Determination of the effectiveness of Cysteamine 5% cream compared with Tranexamic acid mesotherapy on the severity of epidermal Melasma.
Design
The clinical trial with two groups (intervention and control), pragmatic, one-blind, randomized
Settings and conduct
This study will be conducted to evaluate the effect of Cysteamine 5% cream in comparison with Tranexamic acid mesotherapy on the severity of epidermal melasma in a specialized clinic of Vasesi Hospital in Sabzevar. Patients will be randomly assigned to intervention group 1 (Cysteamine 5% cream) and Intervention 2 (Tranexamic acid Mesotherapy). The response to treatment is evaluated MASI (Melasma Area Severity Index) index and Derma catch® score for the intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 and 50 years, Patients who have been at least 6 months old since their illness, Patients who have not received any medication for at least 2 months Exclusion Criteria: History of Endocrine diseases, pregnancy and breastfeeding, Any Corticosteroids treatment 3 months before study, Use of oral contraceptive pills before study, Other skin diseases.
Intervention groups
First Intervention group: Patients in this group use Cysteamine 5% cream at night for 2 months. Second Intervention group: In this group, 4 mg/cc of Tranexamic acid will be injected intradermally every 4 weeks, and the skin of the patient was rinsed with normal saline and then anesthetized with local anesthetic ointment (ELMA) for 40 to 60 minutes, and then, the Tranexamic acid is injected at intervals of 10 mm from the involved area to three areas for full coverage of the lesion using an insulin syringe (Nidel 28J) under sterile conditions. In addition, the injectable dose will not exceed 8 mg/cc during three injections per injection.
Main outcome variables
Determine the severity of the area involved in Melasma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181006041252N2
Registration date:2018-11-29, 1397/09/08
Registration timing:registered_while_recruiting
Last update:2018-11-29, 1397/09/08
Update count:0
Registration date
2018-11-29, 1397/09/08
Registrant information
Name
Mohammad Sahebkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8337
Email address
sahebkarm@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-29, 1397/08/07
Expected recruitment end date
2018-12-28, 1397/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Cysteamine 5% cream with Tranexamic acid Mesotherapy on the severity of epidermal Melasma.
Public title
Comparison of the effect of Cysteamine 5% cream with Tranexamic acid Mesotherapy on the severity of epidermal Melasma.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 50 years
Patients who have been at least 6 months old since their illness
Patients who have not received any medication for at least 2 months
Exclusion criteria:
History of Endocrine diseases, pregnancy and breast feeding
Any Corticosteroids treatment 3 months before study
Use of oral contraceptive pills before study
Other skin diseases
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization based on permutation. Accordingly, 27 blocks were allocated to patients, in each block 2 from A treatment group and 2 from the B treatment group were placed. Eventually, after completion of the blocks, group A was treated with Cysteamine 5% cream and Group B treated with Tranexamic Acid Mesotherapy.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each person in the study will be assigned code A and B, that the researcher will only be known of the type of groups. The outcome evaluator is unaware of the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2018-10-29, 1397/08/07
Ethics committee reference number
IR.MEDSAB.REC.1397.053
Health conditions studied
1
Description of health condition studied
Epidermal Melasma
ICD-10 code
L85
ICD-10 code description
Other epidermal thickening
Primary outcomes
1
Description
Determine the severity of the area involved in Melasma
Timepoint
Week 4 and 8 after starting the intervention for Tranexamic acid and months 2 and 4 after the intervention for the Cysteamine group
Method of measurement
Based on Derma catch® score and MASI index (Melasma Area Severity Index)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group use cysteamine 5% cream at night for 2 months, and also during a day they use a sunscreen with SPF 25% with zinc oxide 7.5% daily.
Category
Treatment - Drugs
2
Description
Intervention group: In this group, 4 mg/cc of tranexamic acid will be injected intradermally every 4 weeks, and The skin of the patient was rinsed with normal saline and then anesthetized with local anesthetic ointment (ELMA) for 40 to 60 minutes, and then, the tranexamic acid is injected at intervals of 10 mm from the involved area to three areas for full coverage of the lesion using an insulin syringe (Nidel 28J) under sterile conditions. In addition, the injectable dose will not exceed 8 mg/cc during three injections per injection. During a day they will use a sunscreen with SPF 25% with zinc oxide 7.5% daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei hospital
Full name of responsible person
Yegane AbdollahNejad Nasiri
Street address
Vasei Hospital, Asadabady Ave., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1014
Email
Yegane6750@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Maryam Karrabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
Marikori90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Maryam Karrabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
Marikori90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Yegane Abdollahnejad Nasiri
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Email
Yegane6750@yahoo.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
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available