DMT210 Topical Gel in the Treatment of Atopic Dermatitis

Dermata Therapeutics

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Vehicle Control; Drug: DMT210 Topical Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02949960

DMT210-002

Details and patient eligibility

About

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).

Enrollment: 19 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups, including a placebo group

DMT210 Topical Gel

Experimental group

Description:

DMT210 Topical Gel 5% applied to target lesion twice daily

Treatment:

Drug: DMT210 Topical Gel

Vehicle Control

Placebo Comparator group

Description:

Topical Gel vehicle applied to target lesion twice daily

Treatment:

Drug: Vehicle Control