Rosacea
Conditions
Keywords
PreCision, PDI-320, Foam
Brief summary
This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of PDI-320, and the individual components, in adult subjects with rosacea.
Interventions
DRUGPDI-320
DRUGPDI-320 Monad #1
DRUGPDI-320 Monad #2
DRUGVehicle
Sponsors
PreCision Dermatology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has moderate to severe papulopustular rosacea and at least mild erythema and mild telangiectasia. * Subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study. * If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study.
Exclusion criteria
* Subject is pregnant, lactating or is planning to become pregnant during the study. * Subject has any other active dermatological condition on the face that may interfere with the conduct of the study. * Subject has used systemic immunosuppressants within 30 days prior to study start. * Subject has used systemic retinoids within 6 months prior to study start. * Subject has used any topical rosacea therapy within 14 days prior to study start. * Subject has had laser or light therapy on the face within 3 months of study start. * Subject is currently enrolled in an investigational drug or device study. * Subject has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article. * Subject has used vasodilators or adrenergic blocking agents within 6 weeks of study start (except subjects on stable dose for greater than 3 months). * Subject has active ocular rosacea and/or blepharitis/meibomianitis requiring treatment by an ophthalmologist. * Subject has previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics or use of the components of PDI-320.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success Rate based on change in Investigator's Global Assessment (IGA) | Baseline and End of Treatment (up to 12 weeks) | IGA Score Success Rate is defined as the percentage of subjects who achieve Clear (score = 0) or Almost Clear (score = 1) and have at least a 2-grade improvement on the IGA score at the End of Treatment. IGA score is used to evaluate the overall severity of rosacea using a 5-point scale from 0 (clear) to 4 (severe). |
| Absolute change in inflammatory lesion count | Baseline and End of Treatment (up to 12 weeks) | Inflammatory lesions include papules and pustules on the face, and are counted by study personnel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success Rate based on change in IGA (interim time points) | Baseline, Week 4 and Week 8 | IGA Score Success Rate is the same as defined in the Primary Outcome Measures. |
| Absolute change in inflammatory lesion count (interim time points) | Baseline, Week 4 and Week 8 | Inflammatory lesions include papules and pustules on the face, and are counted by study personnel. |
| Change in erythema severity | Baseline and End of Treatment (up to 12 weeks) | The investigator will assess the erythema (skin redness) on the entire face, using a grading scale from 0 (none) to 4 (very severe) |
| Change in telangiectasia severity | Baseline and End of Treatment (up to 12 weeks) | The investigator will assess telangiectasia (small dilated blood vessels near the surface of the skin) on the face, using a grading scale of 0 (none) to 3 (severe). |
Countries
United States
Outcome results
None listed