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

Status unconfirmed · Phase 2

Conditions studied: Rosacea

In brief

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.

Key facts

Study ID

NCT01828177

Run by

PreCision Dermatology, Inc.

People needed

200

Starts

2013-06-01

Expected to finish

2014-06-01

Last updated by the study team

2014-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Therapeutics Clinical Research — San Diego, California, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.