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

Primary Purpose

Acne

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Duac
Ziana gel
Sponsored by
Stiefel, a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne focused on measuring Acne Vulgaris, Acne

Eligibility Criteria

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

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

Sites / Locations

  • Dermatology Specialists, PSC
  • Skin We Care Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Duac gel

Ziana gel

Arm Description

Clindamycin and benzoyl peroxide gel

Clindamycin and tretinoin gel

Outcomes

Primary Outcome Measures

Median Change in Total Propionibacterium Acne (P.Acne) Counts
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.
Median change in total colony forming units of clindamycin resistant p. acne.
Median Change in Erythromycin-resistant P. Acne Counts
Total colony forming units of erythromycin-resistant p. acnes.
Median Change in Total Acne Lesions
Median Change in Total Acne Lesions
Median Change in Inflammatory Acne Lesion Counts
Median Change in Inflammatory Acne Lesion Counts
Median Change in Noninflammaotry Acne Counts
Median Change in Noninflammaotry Acne Counts

Full Information

First Posted
February 10, 2009
Last Updated
May 24, 2017
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00841776
Brief Title
Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne
Official Title
Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duac gel
Arm Type
Active Comparator
Arm Description
Clindamycin and benzoyl peroxide gel
Arm Title
Ziana gel
Arm Type
Active Comparator
Arm Description
Clindamycin and tretinoin gel
Intervention Type
Drug
Intervention Name(s)
Duac
Intervention Description
Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ziana gel
Intervention Description
Clindamycin and tretinoin gel once a day for 12 weeks.
Primary Outcome Measure Information:
Title
Median Change in Total Propionibacterium Acne (P.Acne) Counts
Description
Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.
Time Frame
Baseline, Weeks 2, 4, 8, 12, & 16
Secondary Outcome Measure Information:
Title
Median Change in Clindamycin Resistant P. Acne.
Description
Median change in total colony forming units of clindamycin resistant p. acne.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16
Title
Median Change in Erythromycin-resistant P. Acne Counts
Description
Total colony forming units of erythromycin-resistant p. acnes.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Median Change in Total Acne Lesions
Description
Median Change in Total Acne Lesions
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Median Change in Inflammatory Acne Lesion Counts
Description
Median Change in Inflammatory Acne Lesion Counts
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Median Change in Noninflammaotry Acne Counts
Description
Median Change in Noninflammaotry Acne Counts
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology Specialists, PSC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Skin We Care Dermatology
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20214175
Citation
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.
Results Reference
result

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

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