Objective: Study the effect of local steroid injection in treatment of melasma. Design: Open label randomized controlled trial. setting: The eligible patients with chronic melasma who will refer to Farshchian Dermatology clinic in 2013. Inclusion criteria: (a) patients with melasma; (b) age between 25 and 40. Exclusion criteria: (a) pregnancy; (b) atrophy in melasma lesion; (c) autoimmune disease; (d) male; (e) telangiectasia in melasma lesion; (f) using oral contraceptive. Intervention: twenty one patients will receive intralesional Triamcinolone injection Spaced 5 millimeters (the concentration of Triamcinolone is 4 milligrams in milliliter). Control: twenty one patients will receive topical formulation (Kligman cream) containing (Tretinoin 0.1 grams, Dexamethasone 0.1 grams, Hydroquinone 5 grams in a cold cream up to 100 grams) every night for two months. Primary outcome: Color changes in lesion. Secondary outcome: Atrophy in lesion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061813699N1
Registration date:2013-09-22, 1392/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
Registrant information
Name
Gholamreza Eshghi
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1252 0183
Email address
gholamrezaeshghi58@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- chancellor for Research and technology, Hamedan University of Medical Science.
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of local steroid injection on reduction of color of melasma lesion in comparison with Kligman pomad in women with facial melasma
Public title
Study the effect of local steroid injection in treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) patients with melasma; (b) age between 25 and 40. Exclusion criteria: (a) pregnancy; (b) atrophy in melasma lesion; (c) autoimmune disease; (d) male; (e) telangiectasia in melasma lesion; (f) using oral contraceptive
Age
From 25 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
On the first visit to the clinic, patients were randomized using a table of random numbers and divided into two intervention and control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Hamedan University of Medical Science
Street address
Hamedan University of Medical Science, Shahid Fahmideh Ave.
City
hamedan
Postal code
6517838695
Approval date
2013-07-04, 1392/04/13
Ethics committee reference number
1043/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Color of Melasma lesion.
Timepoint
Fifteen and 45 days after injection.
Method of measurement
Questionnaire.
Secondary outcomes
1
Description
Atrophy in Melasma lesion.
Timepoint
The first and second months after injections.
Method of measurement
Observation of lesion by researcher.
Intervention groups
1
Description
Intralesional Triamcinolone (Hexal Pharmaceutical company) ampul injection Spaced 5 millimeters (the concentration of Triamcinolone is 4 milligrams in milliliter).
Category
Treatment - Drugs
2
Description
Topical formulation (Cligman cream) containing (Tretinoin 0.1 grams, Dexamethasone 0.1 grams, Hydroquinone 5 grams in a cold cream up to 100 grams) every night one time for two month will be applied on Melasma lesion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchin Hospital
Full name of responsible person
Dr gholamreza Eshghi
Street address
Farshchin Hospital, Mirzadeh Eshghi Ave.
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- chancellor for Research and technology Hamedan University of Medical Science.
Full name of responsible person
Dr Heydar Tavilani
Street address
Hamedan University of Medical Science, Shahid Fahmideh Ave.
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- chancellor for Research and technology Hamedan University of Medical Science.
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
Hamedan University of Medical Science
Full name of responsible person
Dr Gholamreza Eshghi
Position
Specialist in Dermatology
Other areas of specialty/work
Street address
Hamedan University of Medical Science, Shahid Fahmideh Ave.
City
Hamedan
Postal code
Phone
+98 81 1827 4185
Fax
Email
gholamrezaeshghi58@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Dr Gholamreza Eshghi
Position
Specialist in Dermatology
Other areas of specialty/work
Street address
Hamedan University of Medical Science, Shahid Fahmideh Ave.
City
Hamedan
Postal code
Phone
00
Fax
Email
gholamrezaeshghi58@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Dr Gholamreza Eshghi
Position
Specialist in Dermatology
Other areas of specialty/work
Street address
Hamedan University of Medical Science, Shahid Fahmideh Ave.
City
Hamedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)