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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:

MedlinePlus related topics: Acne Antibiotics
U.S. FDA Resources

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
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
Anti-Inflammatory Agents
Salicylates
Clindamycin
Clindamycin-2-phosphate
Salicylic Acid
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 13, 2013