A Phase 2 interventional study of DMT310 and Placebo in Acne Vulgaris, sponsored by Dermata Therapeutics. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-07-22.
Sponsored by Dermata Therapeutics · Phase 2, Interventional, and Treatment
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 181 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Dermata Therapeutics is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Investigator's Global Assessment (IGA) at Randomization Patient has at least 20 inflammatory lesions on the face Patient has at least 20 noninflammatory lesions on the face
Exclusion Criteria:
DMT310 Powder mixed with Hydrogen Peroxide
Drug: DMT310
Placebo powder mixed with Hydrogen Peroxide
Drug: Placebo
Topical Powder
Placebo Topical Powder
Efficacy as measured by lesion counts
Inflammatory and Noninflammatory
Time frame: 12 Weeks
Efficacy as measured by Investigator Global Assessment (IGA)
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
Time frame: 12 Weeks
Incidence of adverse events as a measure of safety and tolerability
Incidence of adverse events as a measure of safety and tolerability
Time frame: 12 Weeks
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Dermata Therapeutics