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IRCT20250923067342N1 IRCT 2025-11-18 Iran University of Medical Sciences Evaluation of the effect of Mamogol cream on mild to moderate hand irritant contact dermatitis Evaluation of the effect of Mamogol cream in comparison with Hydrocortisone 1% on mild to moderate hand irritant contact dermatitis, clinical trial 2025-10-17 anticipated 90 Complete https://irct.ir/trial/86404 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining informed consent, patients are randomly assigned to two groups. Randomization is performed using the Random Allocation Software through a block randomization method with randomly generated blocks. To ensure allocation concealment, sealed envelopes are employed: the patient’s identification number is written on the outside of each envelope, while the assigned study group is indicated inside. Each patient opens his or her respective envelope to determine group allocation, Blinding description: The creams will be dispensed in identical, unlabeled containers. 3 mild to moderate Irritant contact dermatitis of hand. Intervention 1: Intervention group: Patients apply Mamogel cream (produced by Goldaroo Pharmaceutical Company) topically to the affected area twice daily for two consecutive weeks. Intervention 2: Control group: Patients apply 1% hydrocortisone ointment to the affected area twice daily for two weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public zahra sadat akhlaghi
Behesht
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5563 9667 dr.zs.akhlaghi@iran.ir Iran University of Medical Sciences scientific Zahra sadat akhlaghi
Behesht
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5563 9667 dr.zs.akhlaghi@iran.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Individuals aged 12–65 years of both sexes, diagnosed with mild to moderate irritant contact dermatitis of the hands by a dermatologist, based on the Hand Eczema Severity Index (HECSI) classification system Patients who have not received any medical treatment for hand dermatitis for at least one week prior to enrollment, and who have not used topical corticosteroids during the past week. Patients evaluated according to Traditional Persian Medicine principles, with a comprehensive TPM history obtained at the outset of the study. Provision of written informed consent. 12 years 65 years Both Patients reporting a history of allergy to Althaea officinalis Patients currently receiving other corticosteroid medications, antibiotics, or skin‑drying agents such as isotretinoin (Roaccutane). Patients unwilling to discontinue use of these medications. Patients with very severe hand dermatitis, with a HECSI (Hand Eczema Severity Index) score above 117, according to the classification system Patients with uncontrolled systemic cardiovascular, respiratory, hematologic, urinary, autoimmune, infectious diseases, or diabetes mellitus. Pregnant or breastfeeding women. L24 Irritant contact dermatitis Treatment - Drugs Treatment - Drugs Intervention group: Patients apply Mamogel cream (produced by Goldaroo Pharmaceutical Company) topically to the affected area twice daily for two consecutive weeks Control group: Patients apply 1% hydrocortisone ointment to the affected area twice daily for two weeks. Severity of dermatitis symptoms. Timepoint: Effect of Mamogel cream after two weeks of use, and assessment of disease recurrence two weeks after discontinuation of the medication. Method of measurement: Severity of dermatitis symptoms is assessed based on patient self‑report using the standard Hand Eczema Severity Index (HECSI) questionnaire. Incidence and type of adverse effects observed during treatment. Timepoint: Assessments will be performed at baseline, after completion of treatment, and two weeks after treatment discontinuation. Method of measurement: Based on patient self‑report and according to the CTCAE questionnaire. Quality of life. Timepoint: Assessments will be performed at baseline, after completion of treatment, and two weeks after treatment discontinuation. Method of measurement: Based on patient self‑report by completing the standard DLQI questionnaire. Recurrence of symptoms two weeks after completion of treatment. Timepoint: two weeks after completion of treatment. Method of measurement: Based on patient self‑report by completing the standard HECSI questionnaire. Iran University of Medical Sciences Approved 2025-09-17 Ethics Committee of Iran University of Medical Sciences Hemmat Tehran Tehran Iran (Islamic Republic of)