DMT210 Topical Gel in the Treatment of Atopic Dermatitis

April 17, 2018 updated by: Dermata Therapeutics

DMT210 Topical Gel in the Treatment of Mild to Moderate 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77056
        • Dermata Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Dermata Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DMT210 Topical Gel
DMT210 Topical Gel 5% applied to target lesion twice daily
Drug: DMT210 Topical Gel
DMT210 Topical Aqueous Gel 5% applied twice daily
PLACEBO_COMPARATOR: Vehicle Control
Topical Gel vehicle applied to target lesion twice daily
Drug: Vehicle Control
Topical Vehicle Gel applied twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 28
Investigator Global Assessment (IGA) of the Treatment Area
Time Frame: Day 28
Day 28

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events as a measure of safety and tolerability
Time Frame: Day 28
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dermata Therapeutics

Investigators

  • Study Director: Christopher Nardo, PhD, Dermata Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ACTUAL)

July 14, 2017

Study Completion (ACTUAL)

July 14, 2017

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (ESTIMATE)

October 31, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMT210-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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