Determination and comparison of the effect of cysteamine 5% cream and hydroquinone 4% cream in treatment of epidermal melasma
Design
Phase 3, parallel group, clinical trial, with consecutive sampling, including 98 patients, single blinded, computerized randomized with permuted blocks
Settings and conduct
The study is conducted in the dermatology clinic of Shiraz University of Medical Sciences. Group 1 applied cyseamine 5% cream and group 2 applied hydroquinone 4% cream nightly on the face. The patients are assessed at the beginning of treatment, 2nd month and 4th month by SkinColorCatch and photography by Visioface. The investigator is blind to the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 18 to 50 years; epidermal melasma
Exclusion criteria: dermal melasma; consumption of melasma causing medications; consumption of melasma treatments; pregnancy; lactation
Intervention groups
Group 1: Cysteamine 5% cream
Group 2: Hydroquinone 4% cream
Main outcome variables
Measuring melanin index; Determination of modified melasma area severity index score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140212016557N4
Registration date:2018-10-22, 1397/07/30
Registration timing:registered_while_recruiting
Last update:2018-10-22, 1397/07/30
Update count:0
Registration date
2018-10-22, 1397/07/30
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
Expected recruitment start date
2018-03-16, 1396/12/25
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic efficacy of cysteamine 5% cream with Hydroquinon 4% cream in epidermal melasma patients
Public title
Comparison of the effect of cysteamine cream and hydroquinone cream in the treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Epidermal melasma confirmed by Wood's lamp
Duration of melasma more than 6 months
Age 18 to 50 years
Exclusion criteria:
Dermal melasma
OCP consumption during or in the past 3 months before the study
Consumption of oral or topical corticosteroids on the site of melasma during the study
Intolerance to hydroquinone or cysteamine as severe irritation
Other pigmentary disorders
Pregnancy
Lactation
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomized using permuted block randomization (size of each block: 4), in individual units, using random allocation software.
The medications are in the similar tubes labeled by numbers of the patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
Despite of close similarity of medications tubes, the participants cannot be blind because of the different instructions for use. Principle investigator, the drug presentation staff, and care provider physician are also aware of the type pf drugs. But, data collectors and outcome assessors are not aware of the medication of each patient.
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
Imam Husain square, Zand St.
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2018-07-16, 1397/04/25
Ethics committee reference number
IR.SUMS.MED.REC.1397.181
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 index
Timepoint
before intervention and 2 and 4 months after intervention
Method of measurement
SkinColorCatch instrument
Secondary outcomes
1
Description
modified Melasma Area and Severity Scale score
Timepoint
before intervention and 2 and 4 months after intervention
Method of measurement
modified Melasma Area and Severity Scale score formula
2
Description
Lee's investigator global assessment score
Timepoint
2 and 4 months after intervention
Method of measurement
5-point Likert scale for Lee's investigator global assessment score
3
Description
Lee's patient global assessment score
Timepoint
2 and 4 months after intervention
Method of measurement
5-point Likert scale for Lee's patient global assessment score
Intervention groups
1
Description
Intervention group: Cysteamine 5% cream (Scentispharma, Switzerland) is applied once every night for 15 minutes for 4 months on the face skin.
Category
Treatment - Drugs
2
Description
Control group: آydroquinone 4% cream which is made by dissolution of 2 grams powder of hydroquinone (Merck, Germany) and 1.5 grams ascorbic acid powder (Merck, Germany) in 50 grams of vanishing cream (Minoo, Iran) is applied once every night overnight for 4 months on the face skin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic, Shahid Faghihi hospital
Full name of responsible person
Mozhdeh Sepaskhah
Street address
Dermatology clinic, Faghihi hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5239
Email
sepaskhah@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Yunos Ghasemi
Street address
Research Council, Shiraz University of Medical Sciences, Zand St
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Research grant of the Research Council of Shiraz University of Medical Sciences
Grant code / Reference number
1396-01-01-16288
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Dermatology clinic, Faghihi hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5239
Email
sepaskhah@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Dermatology clinic, Faghihi hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Dermatology clinic, Faghihi hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134844119
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)
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