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Completed

NCT Number: NCT00841776

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

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dermatology Specialists, PSC, Louisville, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duac

Drug

Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks

Ziana gel

Drug

Clindamycin and tretinoin gel once a day for 12 weeks.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Median Change in Total Acne Lesions

    Time frame: Baseline, Weeks 2, 4, 8, 12, and 16

    Median Change in Total Acne Lesions

  4. Median Change in Inflammatory Acne Lesion Counts

    Time frame: Baseline, Weeks 2, 4, 8, 12, and 16

    Median Change in Inflammatory Acne Lesion Counts

  5. Median Change in Noninflammaotry Acne Counts

    Time frame: Baseline, Weeks 2, 4, 8, 12, and 16

    Median Change in Noninflammaotry Acne Counts

Sponsors and collaborators

Lead sponsor

Stiefel, a GSK Company

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Feb 11, 2009
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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