1. Home
  2. Approved trials
  3. » فارسی

Investigating the Effectiveness of Combined Treatment of Carboxytherapy with Platelet-Rich Plasma (PRP) Compared To PRP, in Patients with Vitiligo Treated with Phototherapy

Protocol summary

Study aim
Investigating the Effectiveness of Combined Treatment of Carboxytherapy with Platelet-Rich Plasma (PRP) Compared To PRP, in Patients with Vitiligo Treated with Phototherapy
Design
This Is an Interventional Study That Includes 30 Patients with Vitiligo Aged At Least 18 Years Who Have Not Received any Treatment for Vitiligo In the last 3 Months Prior To Entering the Study and Whose Lesions are Similar on both Sides. Referees to Afzalipour Hospital Are Selected for Light Therapy and Are Included in The Study. The Sampling Method in This Study Is Available.
Settings and conduct
This Is an Interventional Study in Which Patients with Vitiligo Who Have Not Received Any Treatment for Vitiligo for 3 Months Before Entering the Study and Whose Lesions are Similar on Both Sides, Are Among the Patients Referred to Afzalipour Hospital. They are Selected for Light Therapy and Enter the Study. The Sampling Method in this Study is Available.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: A Patient with Vitiligo Exit Criteria: Exit Criteria: Photosensitive Diseases, Segmental Vitiligo, Patients With A Positive Köbner History, Previous History of Keloid Formation, Pregnancy, Breastfeeding, History of Malignant Diseases, Presence of Skin Infection at the Site, Cardiovascular Disease, Acute Embolism, Thrombophlebitis, Kidney Failure, Use Of Inhibitors Carbonic Anhydrase (Acetazolamide, Diclofenac), Systemic Disease, Bleeding Disorders or Use of Anticoagulant Drugs And Vasovagal Syncope
Intervention groups
In each Patient, two Similar Lesions are Selected for Treatment, which are Randomly on The Right or Left Side Treated with PRP or PRP with Carboxytherapy. For all Patients, Light therapy is Performed three times a Week according to the Protocol.
Main outcome variables
Status of Vitiligo Lesions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230601058354N1
Registration date: 2023-07-04, 1402/04/13
Registration timing: prospective

Last update: 2023-07-04, 1402/04/13
Update count: 0
Registration date
2023-07-04, 1402/04/13
Registrant information
Name
Shima Estabragh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 9100 1480
Email address
shimaestabragh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-20, 1402/04/29
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effectiveness of Combined Treatment of Carboxytherapy with Platelet-Rich Plasma (PRP) Compared To PRP, in Patients with Vitiligo Treated with Phototherapy
Public title
Investigating the Effectiveness of Combined Treatment of Carboxytherapy with Platelet-Rich Plasma (PRP) Compared To PRP, in Patients with Vitiligo Treated with Phototherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A Patient with Vitiligo
Exclusion criteria:
Photosensitive Diseases Segmental Vitiligo Patient with positive Kübner's History Previous History of Keloid Formation Pregnancy Breastfeeding History of Malignant Diseases Presence of Skin Infection at the Site Cardiovascular Disease Acute Embolism Thrombophlebitis Kidney Failure Use of Inhibitor Carbonic Anhydrase (Acetazolamide, Diclofenac), Systemic Disease Bleeding disorders or use of Anticoagulant Drugs Vasovagal Syncope
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
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
Ethics committee of Kerman University of Medical Sciences
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2023-04-08, 1402/01/19
Ethics committee reference number
IR.KMU.AH.REC.1402.004

Health conditions studied

1

Description of health condition studied
Vitiligo Disease
ICD-10 code
L80
ICD-10 code description
Vitiligo

Primary outcomes

1

Description
Status of Vitiligo Lesions
Timepoint
For all Patients, Light therapy was Performed Three times a week according to the Protocol. It Was Evaluated monthly during the Treatment and 4 Months after the end of the Treatment.
Method of measurement
The Diagnosis of the Disease was Made Clinically by a Dermatologist and then confirmed with the help of Wood's Lamp Test.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In each Patient, two Similar Lesions are Selected for Treatment, which are Randomly Treated with PRP on the Right or Left Side. For all Patients, Light Therapy is Performed Three Times a Week According to the Protocol.
Category
Treatment - Devices

2

Description
Intervention group 2: In each Patient, Two Similar Lesions are Selected for Treatment, which are Randomly Placed on the Right or Left Side Under PRP Treatment with Carboxytherapy. For all Patients, Light Therapy is Performed Three Times a Week According to the Protocol.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Shima Estabragh
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
Shimaestabragh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shima Estabragh
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
Shimaestabragh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shima Estabragh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
Shimaestabragh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shima Estabragh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
Shimaestabragh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shima Estabragh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
0098343132800
Email
Shimaestabragh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...