DMT310-005 Topical in the Treatment of Acne Rosacea

December 7, 2022 updated by: Dermata Therapeutics

A Study Of The Tolerability, Safety, And Efficacy Of DMT310 For The Treatment Of Acne Rosacea

The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne rosacea.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

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
      • Austin, Texas, United States, 78759
        • 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 papulopustular acne rosacea as determined by:

Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory lesions on the face

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 on the face 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Treatment 1
DMT310 Powder mixed with Hydrogen Peroxide
Drug: Topical Powder
Topical Powder mixed with diluent
Experimental: Study Treatment 2
Placebo powder mixed with Hydrogen Peroxide
Drug: Placebo Topical Powder
Placebo Topical Powder mixed with diluent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy as measured by lesion counts
Time Frame: 12 Weeks
Inflammatory lesion counts
12 Weeks
Efficacy as measured by Investigator Global Assessment (IGA)
Time Frame: 12 Weeks

IGA Scale:

0 Clear No papules and/or pustules

  1. Almost Clear Rare papules and/or pustules
  2. Mild Few papules and/or pustules
  3. Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules)
  4. Severe Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions
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 (Actual)

November 15, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMT310-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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