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

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ClinicalTrials.gov Identifier: NCT00841776
Recruitment Status : Completed
First Posted : February 11, 2009
Results First Posted : July 23, 2010
Last Update Posted : May 25, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Tracking Information
First Submitted Date  ICMJE February 10, 2009
First Posted Date  ICMJE February 11, 2009
Results First Submitted Date  ICMJE April 7, 2010
Results First Posted Date  ICMJE July 23, 2010
Last Update Posted Date May 25, 2017
Study Start Date  ICMJE August 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
Median Change in Total Propionibacterium Acne (P.Acne) Counts [ Time Frame: Baseline, Weeks 2, 4, 8, 12, & 16 ]
Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
Total colony forming units of P. acnes will be counted [ Time Frame: Screening, Baseline, Weeks 2, 4, 8, 12, & 16 ]
Change History Complete list of historical versions of study NCT00841776 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
  • Median Change in Clindamycin Resistant P. Acne. [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16 ]
    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 ]
    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 ]
    Median Change in Total Acne Lesions
  • Median Change in Inflammatory Acne Lesion Counts [ Time Frame: Baseline, Weeks 2, 4, 8, 12, and 16 ]
    Median Change in Inflammatory Acne Lesion Counts
  • Median Change in Noninflammaotry Acne Counts [ Time Frame: Baseline, Weeks 2, 4, 8, 12, and 16 ]
    Median Change in Noninflammaotry Acne Counts
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
Investigator Global Assessment, Overall Disease Severity, Disease Signs and Symptoms, lesion counts, Skin comfort, Assessment of compliance [ Time Frame: All visits ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne
Official Title  ICMJE Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE
  • Drug: Duac
    Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks
  • Drug: Ziana gel
    Clindamycin and tretinoin gel once a day for 12 weeks.
Study Arms  ICMJE
  • Active Comparator: Duac gel
    Clindamycin and benzoyl peroxide gel
    Intervention: Drug: Duac
  • Active Comparator: Ziana gel
    Clindamycin and tretinoin gel
    Intervention: Drug: Ziana gel
Publications * Jackson JM, Fu JJ, Almekinder JL. A randomized, investigator-blinded trial to assess the antimicrobial efficacy of a benzoyl peroxide 5%/ clindamycin phosphate 1% gel compared with a clindamycin phosphate 1.2%/tretinoin 0.025% gel in the topical treatment of acne vulgaris. J Drugs Dermatol. 2010 Feb;9(2):131-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2010)
54
Original Actual Enrollment  ICMJE
 (submitted: February 10, 2009)
51
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00841776
Other Study ID Numbers  ICMJE DTG0703
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline ( Stiefel, a GSK Company )
Study Sponsor  ICMJE Stiefel, a GSK Company
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP