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

Acne Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837213
• Other study ID #: EVF0701
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2009
• Last updated: May 24, 2017
• Start date: August 2007
• Est. completion date: August 2008

Study information

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

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• Benzoyl peroxide with clindamycin
Benzoyl peroxide wash - Clindamycin foam
• Benzoyl peroxide with clindamycin and doxycycline
Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules

Locations

Country	Name	City	State
United States	Center for Dermatology, Cosmetic and Laser Surgery	Fremont	California
United States	Las Vegas Skin & Cancer Clinic	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Stiefel, a GSK Company	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Baseline, Weeks 4, 8,12, and 16
Secondary	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
Secondary	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
Secondary	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
Secondary	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	Baseline, Week 16