Clinical trial NCT01828177: An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rosacea
Keywords: PreCision
PDI-320
Foam
Lead sponsor: PreCision Dermatology, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment "Success Rate" based on change in Investigator's Global Assessment (IGA)
timeFrame: Baseline and End of Treatment (up to 12 weeks)
measure: Absolute change in inflammatory lesion count
timeFrame: Baseline and End of Treatment (up to 12 weeks)
Secondary outcomes:
measure: Treatment "Success Rate" based on change in IGA (interim time points)
timeFrame: Baseline, Week 4 and Week 8
measure: Absolute change in inflammatory lesion count (interim time points)
timeFrame: Baseline, Week 4 and Week 8
measure: Change in erythema severity
timeFrame: Baseline and End of Treatment (up to 12 weeks)
measure: Change in telangiectasia severity
timeFrame: Baseline and End of Treatment (up to 12 weeks)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
Study officials:
affiliation: Therapeutics, Inc.
name: Syd Dromgoole, PhD
role: STUDY_DIRECTOR
References: