DMT310-001 Topical in the Treatment of Acne Vulgaris

Phase 2

Completed

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

• Registration Number: NCT03536637
• 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: 2018-05-02
• Study First Submitted QC: 2018-05-14
• Study Start: 2018-05-22
• Study First Posted: 2018-05-25
• Status Verified: 2018-06
• Primary Completion: 2018-12-30
• Study Completion: 2019-01-28
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Patient is male or non-pregnant female at least 18 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 but not more than 50 inflammatory lesions on the face Patient has at least 20 but not more than 100 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: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Study Treatment 1	DMT310	DMT310 Powder mixed with Hydrogen Peroxide
Study Treatment 1	Hydrogen Peroxide	DMT310 Powder mixed with Hydrogen Peroxide
Study Treatment 2	DMT310	DMT310 Powder mixed with Placebo Diluent
Study Treatment 3	Placebo	Placebo powder mixed with Hydrogen Peroxide
Control	Placebo	Placebo powder mixed with Placebo Diluent
Study Treatment 3	Hydrogen Peroxide	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 None No evidence of facial acne vulgaris; 1. Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed); 2. Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed; 3. Moderate Many noninflammatory (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 (1)

Dermata Investigational Site; 🇺🇸 Katy, Texas, United States