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IRCT20241028063523N4 IRCT 2024-11-27 Armed forces Hospital PNS Shifa Karachi,Pakistan. Comparative efficacy of combined treatment with ketoconazole 2% cream and adapalene 0.1% gel versus ketoconazole 2% cream monotherapy in pityriasis versicolor. Comparative efficacy of combined treatment with ketoconazole 2% cream and adapalene 0.1% gel versus ketoconazole 2% cream monotherapy in pityriasis versicolor. 2024-11-19 anticipated 60 Complete https://irct.ir/trial/80249 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 Pityriasis versicolor is a common yeast infection of the skin, in which flaky discolored patches appear on the chest and back. The term pityriasis is used to describe skin conditions in which the scale appears similar to bran. The multiple colors of pityriasis versicolor give rise to the second part of the name, versicolor. Pityriasis versicolor is sometimes called tinea versicolor, although the term tinea should strictly be used for dermatophyte fungus infections.. Intervention 1: Confirmed cases of Pityriasis versicolor will be divided into 2 groups. Group 1 and Group 2. (Group A) will receive a combination therapy consisting of Adapco Gel 0.1% (Adapalene) and Conaz Cream 2% (Ketoconazole). Participants in this group will apply both treatments once daily for a duration of two weeks. Conaz Cream 2%, an antifungal agent, works by inhibiting ergosterol synthesis, effectively targeting the Malassezia species responsible for Pityriasis Versicolor. Adapco Gel 0.1%, a retinoid, reduces hyper keratinization and promotes skin renewal while enhancing the antifungal's penetration, creating a synergistic therapeutic effect. The efficacy of this combination therapy will be evaluated through improvement in clinical signs, absence of yellow fluorescence under Wood's lamp, and negative results on KOH testing at two-week and four-week follow-ups. Intervention 2: Group B will receive Conaz Cream 2% (Ketoconazole) as monotherapy. Participants will apply the cream once daily for a duration of two weeks, focusing on the affected areas. As the standard treatment, Conaz Cream 2% targets fungal growth and is effective in managing symptoms of Pityriasis Versicolor. Efficacy will be assessed using the same parameters as the intervention group: improvement in clinical signs, absence of yellow fluorescence under Wood's lamp, and negative KOH test results. Comparison with the intervention group will determine if the addition of Adapco Gel 0.1% offers significant advantages. Yes - There is a plan to make this available What will be shared: APPENDIX 1: PROFORMA EFFICACY OF COMBINED TREATMENT WITH KETOCONAZOLE 2% CREAM AND ADAPALENE 0.1% GEL VS. KETOCONAZOLE 2% CREAM MONOTHERAPY IN PITYRIASIS VERSICOLOR – A RANDOMIZED CONTROLLED TRIAL Name: _______________________________ Age (years): ___________________ Gender: Male/Female Height (m): ___________________________ Weight (kg): ____________________ BMI (kg/m2): __________________________ Duration (weeks): _______________ Size of lesion (cm): _______________ Group: A(COMBINATION) Group: B (MONOTHERAPY) SIDE EFFECTS IF ANY: _______________________ OUTCOME VARIABLE: EFFICACY: YES/NO When: After 6 months RCT, for 4 years. To whom: primary investigator. Conditions: All patients in dermatology OPD according to operational definition of pityriasis versicolor fulfilling 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 hospital, near Kala pul.
Karachi Pakistan 07557 +92 21 48506540 Sunainap7@gmail.com Armed forces Hospital, PNS Shifa. scientific Dr Atiya Rahman
Sailor street, DHA phase ll, PNS Shifa hospital, near Kala pul.
Karachi Pakistan 07557 +92 21 48506540 Sunainap7@gmail.com Armed forces Hospital PNS Shifa Karachi, Pakistan. Pakistan Diagnosed cases of pityriasis versicolor lesions (as per operational definition) with disease involving total body surface area. Patients within the age range of 18–60 years of either sex Willing to provide informed consent. 18 years 60 years Both Patients with known hypersensitivity/allergy to Ketoconazole or Adapalene, patients with concurrent diseases (hyperthyroidism or hyperhidrosis) and pregnant/ lactating mothers, previous treatment taken 8 weeks back will be excluded from the study. B36.0 Pityriasis versicolor Treatment - Drugs Treatment - Drugs Confirmed cases of Pityriasis versicolor will be divided into 2 groups. Group 1 and Group 2. (Group A) will receive a combination therapy consisting of Adapco Gel 0.1% (Adapalene) and Conaz Cream 2% (Ketoconazole). Participants in this group will apply both treatments once daily for a duration of two weeks. Conaz Cream 2%, an antifungal agent, works by inhibiting ergosterol synthesis, effectively targeting the Malassezia species responsible for Pityriasis Versicolor. Adapco Gel 0.1%, a retinoid, reduces hyper keratinization and promotes skin renewal while enhancing the antifungal's penetration, creating a synergistic therapeutic effect. The efficacy of this combination therapy will be evaluated through improvement in clinical signs, absence of yellow fluorescence under Wood's lamp, and negative results on KOH testing at two-week and four-week follow-ups. Group B will receive Conaz Cream 2% (Ketoconazole) as monotherapy. Participants will apply the cream once daily for a duration of two weeks, focusing on the affected areas. As the standard treatment, Conaz Cream 2% targets fungal growth and is effective in managing symptoms of Pityriasis Versicolor. Efficacy will be assessed using the same parameters as the intervention group: improvement in clinical signs, absence of yellow fluorescence under Wood's lamp, and negative KOH test results. Comparison with the intervention group will determine if the addition of Adapco Gel 0.1% offers significant advantages. Clinical improvement: More than 50% improvement in clinical signs of Pityriasis Versicolor. Negative fluorescence: Absence of yellow fluorescence on Wood's lamp examination of lesions. Negative KOH test: Absence of fungal elements in skin scrapings after four weeks of treatment. Timepoint: Patient will be assessed, before intervention at 2 weeks, and 4 weeks after intervention. Method of measurement: Clinical Examination: Observation of improvement in clinical signs such as scaling, pigmentation (hyperpigmentation or hypopigmentation), and lesion appearance. A more than 50% reduction in clinical signs is considered effective. Wood's Lamp Examination: Use of Wood's lamp to detect yellow fluorescence characteristic of Pityriasis Versicolor lesions. Negative fluorescence after treatment indicates efficacy. KOH Examination: Skin scrapings from lesions examined under a microscope after applying potassium hydroxide (KOH) to identify fungal elements. Absence of fungal elements after treatment confirms effectiveness. Photographic Evidence: Photographs of lesions taken before and after treatment to document changes. Demographic and Baseline Data: Collection of patient details, including age, sex, BMI, duration of the disease, and lesion size, which could influence treatment outcomes. Follow-Up Schedule: Re-evaluation at two weeks and four weeks post-treatment initiation using the above assessments. Side Effects: Monitoring and documenting adverse effects related to the treatments, such as skin irritation, dryness, or allergic reactions. Timepoint: At 2 weeks and at 4 weeks. Method of measurement: Patient Self-Report: Patients will be asked to report any discomfort, such as irritation, dryness, or allergic reactions during follow-up visits. Documented using a standardized proforma. Clinical Observation: inspect the treated areas for signs of adverse reactions, such as redness, peeling, or swelling. Armed forces Hospital PNS Shifa Karachi,Pakistan. Approved 2024-11-18 Ethical committee PNS SHIFA PNS Shifa Hospital, Sailor street DHA phase ll, near Kala pul. Karachi Sindh Pakistan