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Evaluation of the effect of Mamogol cream in comparison with Hydrocortisone 1% on mild to moderate hand irritant contact dermatitis, clinical trial

Protocol summary

Study aim
Primary Objective: To determine the efficacy of Mamogel cream compared with 1% hydrocortisone ointment in reducing symptoms of mild to moderate irritant contact dermatitis of the hands.
Design
A phase III randomized, double‑blind, parallel‑group clinical trial will be conducted on 90 patients, including an intervention group and a control group. Randomization will be performed using the Random Allocation Software.
Settings and conduct
Patients with mild to moderate hand eczema at Hazrat Rasool Hospital and Behesht Health Center apply their medication for two weeks. The patients are blinded and receive the medication through sealed envelopes
Participants/Inclusion and exclusion criteria
Inclusion Criteria: - Individuals aged 12–65 years, 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 medical treatment for hand dermatitis for at least one week prior to enrollment, and have not used topical corticosteroids during the past week. Exclusion Criteria: - Patients reporting a history of allergy to Althaea officinalis (marshmallow plant). - Patients currently receiving other corticosteroid medications, antibiotics, or skin‑drying agents such as isotretinoin (Roaccutane).
Intervention groups
The intervention group consists of patients with mild to moderate hand eczema who receive Mamogel cream. The comparison group includes patients with mild to moderate hand eczema who receive 1% hydrocortisone ointment.
Main outcome variables
HECSI Score, Quality of life, Recurrence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250923067342N1
Registration date: 2025-11-18, 1404/08/27
Registration timing: registered_while_recruiting

Last update: 2025-11-18, 1404/08/27
Update count: 0
Registration date
2025-11-18, 1404/08/27
Registrant information
Name
Zahra sadat Akhlaghi Kalahrodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 9667
Email address
dr.zs.akhlaghi@iran.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-17, 1404/07/25
Expected recruitment end date
2026-10-17, 1405/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Mamogol cream in comparison with Hydrocortisone 1% on mild to moderate hand irritant contact dermatitis, clinical trial
Public title
Evaluation of the effect of Mamogol cream on mild to moderate hand irritant contact dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 12 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
The creams will be dispensed in identical, unlabeled containers.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2025-09-17, 1404/06/26
Ethics committee reference number
IR.iums.rec.1404.636

Health conditions studied

1

Description of health condition studied
mild to moderate Irritant contact dermatitis of hand
ICD-10 code
L24
ICD-10 code description
Irritant contact dermatitis

Primary outcomes

1

Description
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.

Secondary outcomes

1

Description
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

2

Description
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

3

Description
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

Intervention groups

1

Description
Intervention group: Patients apply Mamogel cream (produced by Goldaroo Pharmaceutical Company) topically to the affected area twice daily for two consecutive weeks
Category
Treatment - Drugs

2

Description
Control group: Patients apply 1% hydrocortisone ointment to the affected area twice daily for two weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Zahra sadat Akhlaghi
Street address
Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
rasoolhospital@iums.ac.ir

2

Recruitment center
Name of recruitment center
Salamatkade Behesht
Full name of responsible person
Zahra sadat Akhlaghi
Street address
Behesht
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 6672 5925
Email
info.irantms@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr jamshidi
Street address
behesht
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
info.irantms@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
zahra sadat akhlaghi
Position
PHD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Behesht
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9667
Email
dr.zs.akhlaghi@iran.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra sadat akhlaghi
Position
PHD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Behesht
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9667
Email
dr.zs.akhlaghi@iran.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra sadat Akhlaghi
Position
PHD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Behesht ave.
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9667
Email
dr.zs.akhlaghi@iran.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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