Clinical trial NCT02582177: Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea
Keywords: Fungal infection
Skin infection
Dermatophytoses
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage change in the total score of signs and symptoms
timeFrame: 6 (±1) days
Secondary outcomes:
measure: Percentage change in the total score of signs and symptoms
timeFrame: 6 (±1) and 14 (+1) days
measure: Percentage change in the total score of signs and symptoms
timeFrame: Up to 1 month
measure: Mycological cure (Negative result for the direct mycological examination)
timeFrame: Up to 1 month
measure: Participants satisfaction regarding the treatment
timeFrame: 6 (±1) days and14 (+1) days
measure: Participants satisfaction regarding the treatment
timeFrame: Up to 1 month
Other outcomes:
measure: Incidence of adverse events
timeFrame: 0 day up to 1 month
measure: Variation in vital signs (heart rate)
timeFrame: 6 (±1) days, 14 (+1) days and up to 1 month
measure: Variation in vital signs (blood pressure)
timeFrame: 6 (±1) days, 14 (+1) days and up to 1 month
measure: Rate of participants with any significant variation in Body Mass Index (BMI)
timeFrame: 6 (±1) days, 14 (+1) days and up to 1 month
measure: Rate of participants with any significant variation in physical exam
timeFrame: 6 (±1) days, 14 (+1) days and up to 1 month
measure: Rate of participants with any significant variation in complete blood count
timeFrame: Up to 1 month
measure: Rate of participants with any significant variation in serum sodium and potassium levels
timeFrame: Up to 1 month
measure: Rate of participants with any significant variation in alkaline phosphatase, glutamic oxaloacetic and glutamic pyruvic transaminases levels
timeFrame: Up to 1 month
measure: Rate of participants with any significant variation in bilirubin and fractions levels
timeFrame: Up to 1 month
measure: Rate of participants with any significant variation in serum creatinine and urea levels
timeFrame: Up to 1 month
measure: Rate of participants with any significant variation in total proteins and fractions levels
timeFrame: Up to 1 month
measure: Rate of participants with any significant variation in fasting glycemia level
timeFrame: Up to 1 month
Locations:
city: Salvador
country: Brazil
facility: Centro de Pesquisa Clínica - CPEC / Associação Obras Sociais Irmã Dulce
state: Bahia
city: Recife
country: Brazil
facility: Centro de Pesquisa Clínica do IMIP
state: Pernambuco
city: Campinas
country: Brazil
facility: Allergisa Pesquisa Dermato Cosmética Ltda.
state: São Paulo
city: Campinas
country: Brazil
facility: Scentryphar Pesquisa Clínica
state: São Paulo
city: Campinas
country: Brazil
facility: Sociedade Campineira de Educação e Instrução - Centro de Pesquisa Clínica São Lucas - PUCCAMP
state: São Paulo
city: Santo André
country: Brazil
facility: Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC
state: São Paulo
city: São José Do Rio Preto
country: Brazil
facility: Centro Integrado de Pesquisa - CIP
state: São Paulo
city: São Paulo
country: Brazil
facility: CDEC Brasil - Centro de Desenvolvimento em Estudo Clínicos Brasil / AFIP-Associação Fundo de Incentivo à pesquisa)
city: São Paulo
country: Brazil
facility: Centro de Pesquisa Clínica - HSM (Hospital Santa Marcelina)
Study officials:
affiliation: Allergisa Pesquisa Dermato-Cosmetica LTDA
name: André Vergnanini
role: PRINCIPAL_INVESTIGATOR
References: