DMT310-005 Topical in the Treatment of Acne Rosacea

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: Acne Rosacea
• Intervention / Treatment: Drug: Topical Powder; Drug: Placebo Topical Powder

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78759
      • Dermata Investigational Site

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

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	Inflammatory lesion counts	12 Weeks
Efficacy as measured by Investigator Global Assessment (IGA)	IGA Scale: 0 Clear No papules and/or pustules; Almost Clear Rare papules and/or pustules; Mild Few papules and/or pustules; Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); 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	Incidence of adverse events as a measure of safety and tolerability	12 Weeks

Collaborators and Investigators

• Sponsor: Dermata Therapeutics

Study record dates

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: Skin Diseases; Rosacea
• 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