IRCT20191030045275N1 IRCT 2020-02-20 Faculty of Medicine, Tanta University Effect of moxidectin in treatment of scabies Efficacy and Safety of moxidectin versus ivermectin for treatment of human scabies: A randomized clinical trial 2641-08-23 anticipated 100 Pending https://irct.ir/trial/43632 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We used the sealed, opaque sequentially numbered envelopes method for randomization and allocation concealment of patients included in this trial. We used 100 identical, opaque, letter-sized envelopes. We used 2 rolls of household aluminum cooking foil that we cut into 100 sheets (of the same width as and twice the height of the envelope). We prepared 100 envelope-sized sheets of white paper and 100 envelope-sized sheets of single sided carbon paper. We wrote “Treatment A” on 50 paper sheets and “Treatment B” on the other 50 sheets. To prepare 50 Treatment A envelops, we selected one envelope-sized sheet of of Treatment A and placed one sheet of carbon paper on top of the Treatment A allocation paper with the carbon side facing the paper, then we put both papers inside a foil wrapper. Then, the completed insert was placed into a blank envelope with the carbon paper closest to the front of the envelope. Finally, the envelop was sealed and we signed across the seal. We completed all the 50 Treatment A envelops the same way. We prepared 50 Treatment B envelops the same way as Treatment A envelops. Both sets of envelops were combined and we shuffled them thoroughly. Then, using a pen we marked a number on the front of each envelope sequentially from 1 to 100. The carbon paper inside the envelope will transfer this number to the allocation paper inside. Finally, we placed these envelopes into a plastic container, in numerical order, ready for use. Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care 2005;20:187–93, Blinding description: This trial is a single blind study for the participant involved. We will achieve this by making a letter for each medication used and masking the name of the medication. 2 patients diagnosed of having scabies. Intervention 1: Group A (50 patients): Treated by application of topical formulation of moxidectin (Cydectin®) once. Intervention 2: Control group: Group B (50 patients): Treated by application of topical ivermectin (Iverzine®) once per day for 3 successive days. Yes - There is a plan to make this available What will be shared: All IPD that underlie results in a publication and study protocol When: beginning 9 months and ending 36 months following article publication To whom: Researchers whose proposal for the use of data has been approved by an independent review committee identified for this purpose Conditions: for IPD meta-analysis Where to obtain: from the PI How to obtain: A proposal for the use of data to be submitted to the PI, then evaluated by an independent review committee identified for this purpose Comments: