Clinical Trial: Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Fun

Brief Summary: To evaluate the superiority 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.

Detailed Summary:

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).

218 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.


Sponsor: Ache Laboratorios Farmaceuticos S.A.

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Ache Laboratorios Farmaceuticos S.A.

Dates:
Date Received: October 20, 2015
Date Started: August 2017
Date Completion: July 2018
Last Updated: February 14, 2017
Last Verified: February 2017