Protocol summary

Summary
The study is designed to compare the additive efficacy of fractional CO2 laser with topical tranexamic acid gel in the treatment of melasma. The study is a randomized, single-blin, unicenter, clinical trial. Inclusion criteria include patients with epidermal and mixed melasma and diseased for at least 6 months. Exclusion criteria include dermal type melasma, oral contraceptive pill consumption since 3 months before enrolement in the study, topical or oral corticosteroid consumption, other pigmentation disorders,history of endocrinopaty disorders, pregnancy, lactation, topical depigmenting medication application in the recent 1 month, oral retinoids or oral and injectable tranexamic acid consumption in the recent 6 months. The patients are selected by convenient sampling from tinea versicolor patients referred to dermatology clinic of Faghihi hospital in Shiraz and 25 patients are enrolled in the study. The patients receive two treatments in both sides of their face by block randomization. In the intervention side which is determined by block randomization, once monthly fractional CO2 laser is done besides twice daily topical application of tranexamic acid gel and in the control side, only topical tranexamic acid gel is applied twice daily. Primary outcome measure is melanin content measured by Dermacatch instrument and secondary outcome measures are modified Melasma Area and Severity Index (mMASI), investigator global scale and patient global scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017080716557N3
Registration date: 2017-08-13, 1396/05/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Mozhdeh Sepaskhah
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 712125239
Email address
sepaskhah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research council of Shiraz University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of topical tranexamic acid 5% gel with and without fractional CO laser therapy in treatment of melasma
Public title
Effect of fractional CO2 laser and Tranexamic acid gel in the treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with epidermal and mixed melasma; diseased for at least 6 months Exclusion criteria: Dermal type melasma; Oral contraceptive pill consumption since 3 months before enrolement in the study; Topical or oral corticosteroid consumption; Other pigmentation disorders; History of endocrinopaty disorders; Pregnancy; Lactation; Topical depigmenting medication application in the recent 1 month; Oral retinoids or oral and injectable tranexamic acid consumption in the recent 6 months
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz. Iran
City
Shiraz
Postal code
Approval date
2017-06-14, 1396/03/24
Ethics committee reference number
IR.SUMS.MED.REC.1396.48

Health conditions studied

1

Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma

Primary outcomes

1

Description
Melanin content
Timepoint
months 0, 1, 2, 3
Method of measurement
A number measured by Dermacatch

Secondary outcomes

1

Description
modified Melasma Area and Severity Index (mMASI)
Timepoint
months 0, 1, 2, 3
Method of measurement
Scoring of color and extent of lesions and calculation based on the formula

2

Description
Investigator global scale
Timepoint
months 0, 1, 2, 3
Method of measurement
Investigator's assessment of global severity of the lesion

3

Description
Patient global scale
Timepoint
months 0, 1, 2, 3
Method of measurement
Patient's assessment of global severity of the lesion

Intervention groups

1

Description
Intervention side: Once monthly fractional CO2 laser (DSE, South Korea), 169 dots per pulse, energy 12mJ, 1-2 pass for 3 sessions is done besides twice daily topical application of tranexamic acid 5% gel for 3 months
Category
Treatment - Surgery

2

Description
Control side: Only topical tranexamic acid 5% gel is applied twice daily for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology clinic, Shahid Faghihi hospital
Full name of responsible person
Leila sadat Khamesi
Street address
Dermatology clinic, Faghihi hospital, Zand St., Shiraz, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Research Council, Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
93-01-01-8716
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila sadat Khamesi
Position
Resident
Other areas of specialty/work
Street address
Dermatology clinic, Faghihi hospital, Zand St., Shiraz, Iran
City
Shiraz
Postal code
7134844119
Phone
+98 71 3231 9049
Fax
+98 71 3231 9049
Email
l.khamesi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
City
Shiraz
Postal code
7134844119
Phone
+98 71 3212 5239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3212 5239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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