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The investigation of the Effect of Melatonin Supplement on Dermatitis

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220331054378N1
Enrollment
80
Registered
2022-04-23
Start date
2022-07-07
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis.

Interventions

Intervention 1: Intervention group: Patients in drug group receive a tablet containing 10 mg of melatonin from Jalinous pharmaceutical company, every night 1 hour before bed for 4 weeks. Patients als

Sponsors

Alborz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: 12 year-old or older patients with dermatitis which has affected at least 5% of whole body Signing the consent form by the patient.

Exclusion criteria

Exclusion criteria: Patients receiving systemic treatment for their dermatitis (exception: antihistamines). Patients receiving sedatives. Patients with history of allergic reactions to Melatonin or other ingredients in tablets. If a patient refuses to continue the study at any time after the study started.

Design outcomes

Primary

MeasureTime frame
Severity of dermatitis. Timepoint: Beginning and the end of the study. Method of measurement: SCORAD index.

Secondary

MeasureTime frame
Quality of Sleep. Timepoint: Beginning and the end of the study. Method of measurement: ISI and ADSS index.;Quality of Life. Timepoint: Beginning and the end of the study. Method of measurement: DLQI index.;Severity of pain. Timepoint: Beginning and the end of the study. Method of measurement: NRS index.;Severity of itching. Timepoint: Beginning and the end of the study. Method of measurement: 12-PSS index.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Daei

Alborz University of Medical Sciences

maryamdaei@yahoo.com+98 26 3256 7175

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026