Boston, Massachusetts 02114


Purpose:

The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel are effective and safe in the treatment of papulopustular rosacea.


Criteria:

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. 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


Study is Available At:


Original ID:

2008-P-001828


NCT ID:

NCT00823901


Secondary ID:


Study Acronym:


Brief Title:

Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea


Official Title:

A Double-Blind, Placebo-Controlled, Pilot Study to Determine the Safety and Efficacy of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel For The Treatment of Rosacea Over 12 Weeks


Overall Status:

Recruiting


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

86


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Alexa Kimball, MD, MPH
Principal Investigator
Massachusetts General Hospital

Study Dates

Start Date:February 2009
Completion Date:December 2010
Completion Type:Anticipated
Primary Completion Date:September 2010
Primary Completion Type:Anticipated
Verification Date:May 2010
Last Changed Date:May 3, 2010
First Received Date:January 14, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Reduction in transient erythema (flushing) at Week 12.
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:The absolute change in inflammatory lesion counts (papules and pustules) from baseline to week 12 (end of treatment).
Time Frame:12 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Clindamycin Phosphate 1.2% And Tretinoin 0.025% Ge
Description:apply to the face at bed time
Arm Name:Clindamycin/Tretinoin Gel
Intervention Type:Drug
Name:placebo
Description:placebo gel - apply to face at bedtime
Arm Name:2
Other Name:placebo

Study Arms

Study Arm Type:Experimental
Arm Name:Clindamycin/Tretinoin Gel
Description:Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel
Study Arm Type:Placebo Comparator
Arm Name:2

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Medicis Pharmaceutical Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Pelle MT, Crawford GH, James WD. Rosacea: II. Therapy. J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4. Review.
PMID:15389184
Reference Type:Reference
Citation:Wilkin J, Dahl M, Detmar M, Drake L, Liang MH, Odom R, Powell F; National Rosacea Society Expert Committee. Standard grading system for rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004 Jun;50(6):907-12. No abstract available.
PMID:15153893
Reference Type:Reference
Citation:Wilkin J, Dahl M, Detmar M, Drake L, Feinstein A, Odom R, Powell F. Standard classification of rosacea: Report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002 Apr;46(4):584-7. No abstract available.
PMID:11907512
Reference Type:Reference
Citation:Wilkin JK, DeWitt S. Treatment of rosacea: topical clindamycin versus oral tetracycline. Int J Dermatol. 1993 Jan;32(1):65-7.
PMID:8425809
Reference Type:Reference
Citation:Diaz BV, Lenoir MC, Ladoux A, Frelin C, Démarchez M, Michel S. Regulation of vascular endothelial growth factor expression in human keratinocytes by retinoids. J Biol Chem. 2000 Jan 7;275(1):642-50.
PMID:10617662

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.