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IRCT20221129056666N1 IRCT 2023-01-24 Tehran University of Medical Sciences Acanthosis Nigricans project A comparative study of efficacy and safety of Glycolic acid 70% peel with topical Tretinoin 0.05% in the treatment of Acanthosis Nigricans patients 2022-12-22 anticipated 30 Complete https://irct.ir/trial/67294 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Since Acanthosis Nigricans lesions develope symmetrically in patients, each patient is treated with topical Tretinoin on one side and with Glycolic acid on the other side, in order to compare the efficacy of these two treatments in each patient with the identical parameters. Since each side of the patient is treated with a different form of treatment, it is impossible to blind the pateints. The specialists that evaluate the outcome of these treatments are however blinded, Randomization description: Simple randomization was used in this study. In this method simple randomization models like tossing a coin , using randomized number tables or computerized methods of randomization is used. In this method each case is allocated in one group ( Tretinoin or Glycolic acid) by tossing a coin for example. Some advantages of this method are unpredictability of treatment used for each side. Implementing of this method is simple. Randomization unit of this study is each case. Randomization software was used for randomization. This software gave us the ability to choose a desired method of randomization among several others. Randomization sequence was created using randomizer software. The sequence was created asking the software to divide 60 cases in to two groups of 30 (0 or 1) equally. Central allocation concealment was used in this study. In this method randomization sequence is available for the manager of the study to apply to the patients accordingly. 3 Acanthosis Nigricans. Intervention 1: Intervention group: Acanthosis Nigricans lesions of one side of the axilla/ groin is treated with Glycolic acid 70% for 4 sessions every 2 weeks. The result of treatment is compared with initial photographies 2 weeks after the last session. Intervention 2: Intervention group: The opposite side of axilla/ groin will be treated with topical Tretinoin cream 0.05% every other night. The result of this treatment is compared with initial photographies after 8 weeks of treatment. Yes - There is a plan to make this available What will be shared: All non recognizable patients information, study design, analytic studies, and the informed consent will be available for publication. When: 6 months after submission To whom: All the scientist, professors who are studying in the field of dermatology, endocrinology, and pharmacology. Conditions: For future studies. Where to obtain: Via emial to the submitted email address. How to obtain: After submission of their request along with their CV and the propose of their request to may email. Comments:
public Rana Samii
Vahdat Eslami Sq.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0174 Raanasamiei@gmail.com Tehran University of Medical Sciences scientific Rana Samii
Vahdat Eslami Sq.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0174 Raanasamiei@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with Acanthosis Nigricans lesions of axilla or neck. Patients with the informed consent for participating in the study. 12 years no limit Both Pregnancy or Lactation Patients with underlying malignancy. Patients with contraindicatons for topical Tretinoin or Glycolic acid. History of treatment of the lesions in the past month. L83 Acanthosis nigricans Treatment - Drugs Treatment - Drugs Intervention group: Acanthosis Nigricans lesions of one side of the axilla/ groin is treated with Glycolic acid 70% for 4 sessions every 2 weeks. The result of treatment is compared with initial photographies 2 weeks after the last session. Intervention group: The opposite side of axilla/ groin will be treated with topical Tretinoin cream 0.05% every other night. The result of this treatment is compared with initial photographies after 8 weeks of treatment. Degree of resolution of Acanthosis Nigricans lesions. Timepoint: 8 weeks after initiation of therapy and 4 treatment sessions. Method of measurement: Comparison with pre treatment photographs. Tehran University of Medical Sciences Approved 2021-12-19 Ethics committee of Tehran University of Medical Sciences school of Medicine Room no. 604 , 6th floor, Tehran University of Medical Sciences main campus, Qods St. , Keshavarz Blvd. , Tehran Tehran Tehran Iran (Islamic Republic of)