Ignite Creation Date:
2024-05-06 @ 7:43 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02582177
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2015-10-20
Brief Title:
Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis
Sponsor:
Ache Laboratorios Farmaceuticos SA
Organization:
Ache Laboratorios Farmaceuticos SA
Study Overview
Official Title:
Phase 3 Study Randomized Double-blind Parallel to Evaluate Ketoconazole and Betamethasone DipropionateCandicort Compared to Clotrimazole and Dexamethasone AcetateBaycuten N in Relief of Fungal InfectionsDermatophytosis Symptoms
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DaVinci
Brief Summary:
To evaluate the no-inferiority of the ketoconazole20mgg and betamethasone dipropionate 064 mgg association Candicort cream versus clotrimazole 10mg and dexamethasone acetate 0443 mgg 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 groupsCandicort or Baycuten N of the study
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 groupsCandicort or Baycuten N of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None