DMT310-009 Topical in the Treatment of Acne Vulgaris

A PHASE 3 STUDY OF TOLERABILITY, SAFETY, AND EFFICACY, OF DMT310 IN PATIENTS WITH ACNE VULGARIS

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 vulgaris

Study Overview

• Status: Recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: DMT310; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 555
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dermata Study Director; Phone Number: (858) 223-0883; Email: clinicaltrial@dermatarx.com

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Recruiting
      • Center for Dermatology Clinical Research, Inc.
      • Contact: Marylu Silva; Phone Number: 510-797-0140; Email: marylus@ctr4derm.com
  • Texas
    • Austin, Texas, United States, 78759
      • Recruiting
      • DermResearch
      • Contact: Jennifer Martinez; Phone Number: 512-349-9889; Email: studiesdri@vial.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient sex at birth, male or non-pregnant female at least 9 years of age
• Clinical diagnosis of moderate to severe acne vulgaris as determined by:

Investigator's Global Assessment (IGA) at Randomization; Patient has at least 20 inflammatory lesions and at least 20 noninflammatory 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 acne

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: DMT310 Topical Powder; DMT310 Powder mixed with Hydrogen Peroxide	Drug: DMT310; Topical Powder
Experimental: Placebo Topical Powder; Placebo powder mixed with Hydrogen Peroxide	Drug: Placebo; Placebo Topical Powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy as measured by lesion counts	Inflammatory and Noninflammatory	12 weeks
Efficacy as measured by Investigator Global Assessment (IGA)	0 Clear No evidence of facial acne vulgaris; Almost Clear Few non-inflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed); Mild Several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed; Moderate Many non-inflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed; Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present	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): December 8, 2023
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: DMT310-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No