DMT310-009 Topical in the Treatment of Acne Vulgaris

Phase 3

Recruiting

• Conditions: Acne Vulgaris
• Interventions: Drug: DMT310; Drug: Placebo

• Registration Number: NCT06090721
• Lead Sponsor: Dermata Therapeutics

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-19
• Status Verified: 2023-12
• Study Start: 2023-12-08
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-21
• Primary Completion: 2025-01-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 555

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DMT310 Topical Powder	DMT310	DMT310 Powder mixed with Hydrogen Peroxide
Placebo Topical Powder	Placebo	Placebo powder mixed with Hydrogen Peroxide

Primary Outcome Measures

Name	Time	Method
Efficacy as measured by lesion counts	12 weeks	Inflammatory and Noninflammatory
Efficacy as measured by Investigator Global Assessment (IGA)	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events as a measure of safety and tolerability	12 weeks	Incidence of adverse events as a measure of safety and tolerability

Trial Locations

Locations (2)

Center for Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

DermResearch; 🇺🇸 Austin, Texas, United States