Rosacea

Study Background:

Stanford School of Medicine, in partnership with Harvard School of Medicine, is conducting a research study of an experimental topical drug known as Ziana, which contains 1.2% Clindamycin Phosphate and 0.025% Tretinoin.  Ziana is approved by the FDA for treatment of acne vulgaris, but we hope to learn whether this drug is safe and effective for the treatment of papulopustular rosacea.

Rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin. It is considered to be a syndrome encompassing various combinations of the following skin features:  flushing, skin redness, dilated blood vessels, pimples or red bumps, swelling, lesions of the eye and redness of the nose.  The exact cause of rosacea is unknown, but the most commonly seen symptoms include persistent vasodilatation and increased activity of blood circulation in the central part of the face.

This research study is looking for 86 people with papulopustular rosacea in the United States.  Stanford University expects to enroll 43 research participants.  Study participation will require four visits to the Stanford Dermatology Clinic, and will last 12 weeks for each participant.  Participants will receive either study drug or placebo, and will be required to use this medication once per day. 

 

Compensation will be $50 for each completed visit. Medicis is providing financial support and materials for this study.

Study Procedures:

At study visits, the Protocol Director, Anne Chang, MD and her research study staff will perform the following procedures:

Initial Screening Visit
•    Review of demographics (basic information – gender, age, race, etc.)
•    Review of medical history, including concomitant medications (medications that you are currently taking)
•    Review of inclusion and exclusion criteria
•    Physical examination
•    Urine pregnancy test for all women of child bearing potential

A washout period is required if you are currently taking any of the medications or are on any of the treatments listed in our exclusion criteria.  A washout period indicates the amount of time you must remain off of the medication/treatment before beginning this study.  Different medications/treatments have different washout periods, and we will instruct you on this.  If you do not need a washout before treatment, you may enroll and begin the Baseline Visit (Day 1) assessments on the same day.  

Baseline (Day 1)
•    Review of the Subject’s medical history and concomitant medications since Screening Visit
•    Assessment of adherence to inclusion and exclusion criteria (following instructions)
•    Randomization (random assignment) to either the group receiving Ziana or the group receiving vehicle control (You will have a 50% chance of receiving either the study drug or placebo).  The vehicle control refers to a placebo treatment in which no active drug is delivered - only the vehicle used in this preparation is administered.
•    Physician Rosacea Assessments
•    Patient Rosacea Assessments
•    Photographs

Following the baseline visit, you will be instructed to use the study medication (or placebo) once daily at bedtime.  

Interim Assessments (Week 2, 6)
•    Review of the subject’s medical history and concomitant medications since Screening Visit
•    Physician Rosacea Assessment

•    Patient Rosacea Assessment
•    Photographs
•    Assessment of adverse events (any serious complications/problems)
•    Physician Local Tolerability Assessment
•    Subject Rosacea Quality of Life Questionnaire

Final Assessment (Week 12)
•    Review of the subject’s medical history and concomitant medications
•    Physician Rosacea Assessments
•    Patient Rosacea Assessments
•    Photographs
•    Assessment of adverse events
•    Physician Local Tolerability Assessment
•    Subject Rosacea Quality of Life Questionnaire

As a participant, your responsibilities include:
•    Follow the instructions of the Protocol Director and study staff.
•    Take the study drug as instructed.
•    Keep your study appointments.  If it is necessary to miss an appointment, please contact the Protocol Director or research study staff to reschedule as soon as you know you will miss the appointment.
•    Tell the Protocol Director or research study staff about any side effects, doctor visits, or hospitalizations that you may have.
•    Tell the Protocol Director or research staff if you believe you might be pregnant or gotten your partner pregnant.
•    Keep the study drug in a safe place, away from children and for your use only.
•    Complete your questionnaires as instructed.
•    Ask questions as you think of them.
•    Tell the Protocol Director or research staff if you change your mind about staying in the study.

There are risks, discomforts, and inconveniences associated with any research study.  These deserve careful thought.  You should talk with the Protocol Director if you have any questions.

Subjects may or may not receive any benefit from being in the study. Their skin condition may get better, stay the same, or get worse. Information gathered from this study may help other people in the future with rosacea