DMT210 Topical Gel in the Treatment of Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: DMT210 Topical Gel; Drug: Vehicle Control

• Registration Number: NCT02949960
• Lead Sponsor: Dermata Therapeutics

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Primary Completion: 2017-07-14
• Study Completion: 2017-07-14
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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Exclusion Criteria

• Patient has used topical therapies for AD within the Treatment Areas 2 weeks before baseline

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DMT210 Topical Gel	DMT210 Topical Gel	DMT210 Topical Gel 5% applied to target lesion twice daily
Vehicle Control	Vehicle Control	Topical Gel vehicle applied to target lesion twice daily

Primary Outcome Measures

Name	Time	Method
ADSI (Atopic Dermatitis Severity Index) score of each Target lesion	Day 28	Change from baseline in ADSI score between Vehicle and 5% gel

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dermata Investigational Site; 🇺🇸 Norfolk, Virginia, United States