An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea



Status:Completed
Conditions:Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:1/1/2014
Start Date:June 2013
End Date:June 2014

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A Multicenter Randomized Evaluator-Blinded Vehicle-Controlled Parallel Group Evaluation of Twice Daily PDI-320 in Comparison to Its Monads in Adults With Rosacea

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.


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.
We found this trial at
2
sites
San Diego, California 92123
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San Diego, CA
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Albuquerque, New Mexico 87106
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Albuquerque, NM
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