Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361322
• Other study ID #: CLSA-HMO-CTIL
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 6, 2006
• Last updated: August 6, 2006
• Start date: April 2005
• Est. completion date: January 2006

Study information

• Verified date: August 2006
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

The concept behind our study was to combine an effect of antibiotic and anti-inflammatory agents for a more efficient acne therapy directed at the factors involved in the pathophysiology of the disease. For this purpose we evaluated a combination of clindamycin phosphate and salicylic acid in a non-irritating carrier.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2006
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• mild to moderate acne vulgaris;

• at least 5 lesions on the face;

• a one-month wash-out period was established for any topical or systemic drug use for treatment of acne vulgaris.

Exclusion Criteria:

• acne that was primarily truncal, nodular, or due to secondary causes/internal disease;

• pregnancy, breastfeeding, or intention to become pregnant;

• another dermatological disease of the face;

• significant systemic disease;

• any drug/alcohol addiction;

• interacting medication;

• known hypersensitivity to study medications;

• history of chronic disease treated with medications which might affect acne condition and treatment outcome (e.g. corticosteroids, lithium, isoniazid, anti-androgens, phenytoin, phenobarbital) in the preceding month

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• clindamycin phosphate

• salicylic acid

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesions count at the baseline (week 0)
Primary	Lesions count at the end of study (week 8)