Dermatophytoses
Conditions
Brief summary
To compare the efficacy of oxiconazole 1 % cream and clotrimazole cream for treatment of dermatophytosis
Detailed description
Following approval from the hospital ethical committee, informed consent will be obtained from all patients, with basic information including name, age, gender, baseline clinical score, and location of dermatophytosis noted. A total of 164 patients will be evenly divided into two groups, each comprising 82 patients, utilizing a lottery method. In Group A, 1% oxiconazole cream will be applied once daily on skin lesions, while in Group B, 1% clotrimazole cream will be applied twice daily on the affected skin area. Tab. certirizine 10mg will be taken by patients of both groups at night for itching. The treatment will be continued for 1 month, and patients will do follow up visit at 2nd and 4th week from baseline. The clinical score will be assessed and photographs will be taken at each visit. Clinical assessment score will be will be made on the parameters of erythema, pruritus, and scaling, ranging from 0 (absent) to 3 (severe) for each parameter, with a maximum total score of 9.
Interventions
DRUGOxiconazole Nitrate Cream
Oxiconazole 1 % cream will be applied on dermatophytosis lesions
Clotrimazole cream will be applied to clotrimazole group on dermatophytosis lesions
Sponsors
Shalamar Institute of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years and above * Patients diagnosed with dermatophytosis per operational definition, involving less than 10% body surface area, that does not necessitate oral antifungal treatment (as assessed by the researcher). * Both males and females.
Exclusion criteria
* History of hypersensitivity to azole drugs or vehicle ingredients. * Use of any antifungal agents within past four weeks. * Use of topical corticoseroids within past two weeks. * Pregnant and lactating mothers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy in terms of clearance of lesions , pruritis and scaling | 6 months | Efficacy as complete clinical cure at the conclusion of the treatment period. Complete clinical cure will be considered 0 score on Clinical Assessment Score (CAS). Clinical Assessment Score: It will be assessed on the parameters of erythema, pruritus, and scaling, ranging from 0 (absent) to 3 (severe) for each parameter, with a maximum total score of 9. |
Countries
Pakistan
Outcome results
None listed