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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:
ClinicalTrials.gov Identifier:
NCT00361322
First Posted: August 8, 2006
Last Update Posted: July 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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
Intervention Model: Parallel Assignment
Masking: Double
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

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00361322     History of Changes
Other Study ID Numbers: CLSA-HMO-CTIL
First Submitted: August 6, 2006
First Posted: August 8, 2006
Last Update Posted: July 25, 2007
Last Verified: August 2006

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Salicylic Acid
Salicylates
Anti-Inflammatory Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
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