An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea
- Conditions
- Rosacea
- Interventions
- Registration Number
- NCT01828177
- Lead Sponsor
- PreCision Dermatology, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PDI-320 PDI-320 Foam, twice daily for up to 12 weeks PDI-320 Monad #1 PDI-320 Monad #1 Foam, twice daily for up to 12 weeks PDI-320 Monad #2 PDI-320 Monad #2 Foam, twice daily for up to 12 weeks Vehicle Vehicle Foam, twice daily for up to 12 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (2)
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States