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

• ClinicalTrials.gov Identifier: NCT00823901
• Recruitment Status: Completed
• First Posted: January 16, 2009
• Results First Posted: June 15, 2012
• Last Update Posted: June 25, 2012
• Sponsor: Massachusetts General Hospital
• Collaborator: Medicis Pharmaceutical Corporation
• Information provided by (Responsible Party): Alexandra Kimball, Massachusetts General Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Rosacea	Drug: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel; Drug: Placebo gel	Phase 2; Phase 3

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: February 2009
• Actual Primary Completion Date: October 2010
• Actual Study Completion Date: October 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Clindamycin/Tretinoin Gel; Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, chin, cheeks) once daily at night for 12 weeks	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; Other Name: Ziana
Placebo Comparator: Placebo gel; Participants applied Placebo gel with no active medication on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks.	Drug: Placebo gel; Applied placebo gel with no active medication to entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks; Other Name: placebo

Outcome Measures

Primary Outcome Measures :

1. Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 [ Time Frame: Baseline, 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Department of Dermatology - Stanford School of Medicine

Stanford, California, United States, 94305

United States, Massachusetts

CURTIS - Massachussetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Medicis Pharmaceutical Corporation

Investigators

• Principal Investigator: Alexa Kimball, MD, MPH; Massachusetts General Hospital

More Information

Publications:

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

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.

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.

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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chang AL, Alora-Palli M, Lima XT, Chang TC, Cheng C, Chung CM, Amir O, Kimball AB. A randomized, double-blind, placebo-controlled, pilot study to assess the efficacy and safety of clindamycin 1.2% and tretinoin 0.025% combination gel for the treatment of acne rosacea over 12 weeks. J Drugs Dermatol. 2012 Mar;11(3):333-9.

• Responsible Party: Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00823901
• Other Study ID Numbers: 2008-P-001828
• First Posted: January 16, 2009
• Results First Posted: June 15, 2012
• Last Update Posted: June 25, 2012
• Last Verified: June 2012

Keywords provided by Alexandra Kimball, Massachusetts General Hospital:

rosacea; clindamycin; tretinoin; clinical study; treatment

Additional relevant MeSH terms:

Rosacea; Skin Diseases; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Keratolytic Agents; Dermatologic Agents