In this double-blind randomized clinical trial, Cysteamine hydrochloride cream (new skin depigmenting agent) is investigated in the treatment of melasma, and Consecutive Sampling is done. Inclusion criteria are: men and women aged 18 to 50 years; skin types III, IV, V, epidermal melasma approved by wood light; melasma for more than 6 months; patient who are able to read, understand and sign the consent form for periodic visits. The patients are divided in two groups of 25 with block randomization. Cysteamine and placebo will be applied for four months, once daily. Dermal or mixed type melasma, patients with any chronic infection with treating medication, history of using OCP and corticosteroids at the time of or 3 months before entering the study, hormonal disorders and pregnant women and lactating mothers are excluded. Expected outcome are clinical improvement; calculation MASI scores before and after 2 and 4 months of application of topical creams (Cysteamine or placebo) and also melasma pigmentation measured by Mexameter before and after 2 and 4 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212059800N2
Registration date:2013-03-13, 1391/12/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-03-13, 1391/12/23
Registrant information
Name
Parvin Mansouri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6659 5911
Email address
mansorip@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin stem cell research center, Tehran University of Medical sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2014-04-04, 1393/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Topical Cysteamine cream in the treatment of epidermal melasma: A double blind randomized placebo controlled trial
Public title
Effectiveness of Topical Cysteamine cream in the treatment of epidermal melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: men and women aged 18 to 50 years; skin types III, IV, V, epidermal melasma diagnosis confirmed by a wood light; Melasma duration for more than 6 months.
Exclusion criteria: dermal and mixed type of melasma; using OCP during the study and 3 months before entering the study; treatment with corticosteroids; hormonal disorders; pregnant and lactating mothers.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences and Health Services
Street address
Ghodss St., Keshavarz Blvd
City
Tehran
Postal code
1417653761
Approval date
2012-11-17, 1391/08/27
Ethics committee reference number
91-03-150-19422-67930
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Melasma
Primary outcomes
1
Description
mexameter changes
Timepoint
Before intervention, 2 & 4 months after intervention
Method of measurement
Erythema & Melanin measured by Mexameter
Secondary outcomes
1
Description
Patient clinical improvement
Timepoint
Before intervention, 2 & 4 months after intervention
Method of measurement
Physician's global score (inspection & comparing the photos)
2
Description
MASI Score
Timepoint
Before intervention, 2 & 4 months after intervention
Method of measurement
Physician's global score (inspection & comparing the photos)
3
Description
MASI score
Timepoint
Before intervention, 2 & 4 months after intervention
Method of measurement
Erythema and pigment measured by Dermacatch
Intervention groups
1
Description
Intervention 2: Vehicle cream in control group for 4 months, once in a day
Category
Placebo
2
Description
Intervention 1: Cysteamine cream in intervention group for 4 months, once in a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin clinic of Imam Khomeini hospital
Full name of responsible person
Dr. Parvin Mansouri
Street address
Imam Khomeini hospital
City
Tehran
2
Recruitment center
Name of recruitment center
Skin Clinic of Dr Mansouri
Full name of responsible person
Dr. Parvin Mansouri
Street address
No.458,Mahan Building,Yousef Abad
City
Tehran
3
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center
Full name of responsible person
Dr. Parvin Mansouri
Street address
No.4, Maryam Dd., Kamranyeh
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Parvin Mansouri
Street address
Skin Ward,Imam Khomeini Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Susan Farshi
Position
MD, MPH
Other areas of specialty/work
Street address
Skin Ward,Imam khomeini Hospital ,Kheshavarz BLV.
City
Tehran
Postal code
1417653761
Phone
+98 21 6659 5911
Fax
Email
farshi_s@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin & ٌُُُُُُStem cell research centere, Dermatology department, Imam khomeini hospital, Tehran uni
Full name of responsible person
Dr. Parvin Mansouri
Position
Professor of dermatology
Other areas of specialty/work
Street address
Skin ward, Imam Khomeini hospital
City
Tehran
Postal code
1417653761
Phone
+98 21 6659 5911
Fax
Email
mansorip@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Univeristy of Medical Science
Full name of responsible person
Dr. Parvin Mansouri
Position
Dermatology,Professor
Other areas of specialty/work
Street address
Skin Ward,Imam khomeini Hospital ,Kheshavarz BLV.
City
Tehran
Postal code
1417653761
Phone
+98 21 6659 5911
Fax
Email
mansorip@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)