The investigation of the effect of Melatonin Supplement on Dermatitis Severity in Patients: a randomized, double-blinded, placebo-controlled clinical trial

Determining the effect of melatonin supplementation on the severity of symptoms and pain intensity, itching, sleep quality and quality of life in dermatitis patients.

Clinical trial with control group, parallel groups, double blind, randomized, phase 3 on 80 patients. Permuted Block is used for randomization.

After admitting the patient in Karaj Imam Ali Hospital by a clinician, the patient (if included) is randomly assigned to one of the study groups. Demographic information, underlying diseases, medications and patient habits will be recorded. The patient will be visited at the beginning and end of the study. Dermatitis severity will assessed with SCORAD index, patient s sleep quality with ISI and ADSS index, quality of life with DLQI, pain with NRS index and pruritus with 12-PSS index at the beginning and end of the study.

Inclusion criteria: 12 years of age or older patients with dermatitis and at least 5% whole body involvement and informed written consent. Exclusion criteria: Patients who receive systemic treatment for their dermatitis (exception: antihistamines), use sedatives, have a history of allergic reactions to Melatonin or other ingredients in tablets. If a patient does not want to continue the study at any time after the study has started.

Patients in drug group receive a tablet containing 10 mg of melatonin from Jalinous pharmaceutical company, at night, 1 hour before bed for 4 weeks. The placebo group receives an ineffective pill with similar appearance to melatonin tablet, for 4 weeks, at night 1 hour before bedtime. In both groups, patients receive routine and main dermatitis treatment regimen.

Improvement of severity of symptoms, pain intensity, itching, sleep quality and quality of life in dermatitis patients.

Being in melatonin tablet or placebo group is based on Permuted Block Randomization. Individual stratified randomization is performed. Random blocks are generated by computer statistical software. Patients enter blocks including four and receive melatonin tablet or placebo in a randomized manner. Allocation concealment is carried out. Physician, patient and first researcher are not aware of patients' group.

The physician, the first researcher and patient are unaware of the melatonin or placebo allocation. The second researcher is not blinded. The second researcher repackages tablets of melatonin and placebo without name but with codes and gives them to the first researcher. The second researcher has no intervention in allocation of patients and outcome assessment. The first researcher receives packages containing melatonin or placebo and delivers them to patients. The first researcher is involved in outcome assessment and is unaware that patients receive melatonin or placebo.

Data sharing is possible if asked

After article acceptance

Researchers working in scientific institutes and universities

The data is only available for viewing.

m.daei@abzums.ac.ir

Up to one month after the announcement of the need