Comparison of clinical efficacy of intra- leisonal TriamHexal with and without Anti-VEGF(Bevacizumab) in treatment of keloid lesions
Design
A simple randomized clinical trial (phase 3) (using random allocation software) with control group (parallel groups) and double blinded on 40 patients with keloid lesions enrolled between 2019-2020.
Settings and conduct
This study is performed on patients with keloidal lesions referred to dermatology clinics of Isfahan University of Medical Sciences. A keloidal lesion in each individual is selected randomly. One group will receive intralesional Triamhexal injection and the other group (intervention group) will receive intralesional Avastin in addition to Triamhexal injection.The patients will be evaluated for outcomes and side effects. Patient and service provider are unaware of the type of medication given to the patient (double blinded).
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least 1 keloidal lesion in the trunk and extremities; age 18 to 70 years old; Informed consent to participate in the study.
Exclusion criteria: pregnancy; breastfeeding; history of cardiovascular diseases; unwillingness to continue treatment; not following up; patients with severe side effects; patients who have had previous keloid therapy; infection at the injection site.
Intervention groups
Intervention group: intralesional administration of 20 mg/dl TriamHexal plus 2/5 mg/dl intralesional Avastin (/1 cc to 1cc from vial of Avastin). Control group: administration of 20 mg/dl intralesional TriamHexal.
Main outcome variables
Improvement rate according to physician's point of view; patient satisfaction score; treatment side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131119015455N5
Registration date:2020-02-10, 1398/11/21
Registration timing:registered_while_recruiting
Last update:2020-02-10, 1398/11/21
Update count:0
Registration date
2020-02-10, 1398/11/21
Registrant information
Name
Bahareh Abtahi-Naeini
Name of organization / entity
Skin Diseases and leishmaniasis research Center, Isfahan University of Medical Sciences, Isfahan, Ir
Country
Iran (Islamic Republic of)
Phone
+98 31 1264 2901
Email address
bahareh.abtahi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of clinical efficacy of intra- leisonal TriamHexal with and without Anti-VEGF(Bevacizumab) in treatment of keloidal leisons
Public title
Efficacy of TriamHexal with and without Anti-VEGF(Bevacizumab) in treatment of keloidal leisons
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 1 keloidal lesion in the trunk and extremities
Age 18 to 70 years old
Informed consent to participate in the study
Exclusion criteria:
Pregnancy
Breastfeeding
History of cardiovascular diseases
Unwillingness to continue treatment
Not following up
Patients with severe side effects
Patients who have had previous keloid therapy
Infection at the injection site
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
A keloidal lesion in each individual is selected randomly using simple randomization by Random Allocation Software. One group will receive intralesional Triamhexal injection and the other group (intervention group) will receive intralesional Avastin in addition to Triamhexal injection.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blinded study in which the patient and service provider are unaware of the type of medication given to the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Research and Technology Deputy of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.MUI.MED.REC.1398.163
Health conditions studied
1
Description of health condition studied
Keloidal lesions
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Improvement rate according to physician's point of view
Timepoint
4, 8, 12 weeks and then 3 months after intervention
Method of measurement
Vancuver score and photography assessment by two blinded dermatologists.
2
Description
Patient satisfaction score
Timepoint
3 months and 6 months after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Treatment side effects
Timepoint
2 days after of each injection
Method of measurement
After the patient is instructed about possible side effects, the patient will be consulted by telephone to refer to the physician in case of severe side effects.
Intervention groups
1
Description
Intervention group: Administration of 20 mg/dl intralesional TriamHexal (made in Germany) at weeks 0, 4, and 8 and administration of 2/5 mg/dl intralesional Avastin (made in Switzerland) (/1 cc to 1cc from vial of Avastin) at weeks 2 and 6.
Category
Treatment - Drugs
2
Description
Control group: Administration of 20 mg/dl intralesional TriamHexal (made in Germany) at weeks 0, 4, and 8