A Phase 3 interventional study of Candicort® and Nizoral® in Tinea, sponsored by Ache Laboratorios Farmaceuticos S.A.. Completed at 9 sites in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-09-20.
Sponsored by Ache Laboratorios Farmaceuticos S.A. · Phase 3, Interventional, and Treatment
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.
39 studies on the registry are indexed under Tinea; 8 are open to participants now.
This study's enrollment of 125 is above the median of 64 across 33 interventional studies indexed under Tinea.
Browse Tinea studies →Ache Laboratorios Farmaceuticos S.A. is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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® 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®
Apply on the affected area and around it twice a day
Also known as: ketoconazole and betamethasone dipropionate
Apply on the affected area and around it twice a day
Also known as: ketoconazole
Apply on the affected area and around it twice a day
Also known as: clotrimazole and dexamethasone acetate
Apply on the affected area and around it twice a day
Also known as: clotrimazole
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.
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
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®)
Time frame: 0 day up to 1 month
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.
Time frame: 6 (±1) days, 14 (+1) days and up to 1 month
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.
Time frame: 6 (±1) days, 14 (+1) days and up to 1 month
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.
Time frame: 6 (±1) days, 14 (+1) days and up to 1 month
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.
Time frame: 6 (±1) days, 14 (+1) days and up to 1 month
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.
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
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
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
Ran from Jun 2019 to primary completion in Jan 2020, 7 months.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ketoconazole · Dexamethasone · Clotrimazole
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