DMT210 Topical Gel in the Treatment of Atopic Dermatitis

Dermata Therapeutics19 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

DMT210 Topical GelDRUG

DMT210 Topical Aqueous Gel 5% applied twice daily

Vehicle ControlDRUG

Topical Vehicle Gel applied twice daily

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (2)

Dermata Investigational Site

Houston, Texas, United States

Dermata Investigational Site

Norfolk, Virginia, United States

Outcomes

Primary Outcomes

ADSI (Atopic Dermatitis Severity Index) score of each Target lesion

Change from baseline in ADSI score between Vehicle and 5% gel

Time frame: Day 28

Secondary Outcomes

Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion

Change from baseline in AD symptom scores between Vehicle and 5% gel

Time frame: Day 28

Investigator Global Assessment (IGA) of the Treatment Area

Time frame: Day 28

Data from ClinicalTrials.gov

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