Comparison of the Effectiveness of topical application of zinc oxide 25% versus zinc oxide 25% plus breastmilk on children under 1 year old with diaper dermatitis ; a randomised controlled trial

Comparison of the effect of breast milk combined with zinc oxide and zinc oxide alone in the treatment of diaper dermatitis

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 42 patients.

After taking the code of ethics, 42 of the infants under one year referred to Bahrami Children's Hospital will be selected after applying the inclusion and exclusion criteria. Random numbers are assigned in a 1:1 ratio to two groups of 21 people A and B. The researchers will record the characteristics in a checklist and will perform an initial evaluation of the diaper dermatitis of the infants participating in the study using the Buckley scale. They receive a score from 0 to 6; a score of 0 indicates the lowest and a score of 6 indicates the highest level of involvement. The first group will be treated with local breast milk every 12 hours along with 25% zinc oxide from Caspian Pharmaceutical Company, every 12 hours, and the second group will be treated only with 25% zinc oxide from Caspian Pharmaceutical Company, every 12 hours. The treatment method adopted in each person will continue for 7 days and the parents/guardian of the child will be asked not to use any other topical medicine during the study. Finally, the recovery process of people in two groups will be compared and evaluated based on other demographic variables and the use of the Buckley scale.

Infants under one year who do not have underlying systemic disease and have not received local treatment before.

In this study, 42 infants under one year will be divided into two equal groups. The control group will be treated with breast milk and topical zinc oxide. The control group will be treated with topical zinc oxide alone.

The severity of the injury, recovery period, complete recovery.

In order to control variables, stratified randomization method will be used. To create a random sequence, age above and below six months and the type of milk as consumption or non-consumption of supplemental milk are considered, and thus four lists include 1- children under six months who drink supplemental milk, 2- children under six months who don't drink supplemental milk, 3- those over 6 months old who drink supplemental milk and 4- those over 6 months old who do not drink supplemental milk will be considered. Then, using random numbers software to determine the order of treatment (topical valve+ zinc oxide and zinc oxide alone) from 2 blocks A and B (instead of each of the treatments and in the form of A B and B) will be used. The study groups are: Group One: Topical Milk+ Zinc Oxide and Group Two: Zinc Oxide alone. Also, randomization tools, random sequence software (Random Allocation Software, Version 2.0) will be accessible from the address. https://random-allocation-software.informer.com/2.0

The present study is one blind, in which the researcher and analyzer of the data will be blind and the patient will not be blind. For this purpose, the type of treatment will be given to the interface based on the blocks made in the sealed envelopes. In order to hide random allocation, non -loose -end envelopes will be used with random sequences. Each of the random sequences created is recorded on a card and the cards are placed in the envelope of the letter respectively. In order to maintain random sequences, the outer surface of the envelopes is done in the same way. Finally, the envelopes will be sealed and placed in a box respectively. At the beginning of the registration of participants, one of the envelopes is opened by the trained person, and the assigned group of the participant is determined. The patient will be aware of the type of treatment, but the researcher and the analyzer will be blind.