Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris
Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: clindamycin phosphate (Drug); salicylic acid (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Hadassah Medical Organization Official(s) and/or principal investigator(s): Vera Leibovici, MD, Principal Investigator, Affiliation: Hadassah Medical Organization Arie Ingber, MD, Prof, Principal Investigator, Affiliation: Hadassah Medical Organization Elka Touitou, PhD, Prof, Principal Investigator, Affiliation: The Hebrew University of Jerusalem, Jerusalem, Israel
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.
Clinical Details
Official title: Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Lesions count at the baseline (week 0)Lesions count at the end of study (week 8)
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hadassah Medical Organization, Jerusalem 91120, Israel
Additional Information
Starting date: April 2005
Last updated: August 6, 2006
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