Impetigo contagiosa MedDRA version: 20.0 Level: PT Classification code 10021531 Term: Impetigo System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10041923 Term: Staphylococcal impetigo System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10042178 Term: Streptococcal impetigo System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: LLT Classificatio
Conditions
Interventions
Trade Name: Fusidinezuur Basic Pharma 20mg/g crème
Product Name: Fusidinezuur Basic Pharma 20mg/g crème
Pharmaceutical Form: Cream
INN or Proposed INN: Fusidic acid
CAS Number: 6990-06-3
Other descrip
Sponsors
Basic Pharma Technologies
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy parameter is clinical efficacy, which will be assessed at the follow up visit after 7 days. For the determination of this clinical efficacy, the overall impetigo condition will be assessed. The supposition in planning the study is that Fusidic acid hydrophilic cream 20 mg/g will possess similar efficacy and tolerability/safety to the Fucidin® cream, since the two products are similarly formulated and the dose regimen, duration, study population and study design are all very similar to those used in the previous Koning et al. 2002 study. Given these facts, it will be very unlikely that Fusidic acid hydrophilic cream 20 mg/g will prove clinically superior to Fucidin® cream in either efficacy or tolerability. Therefore, the important objective in the present study is to demonstrate that the Fusidic acid hydrophilic cream 20 mg/g is not clinically inferior by a prespecified amount to Fucidin® cream, since in practice, these products are intended to be interchangeable. Fusidic acid hydrophilic cream (Basic Pharma Technologies) and comparing it to the rate of “cure” after one week of treatment with Fucidin® cream (Leo Pharma). Four possible endpoints are described: 1. Cured: defined as the complete absence of lesions or the lesions have become dry and without crusts. Remaining local erythema of the intact skin or such progress that no further antibiotic therapy is needed, is acceptable as well. 2. Improvement: defined as a decline in the affected area, number of lesions or in both, as compared to a previous visit (additional antibiotic therapy is still required). 3. Failure: insufficient improvement or deterioration (e.g. lesions remain crusted and/or have exudate, lesions have a yellow/honey colored crust or the area increases with or without an increase in the number of lesions), as compared to a previous visit (additional antibiotic therapy is required). 4. Unable to determine: the effect of the treatment is not assessable ( | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The rate of “improvement”, and “failure” after one week 2. The rate of “cure”, “improvement”, and “failure” after two weeks 3. The rate of bacterial cure (elimination of causative pathogens in persisting lesions or the unavailability of a swab if lesions were cured) after one and two weeks 4. Safety analysis: comparison of tolerance and adverse event profiles ;Timepoint(s) of evaluation of this end point: 1 week, 2 weeks. | — |
Countries
Belgium, Canada
Contacts
Public ContactCEO
AESCULAPE CRO
Outcome results
None listed