A randomized double blind placebo controlled clinical trial study is designed to evaluate the effect of topical T3 hormone on Alopecia Areata. This study will be performed by collaboration of skin Research center of shahid Beheshti Medical University and Endocrine and Metabolism research Institute of Tehran Medical University. This is a phase II clinical trial. 10 patients with at least two patches of alopecia areata on 2 different sides of body will be recruited. Complete history will be taken and patients with clinical and para clinical signs and symptoms of thyroid disease will be excluded from study. The size of the alopecia patch will be measured before therapy. T3 cream is composed of 3.8 microgram of T3 in each 30 microgram of novasome A. Novasome A will be used as placebo. The patient will apply T3 hormone on one side and placebo on the other side for 12 weeks. The size of the patch, the hair count, hair type (velus or terminal) and hair color (white or black) will be determined every 4 weeks. Thyroid function test, Liver function test and CBC will be performed before the start and at the end of therapy. At the beginning of the study and every 4 weeks a photograph will be taken from the lesions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902141414N14
Registration date:2010-05-28, 1389/03/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-28, 1389/03/07
Registrant information
Name
Bagher Larijani
Name of organization / entity
Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0037
Email address
emrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrinology and Metabolism Research Institute of Tehran university of medical sciences
Expected recruitment start date
2009-04-01, 1388/01/12
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of Topical T3 Hormone and placebo in treatment of patients with Alopecia Areata
Public title
Topical T3 Hormone effect in alopecia areata
Purpose
Treatment
Inclusion/Exclusion criteria
exclusion criteria: 1. clinical or paraclinical evidence of thyroid dysfunction (hypo or hyperthyroidism)
2. paraclinical data confirming abnormality of CBC,LFT
3. patients with Alopecia Totalis or universalis.
inclusion: Patients with at least 2 patches of alopecia on 2 different side of body
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
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
Endocrinology and Metabolism research institute of Tehran Medical University
Street address
Shariati Hospital.North Karegar Ave.
City
Tehran
Postal code
Approval date
2009-03-01, 1387/12/11
Ethics committee reference number
E-0087
Health conditions studied
1
Description of health condition studied
Alopecia Areata
ICD-10 code
L63
ICD-10 code description
Alopecia areata
Primary outcomes
1
Description
Hair regrowth
Timepoint
At the begining, every four weeks and at the end
Method of measurement
Observation and photography
Secondary outcomes
1
Description
Hair color
Timepoint
at the begining, every4 weeks and at the end
Method of measurement
observation
Intervention groups
1
Description
Topical T3 cream, 3.8 microgram of T3 in each 30 microgram of novasome A, two times daily for 12 weeks. The patient will apply T3 hormone on one side and placebo on the other side.
Category
Treatment - Drugs
2
Description
Novasome A will be used as placebo and applied in the same way as the intervention group on the other side
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-e-Tajrish Hospital.
Full name of responsible person
Marjan Saeedi
Street address
Shahrdari Ave,Shohada-e-Tajrish Hospital.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Institute of Tehran University of Medical Sciences
Full name of responsible person
Ramin Heshmat
Street address
Shariati Hospital, North Karegar Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Institute of 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrinology and Metabolism Research Institute of Tehran university of medical sciences
Full name of responsible person
Bagher Larijani
Position
MD
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar Ave
City
Tehran
Postal code
Phone
+98 21 8822 0037
Fax
Email
emrc@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
skin Reserch center of shahid Beheshti Medical university
Full name of responsible person
Marjan Saeedi
Position
MD
Other areas of specialty/work
Street address
Shohada-e-Tajrish Hospital, Shahrdari Ave
City
Tehran
Postal code
Phone
+98 912 216 6322
Fax
Email
marjan406@yahoo.com; msaeedi1360@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)