ACNASE
A Monocentric, Single-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of the Topical Drug Acnase Creme in the Treatment of Acne Vulgaris I and II
Sponsor study identifier
Secondary identifiers
interventional
80
1 country
1
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 6, 2009
Actual (reported)April 7, 2009
Actual (reported)July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Average clinical development of target lesions of the groups for each experimental time.
12 weeks
Clinical evolution of the acne through the counting of inflammatory and non - inflammatory lesions.
12 weeks
Evaluation of oily skin through the clinical evaluation with four-point scale (absent, mild, moderate, intense)
12 weeks
Observation of occurrence and intensity of clinical parameters erythema, scaling, itching and burning through the clinical evaluation with four-point scale (absent, mild, moderate, severe).
12 weeks
The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.
The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.
Medcin Instituto da Pele Ltda.
Osasco, São Paulo, 06023-000, Brazil
Sérgio Schalka, MD
Medcin Instituto da Pele Ltda
First Submitted
April 6, 2009
First Posted
April 7, 2009
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Estimated (date passed)Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 7, 2009
Record last verified: 2009-04
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Source: ClinicalTrials.gov.
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