Feasibility trial of intervention for acne

Not Applicable

Completed

• Conditions: Acne; Skin and Connective Tissue Diseases; Acne vulgaris

• Registration Number: ISRCTN78626638
• Lead Sponsor: niversity of Southampton

Brief Summary

2021 Results article in https://doi.org/10.2196/25918 (added 16/11/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-07
• Study Completion: 2020-03-01
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Current acne vulgaris
2. Aged 14 to 25
3. Have had prescriptions for the treatment of acne within the last 6 months
4. Have access to the internet and an active email address
5. Able to read/understand English without assistance
6. People who are invited into the study may be using other medications (including oral antibiotics that still require topicals as well as people on isotretinoin) but people who have cleared up their acne will not be eligible to take part which will rule out anyone who is on isotretinoin for severe acne

Exclusion Criteria

1. Under 14 or over 25 years of age
2. Have taken part in the study to develop the internet intervention
3. Have severe mental health problems
4. Their acne has cleared up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The primary outcomes from this feasibility trial will be as follows:<br> 1. Number of practices required to recruit the participant numbers and the rate of recruitment<br> 2. Number of participants withdrawing from the intervention and the trial at 4 weeks and follow-up retention rates at 6 weeks<br> 3. With regard to the behavioural intervention, the extent of participant’s usage of the website will be measured<br> 4. Participant adherence to the behavioural intervention will be explored by examining intervention usage data, which will provide detailed information on number of logins, module accessed as well as time spent on each webpage (automatically collected on LifeGuide software)<br> 5. The acceptability of measuring skin specific quality of life using the Skindex-16 instrument at baseline, 4 and 6 weeks, as a potential primary outcome for the main trial<br>

Secondary Outcome Measures

Name	Time	Method
<br> The feasibility of a range of quantitative measures:<br> 1. Demographic questions including age and gender measured at baseline<br> 2. Health state measured using the EQ-5D-5L at baseline, 4 and 6 weeks<br> 3. Perceived reasons for non-adherence to treatment measured using the Problematic Experiences of Therapy Scale (PETS) at baseline, 4 and 6 weeks<br> 4. Belief about treatment and its likely success measured using the credibility/expectancy questionnaire at baseline, 4 and 6 weeks<br> 5. Anxiety and depression measured using the patient health questionnaire (PHQ-4) at baseline, 4 and 6 weeks<br> 6. Topical use and other treatments used measured at baseline, 4 and 6 weeks<br>