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Comparative Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne

Intervention: Benzoyl peroxide with clindamycin (Drug); Benzoyl peroxide with clindamycin and doxycycline (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Stiefel, a GSK Company

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne

Clinical Details

Official title: Comparative Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome:

Percent Change in Inflammatory Acne Lesions From Baseline to Week 16

Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.

Percent Change in Total Acne Lesion Counts From Baseline to Week 16

Change in Investigator Global Assessment (IGA)

Secondary outcome:

Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12

Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12

Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12

Percentage of Particpants With IGA Score at Week 16

Detailed description: To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline once daily in the treatment of moderate acne

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female subjects with acne vulgaris . Able to understand the requirements of

the study and sign informed consent/HIPAA authorization forms. Exclusion Criteria:

- Known hypersensitivity to any of the components of the study drugs or used of

prohibited medications or any medical condition that contraindicate the subject's participation in the clinical study

Locations and Contacts

Center for Dermatology, Cosmetic and Laser Surgery, Fremont, California 94538, United States

Las Vegas Skin & Cancer Clinic, Las Vegas, Nevada 89129, United States

Additional Information

Starting date: August 2007
Last updated: July 12, 2011

Page last updated: August 23, 2015

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