Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea
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ClinicalTrials.gov Identifier: NCT00823901 |
Recruitment Status :
Completed
First Posted : January 16, 2009
Results First Posted : June 15, 2012
Last Update Posted : June 25, 2012
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Condition or disease | Intervention/treatment | Phase |
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Rosacea | Drug: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel Drug: Placebo gel | Phase 2 Phase 3 |
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 |
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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
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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.
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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 |
- 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.

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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:
- Subjects 18 years of age and older.
- Clinical diagnosis of papulopustular facial rosacea.
- A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus pustules).
- Willing and able to understand and sign informed consent.
- Able to complete study and comply with study procedures.
Exclusion Criteria:
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
- 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.
- Use of topical rosacea treatments in the past 2 weeks.
- Use of systemic antibiotics in the past 4 weeks.
- Use of systemic retinoids within the past 3 months.
- Use of laser or light based rosacea treatments within the past 2 months.
- Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids as these may impact assessments.
- Current drug or alcohol abuse.
- 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.
- 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.
- Subjects who are pregnant or planning a pregnancy.
- Use of any investigational therapy within the past 4 weeks.
- Known hypersensitivity or previous allergic reaction to clindamycin or retinoids

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 ClinicalTrials.gov identifier (NCT number): NCT00823901
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 |
Principal Investigator: | Alexa Kimball, MD, MPH | Massachusetts General Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
Results First Posted: | June 15, 2012 |
Last Update Posted: | June 25, 2012 |
Last Verified: | June 2012 |
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