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

Primary Purpose

Rosacea

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel

Placebo gel

About this trial

This is an interventional treatment trial for Rosacea focused on measuring rosacea, clindamycin, tretinoin, clinical study, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Dermatology - Stanford School of Medicine
CURTIS - Massachussetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clindamycin/Tretinoin Gel

Placebo gel

Arm Description

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

Participants applied Placebo gel with no active medication on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00823901

First Posted

January 14, 2009

Last Updated

June 19, 2012

Sponsor

Massachusetts General Hospital

Collaborators

Medicis Pharmaceutical Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00823901

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Medicis Pharmaceutical Corporation

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosacea

Keywords

rosacea, clindamycin, tretinoin, clinical study, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clindamycin/Tretinoin Gel

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo gel

Arm Type

Placebo Comparator

Arm Description

Participants applied Placebo gel with no active medication on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel

Other Intervention Name(s)

Ziana

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo gel

Other Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Change in Number of Inflammatory Lesions From Baseline to Week 12

Description

Time Frame

Baseline, week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexa Kimball, MD, MPH

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology - Stanford School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

CURTIS - Massachussetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15389184

Citation

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.

Results Reference

background

PubMed Identifier

15153893

Citation

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.

Results Reference

background

PubMed Identifier

11907512

Citation

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.

Results Reference

background

PubMed Identifier

8425809

Citation

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.

Results Reference

background

PubMed Identifier

10617662

Citation

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.

Results Reference

background

PubMed Identifier

22395584

Citation

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.

Results Reference

derived

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

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