NCT02582177

Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis

Phase 3 Study, Randomized, Double-blind, Parallel to Evaluate Ketoconazole and Betamethasone Dipropionate(Candicort®) Compared to Clotrimazole and Dexamethasone Acetate(Baycuten N®) in Relief of Fungal Infections/Dermatophytosis Symptoms.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the no-inferiority of the ketoconazole20mg/g and betamethasone dipropionate 0.64 mg/g association (Candicort®) cream versus clotrimazole 10mg and dexamethasone acetate 0.443 mg/g association (Baycuten N®) cream, general relief of signs and symptoms (erythema, maceration, peeling, blistering / papules / pustules, itching and burning / stinging) 06 (± 1) days after onset treatment.

Detailed description

Candicort® presents formulation with agents that act both etiological agent of superficial mycosis, with coverage for dermatophytes and more frequent yeast; as inflammation generated by the infectious process or prior to it, in cases of secondary fungal infection in wet or potentially infected eczema fungal dermatitis (atopic dermatitis, seborrhoeic dermatitis, intertrigo, dyshidrosis, contact dermatitis). The active ingredients ketoconazole and betamethasone act, respectively, on the etiologic agent of the infection and the inflammation generated by the process, and the association of both showed a positive therapeutic response in dermatitis with confirmed secondary infections or potential yeast (analysis carried out in association with sulfate neomycin, aimed to cover bacterial infections together). 160 participants that meet all the inclusion criteria and are not classified in any of the exclusion criteria will be randomly allocated to one of two treatment groups(Candicort® or Baycuten N®) of the study.

Conditions

• Tinea

Interventions

Type	Name	Description
DRUG	Candicort®	Apply on the affected area and around it twice a day
DRUG	Nizoral®	Apply on the affected area and around it twice a day
DRUG	Baycuten N®	Apply on the affected area and around it twice a day
DRUG	Canesten®	Apply on the affected area and around it twice a day

Timeline

• Start date: 2019-06-11
• Primary completion: 2020-01-20
• Completion: 2020-03-24
• First posted: 2015-10-21
• Last updated: 2021-09-20

Locations

9 sites across 1 country: Brazil