Back to resultsEfficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
clindamycin phosphate
salicylic acid
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility 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
Sites / Locations
- Hadassah Medical Organization
Outcomes
Primary Outcome Measures
Lesions count at the baseline (week 0)
Lesions count at the end of study (week 8)
Secondary Outcome Measures
Full Information
NCT ID
NCT00361322
First Posted
August 6, 2006
Last Updated
August 6, 2006
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00361322
Brief Title
Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris
Official Title
Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
clindamycin phosphate
Intervention Type
Drug
Intervention Name(s)
salicylic acid
Primary Outcome Measure Information:
Title
Lesions count at the baseline (week 0)
Title
Lesions count at the end of study (week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Leibovici, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arie Ingber, MD, Prof
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elka Touitou, PhD, Prof
Organizational Affiliation
The Hebrew University of Jerusalem, Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris
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