NCT05454722Completed
A Study to Evaluate Adex Gel in the Treatment of Atopic Eczema.
A Study to Evaluate the Performance of Adex Gel in the Treatment of Atopic Eczema Using SCORAD and Quality of Life Assessments.
Source: ClinicalTrials.gov · Last updated 17 May 2024
Brief summary (registry, in English)
This is a prospective, open label, uncontrolled study which will be performed in multiple Primary Care (GP) centres, in approximately 60 children (aged 1 year to 15 years) who have moderate atopic eczema and who are not currently using oral or topical corticosteroids or immunomodulators and have not used them in the previous month. 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 without supplementary use of any oral or topical steroids or immunomodulators (unless this becomes unavoidable, see section 4.6.3). The Scoring Atopic Dermatitis (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, which will not include any identifiable features or details of the patient, of one eczema affected area will also be taken at baseline and again 4 weeks after treatment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 7 Jul 2022
- Start date
- 16 Nov 2022
- Primary completion date
- 28 Mar 2024
- Lead sponsor
- Dermal Laboratories Ltd
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05454722
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 16 Nov 2022 to the primary completion date, 28 Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are currently using or have used in the past month, any oral or topically applied corticosteroids, Adex Gel or immunomodulators for their atopic eczema.
- Participating in other ongoing studies or have participated in a study in the previous 30 days.
Other illness
- Have a known history of intolerance or skin sensitivity to any of the ingredients of Adex Gel (as identified on the patient information sheet and product labelling), or similar products.
- Have severe or potentially infected eczema.
- Patients with any medical condition which, in the opinion of the Investigator, may adversely influence their participation in the study.
Age
- Under 1 year of age or over 15 years and 11 months at screening.
Other
- Have mild eczema.
- Patients, or their parents/ legal guardians, who may have difficulties completing the quality-of-life questionnaire, which will be written in English only.
- Employees of the Sponsor or Investigators, or any immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of such employees.
Who the study is looking for
- Male or female.
- Aged between 1 year and 15 years.
- Patients with atopic eczema (personal or combined personal and familial atopy), of moderate severity in accordance with the NICE categorisation
- SCORAD assessment score of between 25 to 50.
- Minimum score of 6 on the CDLQI (QoL).
- Patients or their parents/ legal guardians must be able to read and understand the patient information sheet and sign the consent form.
- Patients normally managing their eczema by regular and ongoing use of leave-on emollient(s), or new atopic eczema sufferers, who have not been using oral or topical corticosteroids, Adex Gel or immunomodulators for the last month.
- Patients who are willing to use only Adex Gel for 4 weeks.
- Patients who are willing to continue to use their standard wash regime for the duration of the study. This will be documented at the initial visit.
Age in the registry: 1 year to 15 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atherstone Surgery Coordinator of this site? Confirm its status | Atherstone | United Kingdom | Unknown status |
| Cripps Health Centre Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.