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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823901
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : June 15, 2012
Last Update Posted : June 25, 2012
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital

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.

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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

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

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.

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00823901

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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
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Principal Investigator: Alexa Kimball, MD, MPH Massachusetts General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital Identifier: NCT00823901    
Other Study ID Numbers: 2008-P-001828
First Posted: January 16, 2009    Key Record Dates
Results First Posted: June 15, 2012
Last Update Posted: June 25, 2012
Last Verified: June 2012
Keywords provided by Alexandra Kimball, Massachusetts General Hospital:
clinical study
Additional relevant MeSH terms:
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Skin Diseases
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents