A PHASE 3 STUDY OF TOLERABILITY, SAFETY, AND EFFICACY, OF DMT310 IN PATIENTS WITH ACNE VULGARIS
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Dermata Therapeutics
- Enrollment
- 520
- Locations
- 2
- Primary Endpoint
- Efficacy as measured by lesion counts
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 9 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo Topical Powder
Placebo powder mixed with Hydrogen Peroxide
Intervention: Placebo (Drug)
DMT310 Topical Powder
DMT310 Powder mixed with Hydrogen Peroxide
Intervention: DMT310 (Drug)
Outcomes
Primary Outcomes
Efficacy as measured by lesion counts
Time Frame: 12 weeks
Inflammatory and Noninflammatory
Efficacy as measured by Investigator Global Assessment (IGA)
Time Frame: 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 Outcomes
- Incidence of adverse events as a measure of safety and tolerability(12 weeks)