Overview

This trial is active, not recruiting.

Condition rosacea
Treatments pdi-320, pdi-320 monad #1, pdi-320 monad #2, vehicle
Phase phase 2
Sponsor PreCision Dermatology, Inc.
Start date June 2013
End date June 2014
Trial size 200 participants
Trial identifier NCT01828177, 172-7451-201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Foam, twice daily for up to 12 weeks
pdi-320
(Experimental)
Foam, twice daily for up to 12 weeks
pdi-320 monad #1
(Experimental)
Foam, twice daily for up to 12 weeks
pdi-320 monad #2
(Placebo Comparator)
Foam, twice daily for up to 12 weeks
vehicle

Primary Outcomes

Measure
Treatment "Success Rate" based on change in Investigator's Global Assessment (IGA)
time frame: Baseline and End of Treatment (up to 12 weeks)
Absolute change in inflammatory lesion count
time frame: Baseline and End of Treatment (up to 12 weeks)

Secondary Outcomes

Measure
Treatment "Success Rate" based on change in IGA (interim time points)
time frame: Baseline, Week 4 and Week 8
Absolute change in inflammatory lesion count (interim time points)
time frame: Baseline, Week 4 and Week 8
Change in erythema severity
time frame: Baseline and End of Treatment (up to 12 weeks)
Change in telangiectasia severity
time frame: Baseline and End of Treatment (up to 12 weeks)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Multicenter Randomized Evaluator-Blinded Vehicle-Controlled Parallel Group Evaluation of Twice Daily PDI-320 in Comparison to Its Monads in Adults With Rosacea
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by PreCision Dermatology, Inc..