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

NCT ID: NCT02582177

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2020-03-24

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Candicort®/ Nizoral®

Candicort® is a cream composed by ketoconazole 20mg/g and betamethasone dipropionate 0,64 mg/g that will be dispensed to 80 participants of this group in the first stage. The cream will be applied in the affected area twice a day for 14 (+1) days. In the second stage Nizoral ® will be dispensed to the same participants. It´s a cream composed by ketoconazole 20mg/g that will be applied in the affected area once a day for 14 days. The total duration of treatment may be 28 (+1) days.

Group Type: EXPERIMENTAL

Candicort®

Intervention Type: DRUG

Apply on the affected area and around it twice a day

Nizoral®

Intervention Type: DRUG

Apply on the affected area and around it twice a day

Baycuten N®/ Canesten®

Baycuten N® is a cream composed by clotrimazole 10mg and dexamethasone acetate 0.443 mg/g that will be dispensed to 80 participants of this group in the first stage. he cream will be applied in the affected area twice a day for 14 (+1) days. In the second stage Canesten ® will be dispensed to the same participants. It´s a cream composed by clotrimazole 10mg that will be applied in the affected area once a day for 14 days.The total duration of treatment may be 28 (+1) days.

Group Type: EXPERIMENTAL

Baycuten N®

Intervention Type: DRUG

Apply on the affected area and around it twice a day

Canesten®

Intervention Type: DRUG

Apply on the affected area and around it twice a day

Interventions

Candicort®

Apply on the affected area and around it twice a day

Intervention Type: DRUG

Nizoral®

Apply on the affected area and around it twice a day

Intervention Type: DRUG

Baycuten N®

Apply on the affected area and around it twice a day

Intervention Type: DRUG

Canesten®

Apply on the affected area and around it twice a day

Intervention Type: DRUG

Other Intervention Names

ketoconazole and betamethasone dipropionate; ketoconazole; clotrimazole and dexamethasone acetate; clotrimazole

Eligibility Criteria

Inclusion Criteria

• Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF);
• Participants with moderate or severe clinical diagnosis of superficial mycoses caused by Candida ssp or following fungal /dermatophytosis infections: inflammatory tinea corporis inflammatory (except face), inflammatory tinea cruris and inflammatory tinea pedis, with confirmation through direct mycological examination. In moderate or severe superficial mycosis that present at least moderate erythema and itching signs and slight peeling according to the evaluation by the four-point category scale (0=absent, 1-mild, 2-moderate, 3-severe);

Exclusion Criteria

• Any observational finding (clinical/ physical evaluation) that is interpreted by the investigator as a risk to the research participant's participation in the clinical trial;
• Known hypersensitivity to the drug components used during the study;
• Use of prohibited drugs and treatment prohibited in the last 90 days;
• Immune impairment, according to investigator assessment;
• Vulvovaginal candidiasis diagnostics, balanopreputial, nail, chronic mucocutaneous or oral;
• Diagnosis of chickenpox, rosacea, herpes simplex or zoster, skin tuberculosis or skin syphilis, systemic fungal infection;
• Participants who, though they have studied diagnosis of fungal infections requiring systemic treatment according to the severity of injury and according to the opinion of the investigator;
• Participants that have skin lesions with clinical signs of bacterial infection;
• Participants who, according to investigator assessment, require systemic antibiotic treatment;
• Participants that are in any treatment , in the opinion of the investigator, may affect the results of the study;
• Participants diagnosed with HIV;
• Participants diagnosed with Diabetes Mellitus;
• Participants with a history of smallpox vaccine reaction;
• Women in gestation period or who are breastfeeding;
• Female participants who are in the reproductive age and do not agree to use acceptable methods of contraception (oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation); except surgically sterile (bilateral oophorectomy or hysterectomy), the menopausal for at least one year and participants who declare to perform sexual practices on a not to reproductive way;
• Participant who participated in clinical in the last twelve months, unless the investigator considers that there may be direct benefit to thereof;
• Participant has some kinship of second degree or bond with employees or employees of Sponsor and Research Center.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

André Vergnanini

Role: PRINCIPAL_INVESTIGATOR

Allergisa Pesquisa Dermato-Cosmetica LTDA

Locations

Centro de Pesquisa Clínica - CPEC / Associação Obras Sociais Irmã Dulce

Salvador, Estado de Bahia, Brazil

Centro de Pesquisa Clínica do IMIP

Recife, Pernambuco, Brazil

Allergisa Pesquisa Dermato Cosmética Ltda.

Campinas, São Paulo, Brazil

Scentryphar Pesquisa Clínica

Campinas, São Paulo, Brazil

Sociedade Campineira de Educação e Instrução - Centro de Pesquisa Clínica São Lucas - PUCCAMP

Campinas, São Paulo, Brazil

Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Centro Integrado de Pesquisa - CIP

São José do Rio Preto, São Paulo, Brazil

CDEC Brasil - Centro de Desenvolvimento em Estudo Clínicos Brasil / AFIP-Associação Fundo de Incentivo à pesquisa)

São Paulo, , Brazil

Centro de Pesquisa Clínica - HSM (Hospital Santa Marcelina)

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

ACH-CND-03(05/15)

Identifier Type: -

Identifier Source: org_study_id