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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841776
• Other study ID #: DTG0703
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2009
• Last updated: May 24, 2017
• Start date: August 2007
• Est. completion date: January 2009

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• Duac
Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks
• Ziana gel
Clindamycin and tretinoin gel once a day for 12 weeks.

Locations

Country	Name	City	State
United States	Dermatology Specialists, PSC	Louisville	Kentucky
United States	Skin We Care Dermatology	Mason	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Stiefel, a GSK Company	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Median Change in Clindamycin Resistant P. Acne.	Median change in total colony forming units of clindamycin resistant p. acne.	Baseline, Weeks 2, 4, 8, 12, 16
Secondary	Median Change in Erythromycin-resistant P. Acne Counts	Total colony forming units of erythromycin-resistant p. acnes.	Baseline, Weeks 2, 4, 8, 12, and 16
Secondary	Median Change in Total Acne Lesions	Median Change in Total Acne Lesions	Baseline, Weeks 2, 4, 8, 12, and 16
Secondary	Median Change in Inflammatory Acne Lesion Counts	Median Change in Inflammatory Acne Lesion Counts	Baseline, Weeks 2, 4, 8, 12, and 16
Secondary	Median Change in Noninflammaotry Acne Counts	Median Change in Noninflammaotry Acne Counts	Baseline, Weeks 2, 4, 8, 12, and 16