Protocol summary

Study aim
Comparative efficacy of intralesional Cryotherapy vs intralesional Corticosteroid . 5 Fluorouracil in the treatment of hypertrophic scars and keloids
Design
This interventional research would be conducted on patients with hypertrophic and colloid, admitted to the Skin Clinic of Sina Hospital from August 2016 to May 2017, after being approved by the Research Committee and the Ethics Committee. This research is double-blinded experimental, interventional (clinical trial) study, in which researcher and patient are not aware of the treatment method, and patients would be distinguished with manual coding. A checklist would be prepared by the research executor and it would be completed individually by each patient. Then, the patients would be randomly assigned to three distinct groups based on random numbers table, and each stage would be evaluated by the project assistant. The number of subjects in each group would be 21. The first group would be treated with intralesional injection of cryotherapy. The second and third groups would be treated with intralesional injection of steroids and 5-fluoroacrylate, respectively. Before starting treatment, the type of scar (hypertrophic or colloid) is determined and its size is measured and it would be recorded along with the appearance characteristics, such as color, erythema, telangiectasia, and symptoms associated with the lesion. Cryotherapy would be injected intralesionally using a special probe and freezing within the tissue. The steroid used in this research is triamcinolone 40 mg / ml and the amount of its intralesional injection would be 0.2 ml / cm². The amount of intralesional injection for 5-fluorouracil 250 ml / 5 ml would be 0.2 ml/cm². Treatment would be repeated every 4 weeks and up to 6 sessions, depending on the scar tissue. Before and after treatment, image of lesions is prepared. Scare severity is measured using the vernier scale. In each treatment session, the size and appearance of scars are examined and recorded in the checklist.
Settings and conduct
This interventional research would be conducted on patients with hypertrophic and colloid, admitted to the Skin Clinic of Sina Hospital from August 2016 to May 2017, after being approved by the Research Committee and the Ethics Committee.
Participants/Inclusion and exclusion criteria
Patients with Hypertrophic Osteoarthritis and Osteoarthritis will be studied andThe exclusion criteria of research include pregnant and breastfeeding women, age less than 12 years, history of allergy to the drugs used in the research, patients with uncontrolled blood pressure, liver and kidney disease, immune system deficiency and reduction in blood cell levels.
Intervention groups
The first group would be treated with intralesional injection of cryotherapy. The second and third groups would be treated with intralesional injection of steroids and 5-fluoroacrylate, respectively
Main outcome variables
Scar Volume

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100314003566N9
Registration date: 2018-03-04, 1396/12/13
Registration timing: registered_while_recruiting

Last update: 2018-03-04, 1396/12/13
Update count: 0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Hamide Azimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
azimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-30, 1396/11/10
Expected recruitment end date
2019-05-31, 1398/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of intralesional Cryotherapy vs intralesional Corticosteroid 5 Fluorouracil in the treatment of hypertrophic scars and keloids
Public title
Comparative efficacy of intralesional Cryotherapy vs intralesional Corticosteroi 5 Fluorouracil in the treatment of hypertrophic scars and keloids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients withof hypertrophic scars and keloids Age 12 and older
Exclusion criteria:
Pregnant Breastfeeding women Age less than 12 years history of allergy to the drugs used in the research liver and kidney disease Immune system deficiency Reduction in blood cell levels
Age
From 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 63
Randomization (investigator's opinion)
Randomized
Randomization description
This research is double-blinded experimental, interventional (clinical trial) study, in which researcher and patient are not aware of the treatment method, and patients would be distinguished with manual coding. The patients are then randomly assigned to three distinct groups randomly by a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
This research is double-blinded experimental, interventional (clinical trial) study, in which researcher and patient are not aware of the treatment method, and patients would be distinguished with manual coding.The checklist will be prepared by the executor and will be completed individually for each patient, and then the patients will be randomly assigned to three distinct groups randomly by random number table, and each step will be evaluated by assistant. Each method is performed by needle insertion after anesthesia which patient will be not aware of the material. The research is performed by executor and treatment response is analyzed by assistant.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2017-06-08, 1396/03/18
Ethics committee reference number
IR.TBZMED.REC.1396.193

Health conditions studied

1

Description of health condition studied
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
ICD-10 code
L99
ICD-10 code description
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Primary outcomes

1

Description
Scar Volume
Timepoint
Every 4 weeks, depending on the scar tissue, up to 6 sessions
Method of measurement
Using the vernier scale tool

Secondary outcomes

1

Description
Complications of treatment
Timepoint
Monthly, up to 6 months
Method of measurement
Clinical observation

Intervention groups

1

Description
Intervention group: The first group will be treated with Intra lesional cryotherapy(sarmadarman co./iran) alone.In this method, a liquid nitrogen at a temperature of -196 c through a probe leads to freezing of the lesion.Treatment every 4 weeks, depending on the scar tissue, will be repeated up to 6 sessions.
Category
Treatment - Other

2

Description
Intervention group 2: Triamcinolone 40 mg / ml will be injected by 27 gauge needle into the lesion in the amount of 0.2 ml / cm² (steroid used in this study is triamhexal.)Treatment every 4 weeks, depending on the scar tissue, will be repeated up to 6 sessions.
Category
Treatment - Drugs

3

Description
Intervention group3: 5Fluorouracil(EBEWE.CO) 250 mg / 5mg (0.2 ml / cm²) will be injected into the lesion by 27gauge needle.Treatment every 4 weeks, depending on the scar tissue, will be repeated up to 6 sessions.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology Clinic of Sina Hospital
Full name of responsible person
Dr.Hamideh Azimi
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3541 2103
Email
azimi@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Abolghasem Juiban
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
51386631357
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Tabriz University of Medical Sciences
Full name of responsible person
Hamide Azimi
Position
Dermatologist/Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
51386631357
Phone
+98 41 3553 9161
Email
azimi@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamide Azimi
Position
Dermatologist/Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, Sina Hospital, Azadi Ave. خیابان آزادی، بیمارستان سینا، بخش پوست
City
Tabriz
Province
East Azarbaijan
Postal code
51386631357
Phone
+98 41 3553 9161
Email
azimi@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamide Azimi
Position
Dermatologist/Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
51386631357
Phone
+98 41 3553 9161
Email
azimi@tbzmed.ac.ir

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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