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IRCT20241028063523N1 IRCT 2024-11-06 Armed forces Hospital PNS Shifa Karachi,Pakistan Comparative efficacy of bifonazole and clotrimazole in the treatment of pitryasis versicolor Comparative efficacy of bifonazole and clotrimazole in the treatment of pitryasis versicolor 2024-11-01 anticipated 60 Complete https://irct.ir/trial/79893 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: All patients presenting in OPD of dermatology Department of PNS Shifa hospital fulfilling inclusion criteria will be included. Patients will be divided into groups using lottery method. 4 Pitryasis versicolor is a chronic cutaneous fungal infection caused by proliferation of lipophilic yeast (malassezia species) in stratum corneum.. Intervention 1: Clinically and mycologically confirmed cases of Pitryasis versicolor shall be divided into 2 groups. Group 1 and Group 2. INTERVENTION GROUP 1 will have 30 patients and they will be recieving bifonazole 1% w/w cream under trade name of BIFOMYK( manufactured by Bioglan pharma. Pakistan ) topical application twice daily for a period of 4 weeks. Response to treatment,disease recurrence and any local or systemic side effects will be checked after 2 and 4 weeks from starting the treatment and they will be followed up for 1 month after stopping the treatment,clinically and with lab investigations by absence of yellow floresence on wood's lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. Patients will be adviced at the time of prescription to apply thin layer of cream that would be absorbed over leisions. Otherwise there is no educational session in this study. The response of treatment shall be entered in pre designed performa to assess the efficacy of 2 therapeutic agents bifonazole and clotrimazole clinically by by absence of yellow floresence on wood's lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. The data will be entered and analyzed by using SPSS statistical package version 21 software . Intervention 2: INTERVENTION GROUP 2 will have 30 patients and they will be recieving clotrimazole 1% w/w cream under trade name of CANESTEN ( manufactured by Bayer pakistan pvt. Ltd ), topical application twice daily for a period of 4 weeks. Response to treatment, disease recurrence and any local or systemuc side effects will be checked after 2 weeks, 4 weeks from starting the treatment and they will be followed up for 1 month after stopping the treatment, clinically and with lab investigation by absence of yellow floresence on woods lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. Patients will be adviced at the time of prescription to apply small amout of cream that would be absorbed over leisions. Otherwise there is no educational session in this study. The response of treatment shall be entered in pre designed performa to assess the efficacy of 2 therapeutic agents bifonazole and clotrimazole clinically by by absence of yellow floresence on wood's lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. The data will be entered and analyzed by using SPSS statistical package version 21 software. Yes - There is a plan to make this available What will be shared: APPENDIX 1: PERFORMA Name, age, gender, address, contact number, weight, height, duration of disease, site group (A,B) INFORMED CONSENT. When: After 6 months RCT, for 4 years. To whom: primary investigator Conditions: All patients in dermatology opd according to operational definition of pitryasis versicolor fullfilling the inclusion criteria. Where to obtain: administration of PNS SHIFA HOSPITAL How to obtain: contact to primary investigator Comments:
public Dr Atiya Rahman
Sailor street, DHA phase ll, PNS Shifa
Karachi Pakistan 75500 +92 21 48506540 sanasaleem20694@gmail.com Armed forces Hospital, PNS Shifa scientific Dr Atiya Rahman
Sailor street DHA phase ll near Kala pul
Karachi Pakistan 75500 +92 21 48506540 sanasaleem20694@gmail.com Armed forces Hospital, PNS shifa Pakistan All patients who will have clinically pitryasis versicolor as per operational definition Patients within range of 18-60 years of age Willing to provide informed consent 18 years 60 years Both Patients with local inflammatory of infectious disease at the site to be treated or who will be allergic to topical medication Previously treated patients Patients delevelop side effects during study B36.0 Pityriasis versicolor Treatment - Drugs Treatment - Drugs Clinically and mycologically confirmed cases of Pitryasis versicolor shall be divided into 2 groups. Group 1 and Group 2. INTERVENTION GROUP 1 will have 30 patients and they will be recieving bifonazole 1% w/w cream under trade name of BIFOMYK( manufactured by Bioglan pharma. Pakistan ) topical application twice daily for a period of 4 weeks. Response to treatment,disease recurrence and any local or systemic side effects will be checked after 2 and 4 weeks from starting the treatment and they will be followed up for 1 month after stopping the treatment,clinically and with lab investigations by absence of yellow floresence on wood's lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. Patients will be adviced at the time of prescription to apply thin layer of cream that would be absorbed over leisions. Otherwise there is no educational session in this study. The response of treatment shall be entered in pre designed performa to assess the efficacy of 2 therapeutic agents bifonazole and clotrimazole clinically by by absence of yellow floresence on wood's lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. The data will be entered and analyzed by using SPSS statistical package version 21 software . INTERVENTION GROUP 2 will have 30 patients and they will be recieving clotrimazole 1% w/w cream under trade name of CANESTEN ( manufactured by Bayer pakistan pvt. Ltd ), topical application twice daily for a period of 4 weeks. Response to treatment, disease recurrence and any local or systemuc side effects will be checked after 2 weeks, 4 weeks from starting the treatment and they will be followed up for 1 month after stopping the treatment, clinically and with lab investigation by absence of yellow floresence on woods lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. Patients will be adviced at the time of prescription to apply small amout of cream that would be absorbed over leisions. Otherwise there is no educational session in this study. The response of treatment shall be entered in pre designed performa to assess the efficacy of 2 therapeutic agents bifonazole and clotrimazole clinically by by absence of yellow floresence on wood's lamp examination and absence of fungal hyphae on microscopy after scrapping mount with potassium hydroxide. The data will be entered and analyzed by using SPSS statistical package version 21 software The primary outcome of the study will focus on mycological cure ( negative microscopy of fungal hyphae by potassium hydroxide mount). Timepoint: Patient will be assessed before intervention, at 2 weeks and 4 weeks after intervention. Method of measurement: Method used to assess mycological cure will be skin scrapping mount with potassium hydroxide( negative for fungal hyphae). The primary outcome of the study will focus on alleviation of physical symptoms such as leision clearence ,erythema, pruritis, desqamation and absence of yellow floresence on wood's lamp examination. Timepoint: Patient will be assessed Before intervention,at 2 weeks and 4 weeks after intervention. Method of measurement: Method used to assess clinical cure will be wood's lamp examination(absence of clinical signs). Tolerability of drugs by monitoring side effects. Timepoint: At 2 weeks and at 4 weeks. Method of measurement: i will measure clinical cure by woods lamp examination(absence of signs) and mycological cure by skin scrapping (negative for fungal hyphae) and side effects (if any). Armed forces Hospital PNS Shifa Karachi,Pakistan Approved 2024-04-05 Ethics Committee of PNS Shifa PNS Shifa Hospital.Sailor street DHA phase ll, near Kala pul. Karachi Sindh Pakistan