Multicenter, Double Blind, Randomized, Parallel Groups, Controlled with Vehicle Study to Determine the Clinical Bioequivalence of a 2% Mupirocin Topical Ointment and Bactroban Ointment in Subjects with Impetigo

Not Applicable

• Conditions: -L01; L01

• Registration Number: PER-048-06
• Lead Sponsor: Glemmark Pharnaceuticals. INC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Complete an Informed Consent Process, including signature and date of an Informed Consent Form. In the case of minors, it will be necessary for their parent or guardian to sign the Informed Consent Form. The subjects will give their assent in writing whenever possible.
2. All female subjects who are of reproductive age should have a negative urine pregnancy test and commit to abstinence, or use prescription contraceptives and use a contraceptive barrier device along with a spermicidal product throughout the entire duration of the study.
3. The subject is voluntary and able to meet the requirements of the study.
4. The subject has a diagnosis of impetigo.
5. The subject has a score of> 8 on the SIRS Cutaneous Infection Scale which is based on the sum of individual Blister scores, Exudate / Pus, Crust, Erythema / Inflammation, and Itch / Pain.

Exclusion Criteria

1. The subject must not be less than 18 months of age at the time of
enroll.
2. The woman who is the subject of the study should not be pregnant or breastfeeding, nor should she plan to become pregnant during the study period.
3. Subjects with extended blister impetigo, cellulitis, furunculosis, abscesses and chronic dermatitis should be excluded from the study. Subjects with more than three lesions should be evaluated to determine if topical therapy is appropriate.
4. Subjects with lesions secondary infections caused by animal, trauma, or surgery will be excluded.
5. Subjects who have used a test should be excluded from the study.
topical or systemic or antimicrobial antibiotic, or antibacterial soap within 24 hours.
6. Subjects with a history of renal failure or active kidney disease should be excluded from the study.
7. Any subject with a documented history of hypersensitivity to the investigational mupirocin product, other related agents, or who knows that he / she is allergic, hypersensitive, or for some other reason intolerant to any one, should be excluded from the study.
component of the study medications.
8. The subject should not be taking any cytotoxic, cytostatic or immunosuppressive agent, within 30 days before enrolling in the study.
9. All subjects with a history of treatment for alcohol or drug abuse within the last year should be excluded from the study.
10. The presence of any condition for which the therapy with the research product is clinically contraindicated, or of any condition that prevents the subject from participating in the study.
11. The subject must not have taken any experimental or investigational drug within 30 days before enrolling.

Study & Design

• Study Type: Interventional
• Study Design: Not specified