NCT00841776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 23, 2010

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

February 10, 2009

Results QC Date

April 7, 2010

Last Update Submit

May 24, 2017

Conditions

Acne

Keywords

Acne VulgarisAcne

Outcome Measures

Primary Outcomes (1)

  • Median Change in Total Propionibacterium Acne (P.Acne) Counts

    Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.

    Baseline, Weeks 2, 4, 8, 12, & 16

Secondary Outcomes (5)

  • Median Change in Clindamycin Resistant P. Acne.

    Baseline, Weeks 2, 4, 8, 12, 16

  • Median Change in Erythromycin-resistant P. Acne Counts

    Baseline, Weeks 2, 4, 8, 12, and 16

  • Median Change in Total Acne Lesions

    Baseline, Weeks 2, 4, 8, 12, and 16

  • Median Change in Inflammatory Acne Lesion Counts

    Baseline, Weeks 2, 4, 8, 12, and 16

  • Median Change in Noninflammaotry Acne Counts

    Baseline, Weeks 2, 4, 8, 12, and 16

Study Arms (2)

Duac gel

ACTIVE COMPARATOR

Clindamycin and benzoyl peroxide gel

Drug: Duac

Ziana gel

ACTIVE COMPARATOR

Clindamycin and tretinoin gel

Drug: Ziana gel

Interventions

DuacDRUG

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

Duac gel
Ziana gelDRUG

Clindamycin and tretinoin gel once a day for 12 weeks.

Ziana gel

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dermatology Specialists, PSC

Louisville, Kentucky, 40202, United States

Location

Skin We Care Dermatology

Mason, Ohio, 45040, United States

Location

Related Publications (1)

  • 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.

    PMID: 20214175RESULT

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate benzoyl peroxide combination

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

August 1, 2007

Primary Completion

November 1, 2008

Study Completion

January 1, 2009

Last Updated

May 25, 2017

Results First Posted

July 23, 2010

Record last verified: 2017-05

Locations

US(2)