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

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

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: Benzoyl peroxide with clindamycin; Drug: Benzoyl peroxide with clindamycin and doxycycline

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

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology, Cosmetic and Laser Surgery
  • Nevada
    • Las Vegas, Nevada, United States, 89129
      • Las Vegas Skin & Cancer Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BPO with clindamycin foam; Benzoyl peroxide (BPO) wash with clindamycin foam	Drug: Benzoyl peroxide with clindamycin; Benzoyl peroxide wash - Clindamycin foam; Other Names: Acne
Active Comparator: BPO + clindamycin foam + doxycycline; Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules	Drug: Benzoyl peroxide with clindamycin and doxycycline; Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules; Other Names: Acne

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Inflammatory Acne Lesions From Baseline to Week 16	Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)	Baseline, Week 16
Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.	Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.	Baseline, Week 16
Percent Change in Total Acne Lesion Counts From Baseline to Week 16	Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)	Baseline, Week 16
Change in Investigator Global Assessment (IGA)	Change in Investigator Global Assessment (IGA) Average values chest and back. IGA scale: 0 - Clear 0.5 - Clear/almost clear; Almost Clear1.5- Almost Clear/Mild; Mild2.5- Mild/Moderate; Moderate 3.5- Moderate/Severe	Baseline, Weeks 4, 8,12, and 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12	Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12	Baseline, Week 12
Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12	Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12	Baseline, Week 12
Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12	Percent change in total lesions (chest and back) from baseline to Week 12	Week 12
Percentage of Particpants With IGA Score at Week 16	Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment IGA: 0 - Clear 0.5 - Clear/almost clear; Almost Clear1.5- Almost Clear/Mild; Mild2.5- Mild/Moderate; Moderate 3.5- Moderate/Severe	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Stiefel, a GSK Company
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: February 4, 2009
• First Submitted That Met QC Criteria: February 4, 2009
• First Posted (Estimate): February 5, 2009

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
• Other Study ID Numbers: EVF0701