Atopic dermatitis Skin and Connective Tissue Diseases
Conditions
Interventions
The study subjects were randomly allocated to study arm based on a computer-generated sequence with 1:1 ratio: Dermasectan or Placebo. The subjects received for 14 consecutive days two applications/da
Sponsors
Novintethical Pharma (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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; 3. Patient chart assessment by PATIENT ORIENTED ECZEMA MEASURE (POEM)– recorded at visits from: day 0, day 8, day 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Bulgaria, Romania
Outcome results
None listed