Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00841776
First received: February 10, 2009
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.


Condition Intervention Phase
Acne
Drug: Duac
Drug: Ziana gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Median Change in Total Propionibacterium Acne (P.Acne) Counts [ Time Frame: Baseline, Weeks 2, 4, 8, 12, & 16 ] [ Designated as safety issue: No ]
    Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.


Secondary Outcome Measures:
  • Median Change in Clindamycin Resistant P. Acne. [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16 ] [ Designated as safety issue: No ]
    Median change in total colony forming units of clindamycin resistant p. acne.

  • Median Change in Erythromycin-resistant P. Acne Counts [ Time Frame: Baseline, Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
    Total colony forming units of erythromycin-resistant p. acnes.

  • Median Change in Total Acne Lesions [ Time Frame: Baseline, Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
    Median Change in Total Acne Lesions

  • Median Change in Inflammatory Acne Lesion Counts [ Time Frame: Baseline, Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
    Median Change in Inflammatory Acne Lesion Counts

  • Median Change in Noninflammaotry Acne Counts [ Time Frame: Baseline, Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
    Median Change in Noninflammaotry Acne Counts


Enrollment: 54
Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Duac gel
Clindamycin and benzoyl peroxide gel
Drug: Duac
Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks
Active Comparator: Ziana gel
Clindamycin and tretinoin gel
Drug: Ziana gel
Clindamycin and tretinoin gel once a day for 12 weeks.

Detailed Description:

To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and tolerability will be assessed.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatient at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
  • Mild to moderate facial acne vulgaris
  • Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

Exclusion Criteria:

  • Female subjects who are pregnant (positive urine pregnancy test), breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
  • Allergy or sensitivity to any component of the test medication
  • Known hypersensitivity to to any component of the investigational formulations
  • Known history of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis
  • Beards or sideburns
  • Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
  • Evidence of recent alcohol or drug abuse
  • Participation in an investigational drug study within 30 days of the baseline visit
  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: NCT00841776

Locations
United States, Kentucky
Dermatology Specialists, PSC
Louisville, Kentucky, United States, 40202
United States, Ohio
Skin We Care Dermatology
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: Cheri A. Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00841776     History of Changes
Other Study ID Numbers: DTG0703
Study First Received: February 10, 2009
Results First Received: April 7, 2010
Last Updated: July 12, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by GlaxoSmithKline:
Acne Vulgaris
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Anti-Infective Agents
Benzoyl Peroxide
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on August 28, 2014