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

NCT02582177 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2021-09-20

No results posted yet for this study

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.

Conditions

  • Tinea

Interventions

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

Sponsors & Collaborators

  • Ache Laboratorios Farmaceuticos S.A.

    lead INDUSTRY

Principal Investigators

  • André Vergnanini · Allergisa Pesquisa Dermato-Cosmetica LTDA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2020-01-20
Completion
2020-03-24

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582177 on ClinicalTrials.gov