A Randomized, Double-Blind, Parallel Group, Equivalence, Multicenter Phase III Trial to Compare the Efficacy and Safety of Fusidic Acid Hydrophilic Cream 20 mg/g and Fucidin® Cream in the Treatment of Adult and Pediatric Subjects with Impetigo.

Phase 1

• Conditions: Impetigo contagiosa; MedDRA version: 20.0Level: PTClassification code 10021531Term: ImpetigoSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10041923Term: Staphylococcal impetigoSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10042178Term: Streptococcal impetigoSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: LLTClassification code 10021535Term: Impetigo NOSSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: LLTClassification code 10041939Term: Staphylococcus aureus impetigoSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: LLTClassification code 10042200Term: Streptococcus pyogenes impetigoSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: LLTClassification code 10021533Term: Impetigo contagiousSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-002219-24-BE
• Lead Sponsor: Basic Pharma Technologies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-13
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Subjects having a clinical diagnosis of localized impetigo contagiosa (not the extensive forms)
2.Skin Infection Score: more than 7 points
3.Subject age: =18 months of age
4.Subject (and/or parent or legal guardian) is willing to comply with the protocol, remain available for follow up visits, and provide informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

If a subject meets one of the stated exclusion criteria, he/she cannot participate in this study. The exclusion criteria will apply to all subjects at all study visits.

1.Subjects for whom no signed and dated informed consent is obtained
2.Subjects whose temperature is >38.5°C (higher than low grade fever)
3.Subjects who have extensive forms of impetigo, defined as:
•More than 10 lesions
•Total affected area >100 cm2
•The surrounding redness extends >2 cm from the edge of the lesions
4.Subjects with secondary impetigo, where the infection is secondary to some other underlying skin disease
5.Subjects that have used other medications or treatments prior to enrollment in the study, including:
•For 24 hours prior to entry: subjects should not have been treated with topical steroids, topical retinoids, topical antibiotics or other ingredients considered as antibacterial, such as salicylic acid
•For 1 week prior to entry: subjects should not have utilized medicated shampoos or medicated cleansers of any type. Non-medicated cleansers and emollients are permitted at the discretion of the investigator
•For 1 month prior to entry: subjects should not have been treated with UV-lamp irradiation, oral antibiotics or parenteral corticosteroids
6.Subjects who have other significant skin infections, diseases or disorders of the skin, including:
•Systemic erythema (skin redness), not related to impetigo
•Psoriasis
•Allergic rashes
•Viral or fungal infections of the skin
•Eczema
•Contact dermatitis
•Herpes simplex virus
•Discoid lupus
•Scabies
•Necrotizing fasciitis
•Other significant diseases of the skin
7.Subjects with a recent history of other severe systemic diseases within 3 months prior to enrollment, including:
•Severely impaired liver or renal function
•Severe cardiovascular disease
•Severe neurological disease
•Immunocompromised patient
•Severe disease that may interfere with the study evaluations
8.Subjects with a serious disease that potentially could be life threatening (including laboratory testing results) or that may interfere with the objective of the study, according to the opinion of the investigator
9.Subjects requiring any significant concomitant medication that may affect the results of the study
10.Subjects with sunburn and those who may experience considerable exposure to sunlight during the study period (including UV lamps)
11.Subjects who have a history of hypersensitivity to fusidic acid or to any other component of the study medication
12.Pregnant subjects, female subjects planning pregnancy during the study and breast- feeding subjects
13.Subjects that participated in another clinical study within 3 months prior to the enrolment
14.Subjects who are considered as unreliable or unlikely to be available during the study
15.Subjects that previously participated in the present trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified