID |
0000-0001-6580-6150 |
|---|---|
| Phone | +44 2380 590742 |
| acnecare@soton.ac.uk |
Study information
| Study design | Feasibility randomized controlled trial with nested mixed-methods process evaluation becoming full scale effectiveness and cost-effectiveness trial with nested mixed-methods process evaluation. Feasibility trial will become internal pilot to full scale trial if no substantial changes to the intervention or trial processes are required (as determined by analysis of the feasibility trial and process evaluation data) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Internet/virtual |
| Study type | Other, Quality of life, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Acne Care Online (ACO): feasibility and full scale randomised controlled trials of a digital behaviour change intervention to improve acne-related quality of life amongst 13-25 year olds |
| Study acronym | ACO |
| Study hypothesis | Feasibility trial objectives: 1. To determine the feasibility of an online behavioural intervention aimed at supporting self-management, improving outcomes and reducing antibiotic use in acne. The study also aims to test the trial processes and procedures to determine whether any changes are needed prior to the subsequent full scale trial. 2. Should no changes be required, the feasibility trial will become an internal-pilot for the full scale trial Full scale trial objectives: 1. To evaluate the clinical effectiveness of the Acne Care Online self-management intervention for acne in improving acne outcomes 2. To explore mechanisms underlying effectiveness of the intervention through process evaluation 3. To undertake an economic evaluation to estimate cost-effectiveness of the intervention compared with usual care from NHS and patient perspectives |
| Ethics approval(s) |
Approved 22/11/2023, North West - Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 207 104 8290; gmeast.rec@hra.nhs.uk), ref: 23/NW/0323 |
| Condition | Acne vulgaris |
| Intervention | In both the feasibility and full scale trials, recruited participants will be randomised using the LifeGuide software hosting the digital intervention into one of two groups: Intervention arm (immediate access to Acne Care Online): 1. Sign-up, consent, screening, baseline measures and randomisation (all completed online) – approx. 15-20 mins 2. Use of Acne Care Online – duration completed self-determined by participant – participant is able to use as much or as little as preferred within the 12 month study period 3. Follow-up measures at 4 subsequent time points: 12 weeks, 24 weeks, 36 weeks and 52 weeks – approx. 10-15 mins each time Usual care arm (Access to standard care, sign-posting to NHS Acne advice, access to Acne Care Online after 12 month study period): 1. Sign-up, consent, screening, baseline measures and randomisation (all completed online) – approx. 15-20 mins 2. Access NHS Acne advice (optional) – duration self-determined by participant 3. Follow-up measures at 4 subsequent time points: 12 weeks, 24 weeks, 36 weeks and 52 weeks – approx. 10-15 mins each time Randomisation will be completed by the LifeGuide software that will be hosting Acne Care Online. Acne Care Online is a digital behaviour change intervention including advice, support and interactive tools to support effective self-management of acne. |
| Intervention type | Behavioural |
| Primary outcome measure | Acne severity measured using the Acne-QoL symptoms subscale at 12 weeks, compared with baseline |
| Secondary outcome measures | 1. Acne severity evaluated over 12 months using Acne-QoL symptom subscale, using repeated measures analysis over 12 weeks, 24 weeks, 36 weeks and 52 weeks, controlled for baseline 2. Acne-QoL other subscales (self-perception, role-emotional and role-social) and total score evaluated over 12 months using Acne-QoL symptom subscale using repeated measures analysis over 12 weeks, 24 weeks, 36 weeks and 52 weeks, controlled for baseline 3. Use of topical treatment for acne at baseline, 12 weeks, 24 weeks, 36 weeks and 52 weeks (self-report and treatment adherence) 4. Use of acne-related antibiotics and other oral acne treatment use at baseline, 12 weeks, 24 weeks, 36 weeks and 52 weeks, including frequency of use (self-report) 5. Past use of topical and oral treatments for acne 6. Problematic Experiences of Therapy Scale (PETS) will be asked prior to adherence questions at baseline,12 weeks and 52 weeks. 7. Patient Enablement Instrument (PEI) at baseline, 12 weeks and 52 weeks 8. Brief Illness Perceptions Questionnaire (BIPQ) at baseline, 12 weeks and 52 weeks 9. Patient Health Questionnaire (PHQ–4) for Anxiety and Depression at baseline, 12 weeks and 52 weeks 10. EQ-5D-5L at baseline, 12 weeks, 24 weeks, 36 weeks and 52 weeks 11. Short Warwick Edinburgh Mental Well-being Scale (SWEMWBS) at baseline, 12 weeks, 24 weeks, 36 weeks and 52 weeks 12. Resource use will be measured at baseline, 12 weeks, 24 weeks, 36 weeks and 52 weeks (self-report) 13. 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 14. Demographics 15. Age of onset and duration of acne Part of the objective of the feasibility trial is to assess questionnaire burden and if this is not acceptable to participants we will consider not including the Brief IPQ and SWEMWBS in the full scale trial |
| Overall study start date | 01/04/2023 |
| Overall study end date | 30/11/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 13 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 968 total: Feasibility trial n = 60 (up to 20 in qualitative process evaluation); Full-scale trial = 908 (20-25 in qualitative process evaluation) |
| Participant inclusion criteria | 1. Aged 13-25 years with self-defined acne with current active lesions (i.e. mild or worse on self-assessment scale) 2. Have internet access For primary care recruitment GPs will invite potential participants via database searches that will identify patients aged 13 to 25 years who either: 1. Have been prescribed a topical treatment for acne or co-cyprindiol in the previous 12 months or 2. Have a diagnostic code for acne on their electronic record over the previous 12 months either with or without having been prescribed an oral tetracycline or erythromycin in that period. |
| Participant exclusion criteria | 1. Their acne is currently clear or almost clear, i.e. if they answer ‘no’ to the following question asked online at baseline screening: “Do you have spots or acne on your face at the moment? This could include whiteheads or more red spots or bumps.” 2. They are unable to give informed consent or their parent does not provide consent (for participants aged 13-15 recruited via community or social media advertising) 3. They are unable to read and write English as the intervention content and outcome measures are in English 4. They are 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 5. They took part in interviews as part of Acne Care Online intervention development. (Qualitative interviewees who did not view intervention materials will NOT be excluded) 6. Only one person per household will be able to take part in the study. If someone from that household has already joined the study then they will be excluded from the study 7. If the feasibility trial remains separate to the full scale trial, participants in the feasibility trial will be excluded from the full-scale trial |
| Recruitment start date | 15/07/2024 |
| Recruitment end date | 31/10/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Southampton
SO17 1BJ
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Calmore
Southampton
SO40 2RZ
United Kingdom
Sponsor information
University/education
University Road
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44 2380 595058 |
|---|---|
| rgoinfo@soton.ac.uk | |
| Website | http://www.southampton.ac.uk/ |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We will publish this work in peer-reviewed journals, at conferences and via patient organisations. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Miriam Santer, Chief Investigator, (acnecare@soton.ac.uk). The type of data that will be shared: 1) potentially any non-identifiable quantitative data dependent on reasonable request; 2) non-identifiable qualitative data dependent on reasonable request, only where participants have consented to this use of their interview data. When the data will become available and for how long: after all publications of study findings is complete. By what access criteria data will be shared including with whom: upon reasonable request to/discussion with the chief investigator Consent item for participation in the trial (quantitative data): “anonymised data may be used for future research, clinical purposes, study materials or for teaching. These organisations may be universities or NHS organisations in this country or abroad.” For participation in qualitative process interviews (qualitative data), the equivalent consent item is optional so only qualitative data from participants who provided consent for this item would potentially be shared comments on data anonymisation, only anonymised data will be shared any ethical or legal restrictions, As above, the researchers will share anonymised data for further research if participants have consented to this, upon reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3 | 04/02/2025 | 20/03/2025 | No | No |
Additional files
Editorial Notes
20/03/2025: Protocol uploaded. The target number of participants was changed from '648 total: Feasibility trial n = 60 (up to 20 in qualitative process evaluation); Full scale trial = 588 (20-25 in qualitative process evaluation)' to '968 total: Feasibility trial n = 60 (up to 20 in qualitative process evaluation); Full-scale trial = 908 (20-25 in qualitative process evaluation)'.
08/07/2024: The recruitment start date was changed from 01/07/2024 to 15/07/2024.
15/05/2024: The recruitment start date was changed from 20/05/2024 to 01/07/2024.
12/04/2024: The recruitment start date was changed from 15/04/2024 to 20/05/2024.
12/03/2024: The recruitment start date was changed from 04/03/2024 to 15/04/2024. IPD sharing plan added.
13/02/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
