DMT210 Topical Gel in the Treatment of Acne Rosacea

April 17, 2018 updated by: Dermata Therapeutics

A Randomized, Double-Blind, Vehicle Controlled Study To Evaluate The Safety, Tolerability, And Efficacy Of DMT210 Gel In Adult Patients With Moderate To Severe Acne Rosacea

The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

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
    • California
      • San Diego, California, United States
        • Dermata Investigational Site
    • Florida
      • Miami, Florida, United States
        • Dermata Investigational Site
    • Minnesota
      • Fridley, Minnesota, United States
        • Dermata Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Dermata Investigational Site
    • North Carolina
      • High Point, North Carolina, United States
        • Dermata Investigational Site
    • Pennsylvania
      • Broomall, Pennsylvania, United States
        • Dermata Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Dermata Investigational Site
    • Texas
      • Austin, Texas, United States
        • Dermata Investigational Site
    • Virginia
      • Norfolk, Virginia, United States
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is male or non-pregnant female at least 18 years of age.
  • Clinical diagnosis of moderate to severe facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization
  • Patient has at least ten inflammatory lesions of rosacea on the face at Randomization
  • Patient is willing to apply the Investigational Product as directed
  • Patient is willing and able to comply with the protocol

Exclusion Criteria:

  • Patient is pregnant or planning to become pregnant
  • Patient is taking a topical therapy which may affect the patient's rosacea

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DMT210 Topical Gel
DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks
Drug: DMT210 Topical Gel 5%
Placebo Comparator: Vehicle Control
Topical Gel vehicle applied to the face twice daily for 12 weeks
Other: Vehicle Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy as measured by Inflammatory lesion counts
Time Frame: 12 weeks
Inflammatory lesion counts
12 weeks
Efficacy as measured by Investigator Global Assessment (IGA)
Time Frame: 12 weeks
Investigator Global Assessment (IGA)
12 weeks
Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)
Time Frame: 12 weeks
5-point Clinical Erythema Assessment (CEA)
12 weeks
Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)
Time Frame: 12 weeks
5-point Patient Severity Assessment of Erythema (PSA)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events as a measure of safety and tolerability
Time Frame: 12 weeks
Incidence of adverse events as a measure of safety and tolerability
12 weeks

Collaborators and Investigators

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

Sponsor

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

January 1, 2017

Primary Completion (Actual)

August 30, 2017

Study Completion (Actual)

August 30, 2017

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 21, 2016

First Posted (Estimate)

December 26, 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

  • DMT210-003

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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