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Completed

NCT Number: NCT00361322

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clindamycin Phosphate

Drug

Salicylic acid

Drug

Primary outcomes

  1. Lesions count at the baseline (week 0)

  2. Lesions count at the end of study (week 8)

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris

Important dates

Study start
2005
Study completion
2006
First posted
Aug 8, 2006
Registry last updated
Aug 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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