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Completed

NCT Number: NCT02582177

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

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.

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Key information

Conditions

Tinea Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Dermatomycoses Infections Inflammation Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Pesquisa Clínica - CPEC / Associação Obras Sociais Irmã Dulce, Salvador, Estado de Bahia, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Candicort®

Drug

Apply on the affected area and around it twice a day

Other names: ketoconazole and betamethasone dipropionate

Nizoral®

Drug

Apply on the affected area and around it twice a day

Other names: ketoconazole

Baycuten N®

Drug

Apply on the affected area and around it twice a day

Other names: clotrimazole and dexamethasone acetate

Canesten®

Drug

Apply on the affected area and around it twice a day

Other names: clotrimazole

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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®).

  5. 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.

Other outcomes

  1. 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®)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Ache Laboratorios Farmaceuticos S.A.

Industry

Registry information

Official study 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.

Acronym: DaVinci

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 21, 2015
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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