Effects of PRK 124 Lotion in Acne Rosacea

Inclusion Criteria

• 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.

Exclusion Criteria

• 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