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

NCT02582177 | Completed Phase 3

• 1 other identifier: ACH-CND-03(05/15)
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 9

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.

Conditions

Tinea

Keywords

Fungal infection; Skin infection; Dermatophytoses

Outcome Measures

Primary Outcomes (1)

• Percentage change in the total score of signs and symptoms

  Percentage change in the total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) in 6 (±1) days after onset first stage of treatment in relation to the basal. The total score will be established by the sum of individual scores of the signs and symptoms assessed by the four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe), ranging from 0 to 18 points. The percentage change in the total score of signs and symptoms will be calculated by the following expression: VTSS(%) = \[(TSS0 -TSS6)/ TSS0\]\*100 TSS0: total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) in 0 day. TSS6: total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) in 6 (±1) days after onset first stage of treatment

  6 (±1) days

Secondary Outcomes (5)

• Percentage change in the total score of signs and symptoms

  6 (±1) and 14 (+1) days

• Percentage change in the total score of signs and symptoms

  Up to 1 month

• Mycological cure (Negative result for the direct mycological examination)

  Up to 1 month

• Participants satisfaction regarding the treatment

  6 (±1) days and14 (+1) days

• Participants satisfaction regarding the treatment

  Up to 1 month

Other Outcomes (12)

• Incidence of adverse events

  0 day up to 1 month

• Variation in vital signs (heart rate)

  6 (±1) days, 14 (+1) days and up to 1 month

• Variation in vital signs (blood pressure)

  6 (±1) days, 14 (+1) days and up to 1 month

Study Arms (2)

Candicort®/ Nizoral®

EXPERIMENTAL

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.

Drug: Candicort®; Drug: Nizoral®

Baycuten N®/ Canesten®

EXPERIMENTAL

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.

Drug: Baycuten N®; Drug: Canesten®

Interventions

Candicort® DRUG

Apply on the affected area and around it twice a day

Also known as: ketoconazole and betamethasone dipropionate

Candicort®/ Nizoral®

Nizoral® DRUG

Apply on the affected area and around it twice a day

Also known as: ketoconazole

Candicort®/ Nizoral®

Baycuten N® DRUG

Apply on the affected area and around it twice a day

Also known as: clotrimazole and dexamethasone acetate

Baycuten N®/ Canesten®

Canesten® DRUG

Apply on the affected area and around it twice a day

Also known as: clotrimazole

Baycuten N®/ Canesten®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (9)

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

Salvador, Estado de Bahia, Brazil

Location

Centro de Pesquisa Clínica do IMIP

Recife, Pernambuco, Brazil

Location

Allergisa Pesquisa Dermato Cosmética Ltda.

Campinas, São Paulo, Brazil

Location

Scentryphar Pesquisa Clínica

Campinas, São Paulo, Brazil

Location

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

Campinas, São Paulo, Brazil

Location

Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Location

Centro Integrado de Pesquisa - CIP

São José do Rio Preto, São Paulo, Brazil

Location

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

São Paulo, Brazil

Location

Centro de Pesquisa Clínica - HSM (Hospital Santa Marcelina)

São Paulo, Brazil

Location

MeSH Terms

Conditions

Tinea; Mycoses; Cellulitis

Interventions

Ketoconazole; betamethasone-17,21-dipropionate; Calcium Dobesilate; Clotrimazole; dexamethasone acetate

Condition Hierarchy (Ancestors)

Dermatomycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Suppuration; Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Imidazoles; Azoles

Study Officials

• André Vergnanini

  Allergisa Pesquisa Dermato-Cosmetica LTDA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 21, 2015
• Study Start: June 11, 2019
• Primary Completion: January 20, 2020
• Study Completion: March 24, 2020
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

BR (9)