DMT310-009 Topical in the Treatment of Acne Vulgaris

NCT06090721 | Completed Phase 3 FDA Drug

• 1 other identifier: DMT310-009
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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 1. Almost Clear Few non-inflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed) 2. Mild Several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 3. Moderate Many non-inflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 4. 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 Outcomes (1)

• Incidence of adverse events as a measure of safety and tolerability

  12 weeks

Study Arms (2)

DMT310 Topical Powder

EXPERIMENTAL

DMT310 Powder mixed with Hydrogen Peroxide

Drug: DMT310

Placebo Topical Powder

EXPERIMENTAL

Placebo powder mixed with Hydrogen Peroxide

Drug: Placebo

Interventions

DMT310 DRUG

Topical Powder

DMT310 Topical Powder

Placebo DRUG

Placebo Topical Powder

Placebo Topical Powder

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dermata Therapeutics: lead

Study Sites (2)

Center for Dermatology Clinical Research, Inc.

Freemont, California, 94538, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: December 8, 2023
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)