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Evaluation of carboxy therapy efficacy with NB-UVB phototherapy compared with NB-UVB phototherapy alone in patients with vitiligo

Protocol summary

Study aim
Determination of efficacy of carboxy therapy with NBUVB phototherapy compared with NBUVB phototherapy alone in patients with vitiligo referred to Kerman Afzalipour Hospoital
Design
A randomized controlled clinical trial with 30 vitiligo patients selected from patients referring to Afzalipour Hospital, Ba'athat Clinic and Dermatology Clinic. Sampling is available in this study, double blind
Settings and conduct
The patient with vitiligo is treated at Afzalipour Hospital three times a week according to the protocol. In each patient, one lesion undergoes carboxy therapy and carboxy treatment is performed weekly for 16 weeks.The study is a double-blind study and the patient and evaluator of treatment response have no information about treatment type.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Vitiligo patient with at least 18 years of age, no treatment for 3 months before enrollment, bilatral lesions on both sides Exclusion criteria: photosensetive diseases, segmental vitiligo, autoimmune disease and other treatments, positive Cobner history, previous history of colloid formation, pregnancy, lactation, malignant disease, skin infection in situ, ischemic disease Heart, acute embolism, thrombophlebitis, gangrene, renal failure, hypertension, fever, history of stroke, administration of carbonic anhydrase inhibitors (acetazolamide, diclofenac) and decreased plasma protein levels in chronic liver failure
Intervention groups
The patient is treated with phototherapy three times a week according to the protocol. In each patient, one lesion undergoes carboxy therapy and carboxy treatment is performed weekly for 16 weeks. Control group: Phototherapy is performed three times a week in patients with sympathetic vitiligo lesions.
Main outcome variables
Rate of recovery Complication rate Pigmentation type

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190517043610N1
Registration date: 2020-02-15, 1398/11/26
Registration timing: registered_while_recruiting

Last update: 2020-02-15, 1398/11/26
Update count: 0
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
fatemeh yazdanpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8000
Email address
f.yazdanpanah86@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of carboxy therapy efficacy with NB-UVB phototherapy compared with NB-UVB phototherapy alone in patients with vitiligo
Public title
The Effect of Carboxy Therapy on Vitiligo Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Vitiligo disease with sympathetic involvement on both sides of the body
Exclusion criteria:
Photosynthetic Diseases Segmental vitiligo Autoimmune Disease Use of other vitiligo treatments such as topical corticosteroids and topical calcineurin. Patient with positive Kobner history and previous history of colloid formation pregnancy and lactation malignancy Infection at the injection site Severe ischemic heart disease, acute embolism, thrombophlebitis, gangrene, history of stroke renal failure hypertension Use of carbonic anhydrase inhibitors (acetazolamide, diclofenac) Decreased plasma protein levels in chronic hepatic failure
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Evaluation of patients by an evaluating physician who has no treatment information is performed at the end of treatment and patients are unaware of the type of treatment.
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
Emam khomeini blvd,kerman town
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2019-07-07, 1398/04/16
Ethics committee reference number
IR.KMU.AH.REC.1398.033

Health conditions studied

1

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

Primary outcomes

1

Description
Skin pigmentation of lesions
Timepoint
Before treatment and one month, two months, three months and four months after treatment
Method of measurement
Questionnaire designed by the researcher

Secondary outcomes

empty

Intervention groups

1

Description
The patient will be treated with phototherapy three times a week according to the protocol. In each patient, one lesion undergoes carboxy therapy and carboxy therapy is performed weekly for 16 weeks. The rate of gas infusion is 50 cc / min and the total amount of gas injected in each lesion is 3 cc and the median time of each session is 5 to 8 minutes.
Category
Treatment - Devices

2

Description
Control group: Patient with bilatral vitiligo lesions treated with protocol three times a week according to protocol
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital, Ba'ath Clinic
Full name of responsible person
Saiede Farajzade
Street address
Emam Khomeini Blvd,Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
Safaderm@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
The beginning of the axis of the seven gardens of Alavi campus of Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
abapardakhty@kmu.ac.ir
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
Saiede Farajzade
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Emam Khomeini blvd,Afzalipor Hospital
City
Kerman
Province
Kerman
Postal code
7616913991
Phone
+98 34 3132 8000
Email
Safaderm@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saiede Farajzade
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Emam Khomeini Blvd,Afzalipor Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
Safaderm@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fateme Yazdanpanah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Emam Khomeini Blvd,Afzalipor Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
f.yazdanpanah86@yahoo.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
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