Atopic Dermatitis
Conditions
Keywords
Eczema, Dermatitis, Skin Diseases, Skin Diseases, Genetic, Dermatitis, Atopic, Skin Diseases, Eczematous, Hypersensitivity, Immune System Diseases
Brief summary
The objective of the study is to evaluate the safety and efficacy of DMT210 Gel, 5% compared to vehicle control following 28 days of twice-daily topical application to selected target lesions in male and female patients with mild to moderate atopic dermatitis (AD).
Interventions
DRUGDMT210 Topical Gel
DMT210 Topical Aqueous Gel 5% applied twice daily
DRUGVehicle Control
Topical Vehicle Gel applied twice daily
Sponsors
Dermata Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female 12 years or older * Patient has chronic, stable AD that has been present for at least 3 months with 5-35% (inclusive) BSA (Body Surface Area) of AD involvement * Patient has two analogous, Target Lesions; one lesion within each of the two Treatment Areas * Patient is willing and able to comply with the protocol
Exclusion criteria
* Patient has used topical therapies for AD within the Treatment Areas 2 weeks before baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADSI (Atopic Dermatitis Severity Index) score of each Target lesion | Day 28 | Change from baseline in ADSI score between Vehicle and 5% gel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion | Day 28 | Change from baseline in AD symptom scores between Vehicle and 5% gel |
| Investigator Global Assessment (IGA) of the Treatment Area | Day 28 | — |
Other
| Measure | Time frame |
|---|---|
| Incidence of adverse events as a measure of safety and tolerability | Day 28 |
Countries
United States
Outcome results
None listed