Acne Rosacea
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 rosacea.
Interventions
DRUGTopical Powder
Topical Powder mixed with diluent
DRUGPlacebo Topical Powder
Placebo Topical Powder mixed with diluent
Sponsors
Dermata Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 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 papulopustular acne rosacea as determined by: Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory 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 rosacea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as measured by lesion counts | 12 Weeks | Inflammatory lesion counts |
| Efficacy as measured by Investigator Global Assessment (IGA) | 12 Weeks | IGA Scale: 0 Clear No papules and/or pustules 1. Almost Clear Rare papules and/or pustules 2. Mild Few papules and/or pustules 3. Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules) 4. Severe Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions |
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