Effects of PRK 124 Lotion in Acne Rosacea
Completed · Phase 1/Phase 2
Conditions studied: Acne Rosacea
In brief
The purpose of this open-label study is to determine the tolerance and efficacy of twice-daily application of PRK 124 (Pyratine-6)(0.125%) moisturizing lotion for improving the signs and symptoms of mild to moderate facial rosacea.
Key facts
- Study ID
- NCT00580723
- Run by
- University of California, Irvine
- People needed
- 24
- Starts
- 2007-04-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2014-01-17
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- be at least 21 years old
- be in reasonably good health as defined by the study doctor
- have routine laboratory tests to evaluate your blood cell count, and kidney and liver function
- for females of child-bearing age, not be pregnant or nursing and have a negative urine pregnancy test (except if surgically sterile or at least 1 year menopausal)
- for females, agree to use medically acceptable forms of birth control throughout the entire study (medically acceptable forms of birth control include oral contraceptive ["the pill"], implants such as Norplant®, injectable progesterone [Depo-provera®], diaphragm and spermicide or condoms and spermicide)
- must have mild to moderate acne rosacea
- be willing to refrain from using non-approved lotions, moisturizer, cleansers or lotions on affected facial areas during the treatment period
- be capable of understanding and giving written, voluntary informed consent before study screening
- be willing to consent to facial photographs at baseline and each follow-up visit to monitor treatment with the test product.
You may not qualify if…
- have a history or evidence of any chronic or reoccurring skin disease or disorder (e.g., psoriasis, eczema, etc.) affecting the face
- have known or suspected hypersensitivity to study treatment or any of its ingredients
- have used systemic retinoids within 6 months prior to study entry (e.g., acitretin, isotretinoin)
- have received treatment with systemic corticosteroids (e.g. prednisone) or antibiotics within 1 month
- have used topical treatment to the face with retinoids (e.g. tretinoin, adapalene), or antibiotics or corticosteroids, within 2 weeks prior to study entry
- are unwilling to use a sunscreen with an SPF of 30 during the study
- have participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past 30 days
Where it is running
- UC Irvine Dermatology Clinical Research Center — Irvine, California, United States
Full record on ClinicalTrials.gov
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