Comparison of efficacy of " Botulinium Toxin A plus Triamcinolone" intralesional injection with intralesional injection of Triamcinolone alone for treatment of keloid
The goal of this study is the comparison of Botolinium toxin A plus triamcinolon with triamcinolone alone for treatment of keloid.This study is single blined.Patients should have at least two keloids and they should not be pregnant or breast feeding.Sample size is 20 patients.Two distinct lesions will go under one of theese treatments(after general anesthesia):1-Intralesional injection of triamcinolon 2-Intralesional injection of triamcinolone+BTA.Treatment will be contineud monthly for 3 monthes.At each treatment session the height,consistency,pigmentation and vascularisation of keloids will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071918533N1
Registration date:2014-08-11, 1393/05/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-11, 1393/05/20
Registrant information
Name
Nasibe Sohrabian
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 661 3067
Email address
sohrabian.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
neuronox company
Expected recruitment start date
2014-08-01, 1393/05/10
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of " Botulinium Toxin A plus Triamcinolone" intralesional injection with intralesional injection of Triamcinolone alone for treatment of keloid
Public title
Assessment of efficacy of Botulinium toxin A for treatment of keloid
Purpose
Treatment
Inclusion/Exclusion criteria
]nclusion criteria:patients should have at least too keloids on the skin ;age between 15 and 45 years
Exclusion criteria:pregnant or breast feeding women ;neuromuscular jaunction diseases or receiving neuromuscular junction blocker agents
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University, Daneshgah Sq, Ahvaz, Iran
City
Ahvaz
Postal code
61357-15794
Approval date
2014-04-09, 1393/01/20
Ethics committee reference number
ajums.REC.1393.143
Health conditions studied
1
Description of health condition studied
keloid scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Height of keloid
Timepoint
Before treatment ond 1 month after end of treatment
Method of measurement
Caliper in milimeters
2
Description
Consistency of keloid
Timepoint
Before treatment ond 1 month after end of treatment
Method of measurement
Physical examination score 1-5
3
Description
Vascularity
Timepoint
Before treatment ond 1 month after end of treatment
Method of measurement
Physical examination score 1-3
4
Description
Pigmentation
Timepoint
Before treatment ond 1 month after end of treatment
Method of measurement
Physical examination score 1-3
5
Description
Pain
Timepoint
Before treatment ond 1 month after end of treatment
Method of measurement
Subjective scale of pain:score 1-10
6
Description
Itch
Timepoint
Before treatment ond 1 month after end of treatment
Method of measurement
Subjective scale of itch:score 1-10
Secondary outcomes
1
Description
skin atrophy
Timepoint
1 month after end of treatment
Method of measurement
yes or no
Intervention groups
1
Description
Triamcinolone intralesional injection 20mg/ml monthly for 3 months
Category
Treatment - Drugs
2
Description
Triamcinolone intralesional injection 20mg/ml+Botulinum toxin A 20u/ml intralesional injection monthly for 3months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital of Ahvaz
Full name of responsible person
Dr Sima Rasaii
Street address
Dermatology department of Imam Khomeini hospital, Azdegan Av, Ahvaz, Iran