NCT00361322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
Last Updated

August 8, 2006

Status Verified

August 1, 2006

First QC Date

August 6, 2006

Last Update Submit

August 6, 2006

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

  • Lesions count at the baseline (week 0)

  • Lesions count at the end of study (week 8)

Interventions

clindamycin phosphateDRUG
salicylic acidDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphateSalicylic Acid

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2006

First Posted

August 8, 2006

Study Start

April 1, 2005

Study Completion

January 1, 2006

Last Updated

August 8, 2006

Record last verified: 2006-08

Locations

IL(1)