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

Tinea Clinical Trial

— DaVinci  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582177
• Other study ID #: ACH-CND-03(05/15)
• Status: Completed
• Phase: Phase 3
• Start date: June 11, 2019
• Est. completion date: March 24, 2020

Study information

• Verified date: September 2021
• Source: Ache Laboratorios Farmaceuticos S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 24, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Mycoses
• Tinea

Intervention

Drug:
• Candicort®
Apply on the affected area and around it twice a day
• Nizoral®
Apply on the affected area and around it twice a day
• Baycuten N®
Apply on the affected area and around it twice a day
• Canesten®
Apply on the affected area and around it twice a day

Locations

Country	Name	City	State
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 Pesquisa Clínica do IMIP	Recife	Pernambuco
Brazil	Centro de Pesquisa Clínica - CPEC / Associação Obras Sociais Irmã Dulce	Salvador	Bahia
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

Sponsors (1)

Lead Sponsor	Collaborator
Ache Laboratorios Farmaceuticos S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events	Number of participants with adverse events since first dose of treatment (Candicort® or Baycuten N®) until 30 (+7) days after the end of the second phase of treatment with antifungal isolated (Nizoral® or Canesten®)	0 day up to 1 month
Other	Variation in vital signs (heart rate)	Variation in heart rate (beats per minute) on each visit from baseline. In this study the physiological parameter for heart rate is 50-100 bpm.	6 (±1) days, 14 (+1) days and up to 1 month
Other	Variation in vital signs (blood pressure)	Variation in blood pressure (mmHg) on each visit from baseline. In this study the physiological parameters for systolic blood pressure is = 139 mmHg and diastolic blood pressure is = 89 mmHg.	6 (±1) days, 14 (+1) days and up to 1 month
Other	Rate of participants with any significant variation in Body Mass Index (BMI)	Rate of participants with any significant variation in BMI (kg/m2) on each visit, according to investigator assessment.	6 (±1) days, 14 (+1) days and up to 1 month
Other	Rate of participants with any significant variation in physical exam	Rate of participants with any significant variation in inspect skin, oropharyngeal system, skeletal muscle system, respiratory system, cardiovascular system, digestive system, genitourinary system, neurological system on each visit, according to investigator assessment.	6 (±1) days, 14 (+1) days and up to 1 month
Other	Rate of participants with any significant variation in complete blood count	Rate of participants with any significant variation in complete blood count on final visit from baseline, according to investigator assessment.	Up to 1 month
Other	Rate of participants with any significant variation in serum sodium and potassium levels	Rate of participants with any significant variation in serum sodium and potassium (mmol/ L) on final visit from baseline, according to investigator assessment.	Up to 1 month
Other	Rate of participants with any significant variation in alkaline phosphatase, glutamic oxaloacetic and glutamic pyruvic transaminases levels	Rate of participants with any significant variation in alkaline phosphatase, glutamic oxaloacetic and glutamic pyruvic transaminases (U/L) on final visit from baseline, according to investigator assessment	Up to 1 month
Other	Rate of participants with any significant variation in bilirubin and fractions levels	Rate of participants with any significant variation in bilirubin and fractions levels (mg/dL) on final visit from baseline, according to investigator assessment.	Up to 1 month
Other	Rate of participants with any significant variation in serum creatinine and urea levels	Rate of participants with any significant variation in serum creatinine and urea (mg/dL) on final visit from baseline, according to investigator assessment.	Up to 1 month
Other	Rate of participants with any significant variation in total proteins and fractions levels	Rate of participants with any significant variation in total proteins and fractions (g/dL) on final visit from baseline, according to investigator assessment.	Up to 1 month
Other	Rate of participants with any significant variation in fasting glycemia level	Rate of participants with any significant variation in fasting glycemia level (mg/dL) on final visit from baseline, according to investigator assessment.	Up to 1 month
Primary	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	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.	6 (±1) and 14 (+1) days
Secondary	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.	Up to 1 month
Secondary	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.	Up to 1 month
Secondary	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®).	6 (±1) days and14 (+1) days
Secondary	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.	Up to 1 month