Skip to main content
OpenTrials
Completed

NCT Number: NCT02949960

DMT210 Topical Gel in the Treatment of Atopic Dermatitis

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermata Investigational Site, Houston, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DMT210 Topical Gel

Drug

DMT210 Topical Aqueous Gel 5% applied twice daily

vehicle control

Drug

Topical Vehicle Gel applied twice daily

Primary outcomes

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

    Time frame: Day 28

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

Secondary outcomes

  1. Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion

    Time frame: Day 28

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

  2. Investigator Global Assessment (IGA) of the Treatment Area

    Time frame: Day 28

Other outcomes

  1. Incidence of adverse events as a measure of safety and tolerability

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Dermata Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2016
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.