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

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00361322
First received: August 6, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: clindamycin phosphate
Drug: salicylic acid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Lesions count at the baseline (week 0)
  • Lesions count at the end of study (week 8)

Estimated Enrollment: 40
Study Start Date: April 2005
Estimated Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361322

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Vera Leibovici, MD Hadassah Medical Organization
Principal Investigator: Arie Ingber, MD, Prof Hadassah Medical Organization
Principal Investigator: Elka Touitou, PhD, Prof The Hebrew University of Jerusalem, Jerusalem, Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00361322     History of Changes
Other Study ID Numbers: CLSA-HMO-CTIL
Study First Received: August 6, 2006
Last Updated: August 6, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Salicylic Acid
Anti-Inflammatory Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 18, 2014