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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02582177
Recruitment Status : Not yet recruiting
First Posted : October 21, 2015
Last Update Posted : April 9, 2018
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.

Brief Summary:
To evaluate the no-inferiority of the ketoconazole20mg/g and betamethasone dipropionate 0.64 mg/g association (Candicort®) cream or ointment 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.

Condition or disease Intervention/treatment Phase
Tinea Drug: Ketoconazole + betamethasone dipropionate Drug: Clotrimazole + Dexamethasone acetate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study, Randomized, Open, Parallel to Evaluate Ketoconazole and Betamethasone Dipropionate(Candicort®) Compared to Clotrimazole and Dexamethasone Acetate(Baycuten N®) in Relief of Fungal Infections/Dermatophytosis Symptoms.
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : February 1, 2019

Arm Intervention/treatment
Experimental: Candicort®
Ketoconazole + betamethasone dipropionate
Drug: Ketoconazole + betamethasone dipropionate
Apply on the affected area and around it twice a day
Other Name: Candicort

Active Comparator: Baycuten N®
Clotrimazole + Dexamethasone acetate
Drug: Clotrimazole + Dexamethasone acetate
Apply on the affected area and around it twice a day
Other Name: Baycuten N

Primary Outcome Measures :
  1. Percentage change in the total score of signs and symptoms [ Time Frame: 6 (±1) 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 6 (±1) days after onset first phase of treatment in relation to the basal.

Secondary Outcome Measures :
  1. Percentage change in the total score of signs and symptoms [ Time Frame: 6 (±1) and 14 (+1) 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) during first phase of treatment in 6 (±1) and 14 (+1) days with the treatment group allocated (Candicort® or Baycuten N®) in the first phase of treatment

  2. Percentage change in the total score of signs and symptoms [ Time Frame: 28 (+1) 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 (+1) days after onset treatment with antifungal isolated (Ketoconazole or Canesten®) in the second phase of treatment.

  3. Mycological cure (Negative result for the direct mycological examination) [ Time Frame: 28 (+1) days ]
    Assess the proportion of participants who have mycological cure 14 (+2) days after completion of treatment with antifungal isolated (Ketoconazole or Canesten®) during 14 (+1) days in the second phase of treatment.

  4. 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

Other Outcome Measures:
  1. Incidence of adverse events andvariation in physical, clinical or laboratory exams ratings [ Time Frame: 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 ((Ketoconazole or Canesten®); Number of participants with any variation in vital signs on each visit from baseline. Number of participants with any variation in significant variation in physical and clinical exames on each visit.

    Number of participants with any variation in laboratory exams on final visit from baseline.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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: Tinea corporis inflammatory (except face), Tinea cruris and Tinea inflammatory 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 evaluation / physical) that is interpreted by the medical researcher 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.

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Responsible Party: Ache Laboratorios Farmaceuticos S.A. Identifier: NCT02582177     History of Changes
Other Study ID Numbers: ACH-CND-03(05/15)
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
Fungal infection
Skin infection

Additional relevant MeSH terms:
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Skin Diseases, Infectious
Skin Diseases
Dexamethasone acetate
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents