Rosacea is a chronic disorder characterized by vascular dilation (persistent erythema) of the nose, cheeks, and forehead which most commonly occurs in patients between the ages of 30 and 60 years.
The study should last 84 days (12 weeks) with 4 visits. A thin layer of Study treatment should be gently massaged into the affected areas on the face once daily for 12 weeks.
- Healthy male or non-pregnant female over age 18.
- Provide written informed consent
- Must have at least 15 but not more than 50 inflammatory facial lesions (i.e., papules/pustules). Lesions involving scalp or eyes will not be included in the count.
- Must have no more than 2 nodules on the face.
- Must have a definite clinical diagnosis from a Doctor or facial papulopustular rosacea.
- Must be willing to minimize external factors that may trigger rosacea flare-ups (e.g., spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds and alcoholic beverages.)
- Must be willing to refrain from using all other topical medications for rosacea during the 12-week treatment period, other than the investigational product.
- In addition to a urine pregnancy test, female participants must be willing to use acceptable forms of birth control from the day of the first dose administration to 30 days after the last administration of the study drug. Must have been using oral birth control for at least 3 months, or other forms of birth control for at least one month.
- Male participants must be willing to use accepted methods of birth control with their partners from the day of the first dose administration to 30 days after the last administration of the study drug.
- Participants who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change brands/types or frequency of use throughout the study.
- Must be willing to understand and comply with the requirements of the protocol, including attendance at the required study visits.
- Must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of facial rosacea. Such conditions include but are not limited to the following: auto-immune disease; acne vulgaris on the face; seborrheic dermatitis on the face; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptions caused by make-up, medication, facial psoriasis and facial eczema.
- Must not have excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of facial rosacea.
- Must not have ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
- Must not currently have or recently have had bacterial folliculitis on the face.
- Must not have used certain topical treatments within 6 weeks of the baseline visit.
- Must not consume excessive amounts of alcohol (greater than 2 drinks per day) or use drugs of abuse (including but not limited to cannabinoids, cocaine, and barbiturates, etc.)
- Must not have participated in an investigational drug study within 30 days prior to baseline visit.
- Must not be members of the same household as other study participants who are enrolled in this study.
If Qualified and you participate you will receive:
- Study Medication at no cost
- Treatment by our Physician and Asthma study team
- Lab work and any required tests at no cost
- Insurance is not required
- Eligible participants in the study will receive reimbursement for time and travel up to $300.00
Take the next step, call us at (757) 627-6798 and ask for the Rosacea enrollment team, better yet, fill out the brief contact form, and we will call you!