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A Study to Evaluate the Safety and Bioequivalence of Mupirocin Calcium Cream, 2% and Bactroban® Cream and Compare Both to a Vehicle in Treatment of Secondarily Infected Traumatic Skin Lesions.

NCT01876550 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1902

Last updated 2019-05-09

No results posted yet for this study

Summary

The primary objective of this study is to determine the comparability of the safety and efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily infected traumatic skin lesions. It will also be determined whether the efficacy of each of the active treatments is superior to that of the vehicle cream (placebo).

Conditions

  • Secondarily Infected Traumatic Skin Lesions

Interventions

DRUG

Mupirocin Calcium Cream, 2%

Mupirocin Calcium Cream, 2% (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days.

DRUG

Bactroban® Cream

Bactroban® Cream (mupirocin calcium cream, 2%) (GlaxoSmithKline) applied topically 3 times per day for 10 consecutive days.

DRUG

Cream vehicle of test product

Cream vehicle of test product (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Symbio CRO · http://symbioresearch.com

  • Catawba Research, LLC · https://catawbaresearch.com/

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-02-28
Completion
2019-05-06

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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 NCT01876550 on ClinicalTrials.gov