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

NCT00823901 | Completed Phase 2 Results DMC

• 1 other identifier: 2008-P-001828
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

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.

Conditions

Rosacea

Keywords

rosacea; clindamycin; tretinoin; clinical study; treatment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Clindamycin/Tretinoin Gel

EXPERIMENTAL

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

Placebo gel

PLACEBO COMPARATOR

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

Interventions

Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel DRUG

Applied on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks

Also known as: Ziana

Clindamycin/Tretinoin Gel

Placebo gel DRUG

Applied placebo gel with no active medication to entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks

Also known as: placebo

Placebo gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Medicis Pharmaceutical Corporation: collaborator

Study Sites (2)

Department of Dermatology - Stanford School of Medicine

Stanford, California, 94305, United States

Location

CURTIS - Massachussetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

• Pelle MT, Crawford GH, James WD. Rosacea: II. Therapy. J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4. doi: 10.1016/j.jaad.2004.03.033.

  PMID: 15389184 BACKGROUND

• 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. doi: 10.1016/j.jaad.2004.01.048. No abstract available.

  PMID: 15153893 BACKGROUND

• 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. doi: 10.1067/mjd.2002.120625. No abstract available.

  PMID: 11907512 BACKGROUND

• Wilkin JK, DeWitt S. Treatment of rosacea: topical clindamycin versus oral tetracycline. Int J Dermatol. 1993 Jan;32(1):65-7. doi: 10.1111/j.1365-4362.1993.tb00974.x.

  PMID: 8425809 BACKGROUND

• Diaz BV, Lenoir MC, Ladoux A, Frelin C, Demarchez 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. doi: 10.1074/jbc.275.1.642.

  PMID: 10617662 BACKGROUND

• 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.

  PMID: 22395584 DERIVED

MeSH Terms

Conditions

Rosacea

Interventions

clindamycin phosphate; Tretinoin; Gels; clindamycin, tretinoin drug combination

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

This study is limited by relatively small number of subjects. In addition, overall assessment of acne rosacea severity as determined by subjects' self-assessment was not performed.

Results Point of Contact

• Title: Alexandra B. Kimball, MD
• Organization: MGH CURTIS

harvardskinstudies@partners.org

617-726-5066

Study Officials

• Alexa Kimball, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Unit for Research Trials in Skin

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 16, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 25, 2012
• Results First Posted: June 15, 2012

Record last verified: 2012-06

Locations

US (2)