A study to evaluate Adex Gel in the treatment of atopic eczema.
Research type
Research Study
Full title
A study to evaluate the performance of Adex Gel in the treatment of atopic eczema using SCORAD and Quality of Life Assessments
IRAS ID
316640
Contact name
Samir Purnell-Mullick
Contact email
Sponsor organisation
Dermal Laboratories
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary: This is a clinical evaluation of an already marketed, CE-marked medical device used in accordance with its certified intended purpose. As such, the study forms part of the manufacturer's post market surveillance obligations for purposes of confirming the product's ongoing safety and performance in accordance with Part B Annex XIV of Medical Device Regulation EU/2017/745.
The aim of this study is to evaluate the performance of Adex Gel using SCORAD and CDLQI in children with moderate atopic eczema. Study patients will be asked to use Adex Gel three times daily, for 4 weeks instead of their usual emollient or as the first treatment for their condition, and not to use any corticosteroids or immunomodulators. The SCORAD assessment will be performed by the investigator/ research nurse at baseline and then after 2 and 4 weeks of treatment. Patients or their parents/ guardians will be asked to complete the quality-of-life questionnaires (Children's Dermatology Life Quality Index (CDLQI) at baseline and after 4 weeks of treatment. Photographs of one eczema affected area will also be taken at baseline and again 4 weeks after treatment.
Summary of Results:
A study to look at the performance of Adex Gel on moderate eczema in children.
• This was a study performed in the UK in GP surgeries.
• Patients used Adex Gel 3 times a day for 28 days.
• The study assessments were SCORAD (SCORing Atopic Dermatitis). It assesses redness, dryness, swelling, and other eczema symptoms. Patients also filled out a questionnaire, the Children's Dermatology Life Quality Index (CDLQI and the Cartoon CDLQI) about their quality of life before and after using Adex Gel.
• Patients showed a significant improvement in both SCORAD and quality of life after 4 weeks of using Adex Gel.
• None of the side effects reported by patients in the study were serious or unexpected.
• This study showed that Adex Gel is very effective in improving eczema symptoms and quality of life for children with moderate eczema.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
22/WM/0175
Date of REC Opinion
28 Sep 2022
REC opinion
Further Information Favourable Opinion