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.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01876550
• Date of registration: 10/06/2013
• Prospective Registration: No
• Primary sponsor: Taro Pharmaceuticals USA
• Public title: 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.
• Scientific title: A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Mupirocin Calcium Cream, 2% and Reference Listed Bactroban® Cream (Mupirocin Calcium Cream, 2%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions.
• Date of first enrolment: February 2013
• Target sample size: 1902
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01876550
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Dominican Republic, El Salvador, Honduras, Panama, Puerto Rico, United States

Contacts

• Name: Symbio CRO
• Affiliation: http://symbioresearch.com

• Name: Catawba Research, LLC
• Affiliation: https://catawbaresearch.com/

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male or nonpregnant females aged 18 months or older with a secondarily
infected traumatic skin lesion such as a laceration, sutured wound, or abrasion.

- The laceration or sutured wound should not exceed 10 cm in length with surrounding
erythema not more than 2 cm from the edge of the lesion. An abrasion should not exceed
100 cm2 in total area with surrounding erythema not more than 2 cm from the edge of
the abrasion.

- Positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from
the secondarily infected traumatic skin lesion.

- Positive Gram stain or Wright stain for confirmation of white blood cells in the
pus/exudate from the secondarily infected traumatic skin lesion.

- Skin Infection Rating Scale total score for the secondarily infected traumatic skin
lesion of at least 8 at baseline.

- Women of childbearing potential, in addition to having a negative urine pregnancy
test, must be willing to use an acceptable form of birth control during the study.
Subjects entering the study who are on hormonal contraceptives must have been on the
method for at least 90 days prior to the study and continue the method for the
duration of the study. Subjects who had used hormonal contraception and stopped must
have stopped no less than 90 days prior to the study.

- Subjects 18 years of age or older must provide Institutional Review Board approved
written informed consent. Subjects under the age of 18 years must have parent or legal
guardian provide Institutional Review Board approved written consent. An assent form
for minors must be completed for subjects under the legal age of consent, depending on
the age range required by state laws.

- Subjects must be willing and able to understand and comply with the requirements of
the study, apply the medication as instructed, return for the required study visits,
comply with therapy prohibitions, and be able to complete the study.

- Subjects must be in good health and free from any clinically significant disease,
other than secondarily infected traumatic skin lesions, that might interfere with the
study evaluations.

Exclusion Criteria:

- Subjects who are pregnant, nursing, or planning a pregnancy within the study
participation period.

- Any dermatological disorder that may interfere with evaluation of the subject's
secondarily infected traumatic skin lesion(s).

- Bacterial skin infection that, because of depth or severity, could not be
appropriately treated with a topical antibiotic.

- Secondarily infected bite or puncture wound.

- Systemic signs or symptoms of infection.

- Requirement for surgical intervention for treatment of the infection prior to study
entry.

- A subject must not have received any topical corticosteroid, topical antibiotic, or
antifungal agent for at least 48 hours (2 days) prior to baseline.

- A subject must not have received any systemic antibiotic or systemic corticosteroid
for at least 7 days prior to baseline.

- Primary or secondary immunodeficiency.

- Diabetes.

- Presence of any other medical condition that might adversely affect the safety of the
study participants or confound the study results.

- History of hypersensitivity or allergy to mupirocin and/or any of the study medication
ingredients.

- Subjects who consume excessive amounts of alcohol, abuse drugs, or have any condition
that would compromise compliance with the protocol.

- Treatment with an investigational drug or device within 30 days prior to study entry.

- Previously enrollment in this study.



Age minimum: 18 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Secondarily Infected Traumatic Skin Lesions

Intervention(s)

Drug: Bactroban® Cream

Drug: Mupirocin Calcium Cream, 2%

Drug: Cream vehicle of test product

Primary Outcome(s)

Clinical cure at visit 4 [Time Frame: 7 days after end of treatment]

Secondary Outcome(s)

Clinical cure at visit 3 [Time Frame: Day 10 (visit 3)]

Bacteriological cure at visit 3 [Time Frame: Day 10 (visit 3)]

Bacteriological cure at visit 4 [Time Frame: 7 days after end of treatment]

Secondary ID(s)

MUPC 1106/1305

Source(s) of Monetary Support

Please refer to primary and secondary sponsors