Acne Vulgaris
Conditions
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.
Interventions
Sponsors
Dermata Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events as a measure of safety and tolerability | 12 weeks | Incidence of adverse events as a measure of safety and tolerability |
Countries
United States
Outcome results
None listed