comparing the efficacy of intralesional injection of verapamil combined with cryotherapy versus intralesional injection of triamcinolone combined with cryotherapy in keloids and hypertrophic scars
Comparing the efficacy of intralesional injection of verapamil combined with cryotherapy versus intralesional injection of triamcinolone combined with cryotherapy in keloids and hypertrophic scars.
Design
Parallel groups (two lesions in one individual), randomized, single blind, 15 individuals, 30 lesions, clinical trial
Settings and conduct
In each session, cryotherapy and Triamcinolone will be used for one lesion of patient and cryotherapy and Verapamil for other lesion of the same patient. it repeats every 3 weeks up to 8 sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-70 years old; existence of at least two lesions in each individual.
Exclusion crieria: any infections around or near lesions; pregnant women; history of previous intra lesional treatment; patient's lack of consent for having the lesion pictured.
Intervention groups
The lesion is sterilized by alcohol pad, then local anesthesia of the lesion with 2% Lidocaine ampule is performed by the ring block method. After anesthesia, cryotherapy is performed by spraying. Performing cryotherapy is in the form of continuous spraying from a distance of 1 cm from the top of the lesion for 20 seconds. After 1 minute, an ampule triamcinolone 40 mg / ml is injected into a lesion and another lesion is injected by verapamil (5 mg / 2ml). Triamcinolone is half and half diluted with lidocaine and injected with an insulin syringe of 27 gauge, maximum of 60 mg per session. Verapamil is injected with an insulin syringe of 27 gauge and maximum of 5.3 mg per session. Injections are done at multiple points, to the extent that the lesion is completely blanched.
Main outcome variables
Main outcome measures include keloid and the score of vancouver scar scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180327039151N1
Registration date:2018-05-18, 1397/02/28
Registration timing:retrospective
Last update:2018-05-18, 1397/02/28
Update count:0
Registration date
2018-05-18, 1397/02/28
Registrant information
Name
Raya Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3624 6921
Email address
mokhtarir@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2017-11-22, 1396/09/01
Trial completion date
empty
Scientific title
comparing the efficacy of intralesional injection of verapamil combined with cryotherapy versus intralesional injection of triamcinolone combined with cryotherapy in keloids and hypertrophic scars
Public title
Comparing the efficacy of intralesional injection of verapamil combined with cryotherapy versus intralesional injection of triamcinolone combined with cryotherapy in keloids and hypertrophic scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-70 years old
At least two lesions in each patient
Exclusion criteria:
Any infection around or near lesions
Pregnant women
History of previous intra lesional treatment
Patient's lack of consent for having the lesion pictured
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
each individual has 2 keloids and hypertrophi scars
Actual sample size reached:
15
More than 1 sample in each individual
Actual sample size in each individual:
2
Each individual has 2 keloids and hypertrophi scars
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor: assessment of lesions by the co-worker is done. She is blind what medication is injected in each lesion.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2017-12-02, 1396/09/11
Ethics committee reference number
IR.SUMS.MED.REC.1396.93
Health conditions studied
1
Description of health condition studied
Hypertrophic scar
ICD-10 code
L91.0
ICD-10 code description
hypertrophic scar, verapamil, triamcinolone
Primary outcomes
1
Description
Score of keloid in Vancouver scar scale
Timepoint
Before intervention and 3, 6, 9, 12, 15, 18, 21, 24 weeks after intervention
Method of measurement
Vancouver scar scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: triamcinolone, amp 40mg/ml, made in Exir company Iran, maximum 60mg in each session, intralesional injection, every 3 weeks, 8 sessions
Category
Treatment - Drugs
2
Description
Intervention group 2: verapamil, ampule 5 mg/2ml, made in Hexal company Germany, maximum 3.5 mg in each session, intralesional injection, every 3 weeks, 8 sessions
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi clinic
Full name of responsible person
Nasrin Saki
Street address
Zand Blvd, Shahid Faghihi clinic
City
Shiraz
Province
Fars
Postal code
7187711419
Phone
+98 71 3624 6921
Email
nasrinsa85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seied Basir Hashemi
Street address
Faghihi hospital , Zand st , Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Saki
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Faghihi hospital ;Zand st
City
Shiraz
Province
Fars
Postal code
7187711419
Phone
+98 71 3624 6921
Email
nasrinsa85@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Saki
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Faghihi Hospital ; Zand st
City
Shiraz
Province
Fars
Postal code
7187711419
Phone
+98 71 3624 6921
Email
nasrinsa85@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Raya Mokhtari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Faghihi Hospital ; Zand st
City
Shiraz
Province
Fars
Postal code
7187711419
Phone
+98 71 3624 6921
Email
mokhtari.raya@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