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

This study has been completed.
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00823901
First received: January 14, 2009
Last updated: June 19, 2012
Last verified: June 2012
  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.


Condition Intervention Phase
Rosacea
Drug: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel
Drug: Placebo gel
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 83
Study Start Date: February 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823901

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:
Additional 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     History of Changes
Other Study ID Numbers: 2008-P-001828
Study First Received: January 14, 2009
Results First Received: April 4, 2011
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 27, 2014