Evaluation of Dermasectan® versus SoC to compare efficacy and safety in treating atopic eczema (dermatitis) in adults
- Conditions
- Atopic dermatitisSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN66879853
- Lead Sponsor
- ovintethical Pharma (Switzerland)
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37560506/ (added 11/08/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 42
1. Adult subjects, 18 years or older
2. Subject willing to sign the informed consent
3. AD diagnosed at screening visit
4. Clinical digital photography to provide images of affected and healthy skin
5. Willing and able to comply with all clinic visits and study-related criteria
1. The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment:
1.1 Systemic corticosteroids
1.2 Immunosuppressive/immunomodulating drugs
1.3 Phototherapy for AD
2. Treatment with certain biologics
3. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit
4. Planned major surgical procedure during the patient's participation in this study
5. Patient is a member of the investigational team or his/her immediate family
6. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study
7. Hypersensitivity to any of the ingredients of the study agents.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Erythema, pruritus, exudation, excoriation, crusted erosions and lichenification are measured using a 4-point (0-3) scale - Atopic Dermatitis Severity Index (ADSI) - recorded at visits from: day 0, day 8, day 15.<br>2. Redness, swelling, oozing/crusting, scratch marks, skin thickening (lichenification), dryness are measured using SCORAD (Score Atopic Dermatitis) Calculator at the doctor’s office at the time of the visits at day 0, day 8, day 15;<br>3. Patient chart assessment by PATIENT ORIENTED ECZEMA MEASURE (POEM)– recorded at visits from: day 0, day 8, day 15.
- Secondary Outcome Measures
Name Time Method The safety outcomes (percentage of participants who experienced an AE, number of drop-out due to side effects, disease progression) were evaluated during study visit at Day 8, Day 15 and Day 28.