Protocol summary

Summary
We did this pilot study on 10 volunteers that were aware of study processes. This study was approved in the ethics committee of Shahid Beheshti university of medical sciences. We divided the skin of the scalp sagitaly in two parts and randomly inject the platelet rich plasma in one side, and follow the patient every 4 weeks until 4 months and in each sections we took 4 photographs in 4 view, right side, left side, back and top of the scalp. The results were compared using SALT score.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013010612031N1
Registration date: 2013-02-15, 1391/11/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-02-15, 1391/11/27
Registrant information
Name
Faezeh Khademi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
apadana1980@irimc.org
Recruitment status
Recruitment complete
Funding source
Skin research center of shohada-e-tajrish hospital
Expected recruitment start date
2011-09-01, 1390/06/10
Expected recruitment end date
2012-10-26, 1391/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of platelet rich plasma effect on the treatment of chronic alopecia areata
Public title
A pilot study in hair regrowth with local injection of platelet rich plasma in patients with alopecia areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: equal or over 18 years old; clinically diagnosed as alopecia areata totalis; at least 3 years of this illness; no treatment during last 3 months. Exclusion criteria: current and history of malignancy in the body; current benign tumors; hemorrhagic disorders; platelet count below 100000/ml; pregnancy; lactation; and if the patient cannot continue the study.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
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
Skin research center of shohada-e-tajrish hospital
Street address
Tajrish sq
City
Tehran
Postal code
1989934148
Approval date
2010-09-08, 1389/06/17
Ethics committee reference number
89/467

Health conditions studied

1

Description of health condition studied
Alopecia areata totalis
ICD-10 code
L63
ICD-10 code description
Alopecia areata

Primary outcomes

1

Description
local side effect
Timepoint
One week after injection
Method of measurement
Inspection

Secondary outcomes

1

Description
hair regrowth
Timepoint
20 weeks after injection
Method of measurement
SALT score

Intervention groups

1

Description
Intervention: Injection of platelet rich plasma
Category
Treatment - Drugs

2

Description
Control: no treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada-e-Tajrish hospital
Full name of responsible person
Zohreh Tehranchinia
Street address
Tajrish sq
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Skin research center of Shohada-e-Tajrish hospital
Full name of responsible person
Zohreh Tehranchinia
Street address
Tajrish sq
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin research center of Shohada-e-Tajrish hospital
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
skin research center of Shohada-e-Tajrish hospital
Full name of responsible person
Zohreh Tehranchinia
Position
assistant professor
Other areas of specialty/work
Street address
Tajrish sq
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
Zohreh_ tehranchi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Tehranchinia
Position
assistant professor
Other areas of specialty/work
Street address
Tajrish sq
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
Zohreh_ tehranchi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
shahid beheshti university of medical science
Full name of responsible person
Faeze Khademi
Position
resident
Other areas of specialty/work
Street address
Tajrish sq
City
Tehran
Postal code
Phone
00
Fax
Email
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
Loading...