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IRCT20220221054082N1 IRCT 2022-03-17 Shiraz University of Medical Sciences Comparison of the efficacy of Liposomal Amphotericin B gel and Clotrimazole cream in treatment of Tinea versicolor Evaluation of the Effect of Topical Liposomal Amphotericin B Compared to Clotrimazole Cream in the Treatment of Patients with Tinea Versicolor- single -Blind Clinical Trial. 2022-03-07 anticipated 44 Complete https://irct.ir/trial/62115 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed by random allocation software and participants are randomly allocated in the intervention or control group. Randomization of 44 participants in the software is performed by permuted blocks includes eleven four blocks. The output of the software is a table that shows the number of each participant is allocated in the intervention or control group. This software is taken from the site Randomization.com, Blinding description: Because the drugs have different textures ( gel vs. cream ) the study is only investigator blinded. The assessment will be done by another clinician who is blinded to treatment. The patients will be instructed not to discuss the texture or labing of drugs. 3 Tinea Versicolor. Intervention 1: Intervention group: Liposomal Amphotericin B 0.4% gel (Sina Ampholish, Exir, nano sina ) is applied twice daily on the leasions, for 2 weeks. Intervention 2: Control group: Clotrimazole 1% cream ( Najo, Tehran, Iran ) is applied twice daily on the leasions, for 2 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mehdi Ghahartars
Dermatology clinic, Shahid Faghihi hospital, Zand St., Shiraz City
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3235 1087 mghahar@sums.ac Shiraz University of Medical Sciences scientific Mehdi Ghahartars
Dermatology clinic, Shahid Faghihi hospital, Zand St., Shiraz t
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3235 1087 mghahar@sums.ac Shiraz University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of Tinea versicolor and confirmation of diagnosis by Direct smaer Patients of between 15 to 50 years old Less than 10% of body surface area 15 years 50 years Both Pregnancy Lactation History of hypersensitivity to topical Clotrimazole or Liposomal Amphotericin B History of consumption of topical or systemic antifungal medication in the resent 1 month before enrolling study B36.0 Pityriasis versicolor Treatment - Drugs Treatment - Drugs Intervention group: Liposomal Amphotericin B 0.4% gel (Sina Ampholish, Exir, nano sina ) is applied twice daily on the leasions, for 2 weeks. Control group: Clotrimazole 1% cream ( Najo, Tehran, Iran ) is applied twice daily on the leasions, for 2 weeks. Malassezia species positiveity. Timepoint: 0, 14th days. Method of measurement: Direct KOH 10% smear. Scale and hyperpigmentation grade. Timepoint: 0, 14th days. Method of measurement: Physician global assess. Shiraz University of Medical Sciences Approved 2021-02-03 Ethics committee of Shiraz University of Medical sciences Shiraz, university of Medical sciences, Zand Ave Shiraz Fars Iran (Islamic Republic of)