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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
125
Apply on the affected area and around it twice a day
Apply on the affected area and around it twice a day
Apply on the affected area and around it twice a day
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
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
Time frame: 6 (±1) days
Percentage change in the total score of signs and symptoms
Evaluate the percentage change in the total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) during the treatment, evaluated in 6 (±1) and 14 (+1) days after onset first stage of treatment in relation to the basal with the treatment group allocated (Candicort® or Baycuten N®). 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.
Time frame: 6 (±1) and 14 (+1) days
Percentage change in the total score of signs and symptoms
Evaluate the percentage change in the total score of signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) in 14 (+1) days after end of the treatment with antifungal isolated (Ketoconazole or Canesten®) in the second stage of treatment. 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.
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Apply on the affected area and around it twice a day
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
Time frame: Up to 1 month
Mycological cure (Negative result for the direct mycological examination)
Assess the proportion of participants who have mycological cure after completion of treatment with antifungal isolated (Ketoconazole or Canesten®) in 14 (+1) days after end of the treatment with antifungal isolated (Ketoconazole or Canesten®) in the second stage of treatment.
Time frame: Up to 1 month
Participants satisfaction regarding the treatment
Assess the satisfaction of participants regarding the treatment using a Visual Analogue Scale (EVA 0 to 100mm) in 6 (±1) and 14 (+1) days after onset first stage of treatment in relation to the basal with the treatment group allocated (Candicort® or Baycuten N®).
Time frame: 6 (±1) days and14 (+1) days
Participants satisfaction regarding the treatment
Assess the satisfaction of participants regarding the treatment using a Visual Analogue Scale (EVA 0 to 100mm) in 14 (+1) days after end of the treatment with antifungal isolated (Ketoconazole or Canesten®) in the second stage of treatment.
Time frame: Up to 1 month