Alfred Lane
A Double-blind, Placebo-controlled, Pilot Study To Determine the Safety and Efficacy of Ziana (Clindamycin Phosphate 1.2% And Tretinoin 0.025%) Gel For The Treatment of Rosacea over 12 weeks
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Determine safety and efficacy of Ziana gel in people with papulopustular rosacea.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Ziana gel
- Drug: Clindamycin phosphate 1.2% and tretinoin gel 0.025%
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Subjects 18 years of age and older.
2. Clinical diagnosis of papulopustular facial rosacea.
3. A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus pustules).
4. Willing and able to understand and sign informed consent.
5. Able to complete study and comply with study procedures.
Key Exclusion Criteria:
1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
2. History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis, bloody diarrhea) or similar symptoms.
3. Use of topical rosacea treatments in the past 2 weeks.
4. Use of systemic antibiotics in the past 4 weeks.
5. Use of systemic retinoids within the past 3 months.
6. Use of laser or light based rosacea treatments within the past 2 months.
7. Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids as these may impact assessments.
8. Current drug or alcohol abuse.
9. Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or acne vulgaris.
10. Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
11. Subjects who are pregnant or planning a pregnancy.
12. Use of any investigational therapy within the past 4 weeks.
13. Known hypersensitivity or previous allergic reaction to clindamycin or retinoids.
Additional Study Details
Official Title:
A Double-blind, Placebo-controlled, Pilot Study To Determine the Safety and Efficacy of Ziana (Clindamycin Phosphate 1.2% And Tretinoin 0.025%) Gel For The Treatment of Rosacea over 12 weeksAnticipated start date:
2/3/2009Lead Sponsor:
MedicisCollaborator(s):
- Harvard School of Medicine
Investigator(s):
- Dr. Anne Lynn S. Chang
- Alfred T Lane
- Isha Butt Abdullah
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Percentage of subjects who improve in at least 1 category (per Standard Grading System for Rosacea) at Week 12.
- Improvement in Physician Global Assessment at Week 12.
- The absolute change in inflammatory lesion counts (papules and pustules) from baseline to week 12 (end of treatment).
Secondary Outcomes:
- Reduction in transient erythema (flushing) at Week 12.
- Reduction in telangiectasia count at Week 12.
- Reduction of rosacea severity as measured by patient self-assessment at Week 12.
- Incidence of side effects.
Total Number to be Enrolled:
86Total Number to be Enrolled at Stanford:
43More Information
Secondary ID(s):
- IRB Protocol 15425
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/15/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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