Protocol summary

Summary
To investigate the effects of the Intense Pulsed light source ( IPLS) in Hirsutism remedy. Population study: 37 patients in a private clinic in Birjand, Iran. Inclusion criteria: the women referring to a private surgery for Hirosotism treatment with IPLS. Exclusion criteria: a precedent of the use of any laser method of hair removal on the treating area. For the implementation of this study a square of 1*1 cm on the dense region of the face treating area with a certain distance of the anatomical indexes on that area is chosen and the number of hairs on that surface will be counted. Then patients will be treated by IPLS device. Five sessions will be hold on the basis of every four to six weeks and the patient will be assessed again for the number of hairs after the final session. Meanwhile at every meeting the patient will be assessed for the probable side effects such as erythma.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904024244N1
Registration date: 2010-07-23, 1389/05/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-07-23, 1389/05/01
Registrant information
Name
Reza Ghaderi
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 5402
Email address
ghaderi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Intense Pulsed Light Source in treatment of hirsutism
Public title
Efficacy of Intense Pulsed Light Source in treatment of hirsutism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the women referring to a private clinic for Hirsutism treatment with IPLS. Exclusion criteria: 1- a precedent of the use of any laser method of hair removal on the treating area 2- the existence of infection or scar on the treating area 3-A record of the use of accutane within last year.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 37
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences
City
Birjand
Postal code
Approval date
2010-06-28, 1389/04/07
Ethics committee reference number
556

Health conditions studied

1

Description of health condition studied
Hirsutism
ICD-10 code
L68.0
ICD-10 code description
Hirsutism

Primary outcomes

1

Description
The number of follicles of the hair
Timepoint
One month after the final session
Method of measurement
Hair follicle counting

Secondary outcomes

empty

Intervention groups

1

Description
Facial hair reduction using Intense Pulsed Light Source
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Ghaderi Skin Private Clinic
Full name of responsible person
Street address
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University Of Medical Sciences
Full name of responsible person
Vice Chancellor for Research
Street address
Birjand University of Medical Sciences
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr Reza Ghaderi
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
Valiasr hospital
City
Birjand
Postal code
Phone
+98 56 1444 3001
Fax
Email
ghaderi@bums.ac.ir , rezaghaderi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Reza Ghaderi
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
Valiasr hospital
City
Birjand
Postal code
Phone
+98 56 1444 3001
Fax
Email
ghaderi@bums.ac.ir , rezaghaderi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Sanaz Homayounfar
Position
Medical Student
Other areas of specialty/work
Street address
Birjand University of Medical Sciences
City
Birjand
Postal code
Phone
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
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