DMT210 Topical Gel in the Treatment of Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

DMT210 Topical Gel in the Treatment of Mild to Moderate Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949960
• Other study ID #: DMT210-002
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2016
• Last updated: April 17, 2018
• Start date: October 2016
• Est. completion date: July 14, 2017

Study information

• Verified date: April 2018
• Source: Dermata Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 14, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• DMT210 Topical Gel
DMT210 Topical Aqueous Gel 5% applied twice daily
• Vehicle Control
Topical Vehicle Gel applied twice daily

Locations

Country	Name	City	State
United States	Dermata Investigational Site	Houston	Texas
United States	Dermata Investigational Site	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Dermata Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events as a measure of safety and tolerability		Day 28
Primary	ADSI (Atopic Dermatitis Severity Index) score of each Target lesion	Change from baseline in ADSI score between Vehicle and 5% gel	Day 28
Secondary	Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion	Change from baseline in AD symptom scores between Vehicle and 5% gel	Day 28
Secondary	Investigator Global Assessment (IGA) of the Treatment Area		Day 28