This study was designed with an exploratory purpose regarding the optimal treatment of melasma with topical and oral melatonin as an adjuvant treatment. The findings of this study could lead to improved management strategies for the treatment of melasma and potentially reduce the need for more invasive treatments with more side effects.
Design
A clinical trial with two groups of case and control, a randomized blind strain, phase 3 on 44 patients
Settings and conduct
Sampling will be done in a convenient way and from all eligible people to enter the study who refer to dermatology clinics affiliated to Isfahan University of Medical Sciences during the study period to complete the sample size
Participants/Inclusion and exclusion criteria
All people over 18 years of age who visited dermatology clinics affiliated to Isfahan University of Medical Sciences between the fall of 1402 and the end of winter 1402 and have a confirmed clinical diagnosis of melasma and have the following entry criteria: 1. Obtaining a score of at least 10 for melasma intensity and area index (Masi score). 2. Not using other melasma topical treatments at least 2 weeks before participating in the research project 3. Not using systemic steroids to treat melasma at least 1 month before participating in the research project 4. Not using other treatment methods such as laser to treat melasma for at least 3 months before participating in the research project 5. Consent and informed consent of the person to enter this research project
Intervention groups
1. Case group: receiving 2% hydroquinone ointment and 1% melatonin and 10 mg melatonin tablets made by Razak Shabi factory for 4 weeks.
2. Control group: receiving 2% hydroquinone ointment twice a day for 4 weeks
Main outcome variables
Decrease in the severity index score and area index score of melasma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090808002306N10
Registration date:2024-07-11, 1403/04/21
Registration timing:prospective
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Ali Mohammad Sabzghabaee
Name of organization / entity
Isfahan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7070
Email address
sabzghaba@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effectiveness of melatonin as an add-on treatment to the common treatment of melasma
Public title
Melatonin in melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining the intensity and melasma area index score (massi score) 10
Not using other topical treatments at least two weeks before participating in the research project
No use of systemic steroids for the treatment of melasma for at least one month before participating in the research project
Not using other treatment methods such as laser to treat melasma for at least 3 months before participating in the research project
Consent and informed consent of the person to enter this research project
Exclusion criteria:
Patients non-compliance to the study protocol
Utilization of other anti melasma treatments
Patients' personal will to the exclusion from the study
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with an even national ID number will considered as cases and Patients with an odd national ID number will considered as controls
Blinding (investigator's opinion)
Single blinded
Blinding description
Packaging of the pharmaceutical dosage forms in both groups will be identically the same in case of color and apparent characteristics and the participants of the control group do not know that the received substance does not contain melatonin and only contains hydroquinone (the main treatment of the disease)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-12-12, 1402/09/21
Ethics committee reference number
IR.MUI.PHANUT.REC.1402.048
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Melasma score in Masi index
Timepoint
Measuring melasma recovery before treatment and 4 weeks after treatment
Method of measurement
Masi measurement index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the standard treatment, which is a topical cream containing 2% hydroquinone, melatonin cream is given at night along with a 10 mg melatonin tablet manufactured by Razak Factory for a period of 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: The standard treatment is 2% hydroquinone cream twice a day for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Al-Zahra Hospital, Isfahan
Full name of responsible person
Dr. Mehrdad Noroozi
Street address
Sofeh St. - Al-Zahra Medical Education Center
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shahin Shirani
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, central headquarters
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 9500
Email
Shakibakianpour77@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shakiba Kianpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shafaq Boulevard, alley number 16, 4-storey house, unit 3
City
Isfahan
Province
Isfehan
Postal code
8178634184
Phone
+98 922 094 4035
Email
Shakibakianpour77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Alimohammad Sabzghabaee
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, central headquarters
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7070
Email
sabzghaba@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shakiba Kianpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shafaq Boulevard, alley number 16, 4-storey house, unit 3
City
Isfahan
Province
Isfehan
Postal code
8178634184
Phone
+98 922 094 4035
Email
Shakibakianpour77@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available