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Safety and Efficacy Study of Acnase Creme in the Treatment of Acne Vulgaris I and II

NCT00877409 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2009-04-07

No results posted yet for this study

Summary

The objective of this study is to establish the safety in use of the topical drug Acnase Creme and its effectiveness in treatment of acne grade I (comedones) and II (comedones, papules, pustules).

Conditions

  • Acne Vulgaris

Interventions

DRUG

Benzoyl Peroxide 5% and Sulphur 2%

The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.

DRUG

Vehicle of Acnase

The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.

Sponsors & Collaborators

  • Zurita Laboratorio Farmaceutico Ltda.

    lead INDUSTRY

Principal Investigators

  • Sérgio Schalka, MD · Medcin Instituto da Pele Ltda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00877409 on ClinicalTrials.gov