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

Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823901
• Other study ID #: 2008-P-001828
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 14, 2009
• Last updated: June 19, 2012
• Start date: February 2009
• Est. completion date: October 2010

Study information

• Verified date: June 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Currently, there is no known cure for rosacea. The most effective treatment is systemic antibiotics, particularly of the tetracycline family. Topical treatments include metronidazole, antibacterials such as erythromycin and clindamycin, sulfacetamide and benzoyl peroxide. Isotretinoin (Accutane) is also used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel
Applied on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
• Placebo gel
Applied placebo gel with no active medication to entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks

Locations

Country	Name	City	State
United States	CURTIS - Massachussetts General Hospital	Boston	Massachusetts
United States	Department of Dermatology - Stanford School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Medicis Pharmaceutical Corporation

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Pelle MT, Crawford GH, James WD. Rosacea: II. Therapy. J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4. Review. — View 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. — View 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. — View Citation

Wilkin JK, DeWitt S. Treatment of rosacea: topical clindamycin versus oral tetracycline. Int J Dermatol. 1993 Jan;32(1):65-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Number of Inflammatory Lesions From Baseline to Week 12	The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values.	Baseline, week 12	No