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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

Primary Purpose

Acne

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Benzoyl peroxide with clindamycin

Benzoyl peroxide with clindamycin and doxycycline

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

Center for Dermatology, Cosmetic and Laser Surgery
Las Vegas Skin & Cancer Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

BPO with clindamycin foam

BPO + clindamycin foam + doxycycline

Arm Description

Benzoyl peroxide (BPO) wash with clindamycin foam

Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules

Outcomes

Primary Outcome Measures

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)

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.

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)

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 Clear 1.5- Almost Clear/Mild Mild 2.5- Mild/Moderate Moderate 3.5- Moderate/Severe

Secondary Outcome Measures

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

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

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

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 Clear 1.5- Almost Clear/Mild Mild 2.5- Mild/Moderate Moderate 3.5- Moderate/Severe

Full Information

NCT ID

NCT00837213

First Posted

February 4, 2009

Last Updated

May 24, 2017

Sponsor

Stiefel, a GSK Company

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00837213

Brief 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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (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

5. Study Description

Brief 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

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

6. Conditions and Keywords

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

Acne

Keywords

Acne

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BPO with clindamycin foam

Arm Type

Active Comparator

Arm Description

Benzoyl peroxide (BPO) wash with clindamycin foam

Arm Title

BPO + clindamycin foam + doxycycline

Arm Type

Active Comparator

Arm Description

Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules

Intervention Type

Drug

Intervention Name(s)

Benzoyl peroxide with clindamycin

Other Intervention Name(s)

Acne

Intervention Description

Benzoyl peroxide wash - Clindamycin foam

Intervention Type

Drug

Intervention Name(s)

Benzoyl peroxide with clindamycin and doxycycline

Other Intervention Name(s)

Acne

Intervention Description

Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules

Primary Outcome Measure Information:

Title

Percent Change in Inflammatory Acne Lesions From Baseline to Week 16

Description

Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)

Time Frame

Baseline, Week 16

Title

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

Description

Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.

Time Frame

Baseline, Week 16

Title

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

Description

Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)

Time Frame

Baseline, Week 16

Title

Change in Investigator Global Assessment (IGA)

Description

Time Frame

Baseline, Weeks 4, 8,12, and 16

Secondary Outcome Measure Information:

Title

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

Description

Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12

Time Frame

Baseline, Week 12

Title

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

Description

Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12

Time Frame

Baseline, Week 12

Title

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

Description

Percent change in total lesions (chest and back) from baseline to Week 12

Time Frame

Week 12

Title

Percentage of Particpants With IGA Score at Week 16

Description

Time Frame

Baseline, Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

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

Center for Dermatology, Cosmetic and Laser Surgery

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Las Vegas Skin & Cancer Clinic

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89129

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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