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Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis (DaVinci)

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ClinicalTrials.gov Identifier: NCT02582177
Recruitment Status : Recruiting
First Posted : October 21, 2015
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.

Tracking Information
First Submitted Date  ICMJE October 20, 2015
First Posted Date  ICMJE October 21, 2015
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE June 11, 2019
Estimated Primary Completion Date March 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
Percentage change in the total score of signs and symptoms [ Time Frame: 6 (±1) days ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
Percentage change in the total score of signs and symptoms [ Time Frame: 7 days ]
Signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) evaluation by the four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe) in 7 days.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • Percentage change in the total score of signs and symptoms [ Time Frame: 6 (±1) and 14 (+1) days ]
    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.
  • Percentage change in the total score of signs and symptoms [ Time Frame: Up to 1 month ]
    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.
  • Mycological cure (Negative result for the direct mycological examination) [ Time Frame: Up to 1 month ]
    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.
  • Participants satisfaction regarding the treatment [ Time Frame: 6 (±1) days and14 (+1) days ]
    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®).
  • Participants satisfaction regarding the treatment [ Time Frame: Up to 1 month ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
  • Percentage change in the total score of signs and symptoms [ Time Frame: 14 days ]
    Signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) evaluation by the four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe) in 14 days.
  • Percentage change in the total score of signs and symptoms [ Time Frame: 1 month ]
    Signs and symptoms (erythema, maceration, peeling, blistering /papules /pustules, itching and burning/ stinging) evaluation by the four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe) in 1 month.
  • Relief in erythema signs and symptoms [ Time Frame: 7 days ]
    Proportion of participants with erythema signs and symptoms relief evaluated by the four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe) in 7 days
  • Mycological cure [ Time Frame: 1 month ]
    Assess the proportion of participants who have mycological cure after completion of treatment
  • Participants satisfaction regarding the treatment [ Time Frame: Up to 1 month ]
    Assess the satisfaction of participants regarding the treatment on each visit using a Visual Analogue Scale
Current Other Pre-specified Outcome Measures
 (submitted: April 12, 2019)
  • Incidence of adverse events [ Time Frame: 0 day up to 1 month ]
    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®)
  • Variation in vital signs (heart rate) [ Time Frame: 6 (±1) days, 14 (+1) days and up to 1 month ]
    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.
  • Variation in vital signs (blood pressure) [ Time Frame: 6 (±1) days, 14 (+1) days and up to 1 month ]
    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.
  • Rate of participants with any significant variation in Body Mass Index (BMI) [ Time Frame: 6 (±1) days, 14 (+1) days and up to 1 month ]
    Rate of participants with any significant variation in BMI (kg/m2) on each visit, according to investigator assessment.
  • Rate of participants with any significant variation in physical exam [ Time Frame: 6 (±1) days, 14 (+1) days and up to 1 month ]
    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.
  • Rate of participants with any significant variation in complete blood count [ Time Frame: Up to 1 month ]
    Rate of participants with any significant variation in complete blood count on final visit from baseline, according to investigator assessment.
  • Rate of participants with any significant variation in serum sodium and potassium levels [ Time Frame: Up to 1 month ]
    Rate of participants with any significant variation in serum sodium and potassium (mmol/ L) on final visit from baseline, according to investigator assessment.
  • Rate of participants with any significant variation in alkaline phosphatase, glutamic oxaloacetic and glutamic pyruvic transaminases levels [ Time Frame: Up to 1 month ]
    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
  • Rate of participants with any significant variation in bilirubin and fractions levels [ Time Frame: Up to 1 month ]
    Rate of participants with any significant variation in bilirubin and fractions levels (mg/dL) on final visit from baseline, according to investigator assessment.
  • Rate of participants with any significant variation in serum creatinine and urea levels [ Time Frame: Up to 1 month ]
    Rate of participants with any significant variation in serum creatinine and urea (mg/dL) on final visit from baseline, according to investigator assessment.
  • Rate of participants with any significant variation in total proteins and fractions levels [ Time Frame: Up to 1 month ]
    Rate of participants with any significant variation in total proteins and fractions (g/dL) on final visit from baseline, according to investigator assessment.
  • Rate of participants with any significant variation in fasting glycemia level [ Time Frame: Up to 1 month ]
    Rate of participants with any significant variation in fasting glycemia level (mg/dL) on final visit from baseline, according to investigator assessment.
Original Other Pre-specified Outcome Measures
 (submitted: October 20, 2015)
Variation in physical, clinical or laboratory exams ratings [ Time Frame: Up to 1 month ]
Number of participants with adverse events since de baseline visit until 30 days after the end of the treatment; Number of participants with any relevant variation in physical, clinical or laboratory exams from baseline visit until the end of the treatment.
 
Descriptive Information
Brief Title  ICMJE Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tinea
Intervention  ICMJE
  • Drug: Candicort®
    Apply on the affected area and around it twice a day
    Other Name: ketoconazole and betamethasone dipropionate
  • Drug: Nizoral®
    Apply on the affected area and around it twice a day
    Other Name: ketoconazole
  • Drug: Baycuten N®
    Apply on the affected area and around it twice a day
    Other Name: clotrimazole and dexamethasone acetate
  • Drug: Canesten®
    Apply on the affected area and around it twice a day
    Other Name: clotrimazole
Study Arms  ICMJE
  • Experimental: Candicort®/ Nizoral®
    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.
    Interventions:
    • Drug: Candicort®
    • Drug: Nizoral®
  • Experimental: Baycuten N®/ Canesten®
    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.
    Interventions:
    • Drug: Baycuten N®
    • Drug: Canesten®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 25, 2017)
160
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2015)
218
Estimated Study Completion Date  ICMJE May 12, 2021
Estimated Primary Completion Date March 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elisangela Rorato +55 11 2608-6130 elisangela.rorato@ache.com.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02582177
Other Study ID Numbers  ICMJE ACH-CND-03(05/15)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ache Laboratorios Farmaceuticos S.A.
Study Sponsor  ICMJE Ache Laboratorios Farmaceuticos S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: André Vergnanini Allergisa Pesquisa Dermato-Cosmetica LTDA
PRS Account Ache Laboratorios Farmaceuticos S.A.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP