Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

NCT02090764 | Completed Phase 3 Results DMC

• 1 other identifier: P-110881-01
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief Summary

This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.

Conditions

Impetigo

Outcome Measures

Primary Outcomes (1)

• Clinical Success

  Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain.

  Visit 3 (Day 6-7)

Study Arms (2)

Ozenoxacin

EXPERIMENTAL

ozenoxacin cream 1%

Drug: Ozenoxacin

Placebo

PLACEBO COMPARATOR

Placebo cream

Drug: Placebo

Interventions

Ozenoxacin DRUG

Ozenoxacin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients \< 12 years the total area will not exceed a maximum of 2% of the body surface area.
• Total Skin Infection Rating Scale (SIRS) score of at least 3, including pus/exudate score of at least 1

You may not qualify if:

• Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.
• Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)

Sponsors & Collaborators

• Ferrer Internacional S.A.: lead

Study Sites (1)

Caparra Internal Medicine Center

Río Grande, Puerto Rico

Location

Related Publications (2)

• Hebert AA, Albareda N, Rosen T, Torrelo A, Grimalt R, Rosenberg N, Zsolt I, Masramon X. Topical Antibacterial Agent for Treatment of Adult and Pediatric Patients With Impetigo: Pooled Analysis of Phase 3 Clinical Trials. J Drugs Dermatol. 2018 Oct 1;17(10):1051-1057.

  PMID: 30365584 DERIVED

• Rosen T, Albareda N, Rosenberg N, Alonso FG, Roth S, Zsolt I, Hebert AA. Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jul 1;154(7):806-813. doi: 10.1001/jamadermatol.2018.1103.

  PMID: 29898217 DERIVED

MeSH Terms

Conditions

Impetigo

Interventions

ozenoxacin

Condition Hierarchy (Ancestors)

Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Ferrer Internacional, S.A.

nalbareda@ferrer.com

+34 93 509 32 75

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 18, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 20, 2024
• Results First Posted: May 19, 2016

Record last verified: 2016-06

Locations

PR (1)