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Evaluation of the efficacy, safety, satisfaction and tolerability of treatment with diluted botulinum toxin A in comparison with intralesional triamcinolone in patients undergone PDL laser for Hypertrophic erythematous scars: A blinded randomized controlled clinical trial

Protocol summary

Study aim
Evaluation of efficacy, safety, satisfaction and tolerability of treatment of erythematous hypertrophic scars by injection of diluted botulinum toxin type A in comparison with triamcinolone injection in patients undergoing PDL laser treatment
Design
Clinical trial with 3 intervention groups, blinded, parallel, randomized, phase 2-3 on 12 patients, randomized by Excel software
Settings and conduct
Patients referred to Hazrat Fatemeh Hospital Laser Clinic with at least 3 hypertrophic erythematous scar lesions will randomly receive one of the following treatments for each lesion: 1. PDL laser (control) 2. PDL laser with botulinum toxin type A. 3. PDL laser with intralesional triamcinolone. In the second and third sessions, all lesions will be treated only with PDL laser and in the fourth session, the lesions will be followed up without any intervention. In each session, all lesions will be imaged. The study will be done as a single blind study. The results of the studies will be evaluated by a blind dermatologist based on the images prepared from the lesions in each session and also the data analysis will be done by a blind statistical expert.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Hypertrophic erythematous scars of at least 3 2. The size of the lesions should be at least 10 × 10 cm2 or have a length of at least 10 cm. 3. The patient has not received any treatment for the lesions in the last two months. Exclusion criteria: Occurrence of allergies or any side effects
Intervention groups
1. PDL laser treatment (control group) 2. PDL laser treatment with injection of diluted botulinum toxin type A. 3. PDL laser treatment with intralesional injection of triamcinolone
Main outcome variables
Effectiveness of treatment using Vancouver scar scale (VSS) scoring method

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220121053776N1
Registration date: 2022-02-16, 1400/11/27
Registration timing: prospective

Last update: 2022-02-16, 1400/11/27
Update count: 0
Registration date
2022-02-16, 1400/11/27
Registrant information
Name
Mohammad Amin Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2390
Email address
jafari.mam@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy, safety, satisfaction and tolerability of treatment with diluted botulinum toxin A in comparison with intralesional triamcinolone in patients undergone PDL laser for Hypertrophic erythematous scars: A blinded randomized controlled clinical trial
Public title
Comparison of the efficacy of botulinum toxin and triamcinolone in patients with hypertrophic scars treated with PDL laser
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years Patients with a confirmed diagnosis of hypertrophic erythematous scars of at least 3 The size of the mentioned lesions should be at least 10 × 10 cm or have a length of at least 10 cm The patient is not pregnant or breast feeding The patient has not received any treatment for lesions such as laser, topical or injectable corticosteroids in the past two months The patient has no underlying diseases that lead to the healing process of the scar; Such as diabetes or weakened immune system The patient's cooperation in performing medical interventions and referring to all treatment sessions
Exclusion criteria:
Occurrence of pregnancy during treatment or follow-up period The occurrence of allergies or any side effects to one of the therapeutic interventions that prevent further treatment Diagnosis of malignancy or systemic disease during treatment or follow-up period The appearance of bacterial or viral skin diseases during treatment or follow-up
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 12
More than 1 sample in each individual
Number of samples in each individual: 3
The sample size was a total of 34, considering that the patients are divided into three groups, 12 cases will be placed in each group. Equivalently, considering that in this study patients with at least 3 lesions were included and for the lesions of each patient one of the mentioned treatment methods will be performed randomly, in this study a total of 36 lesions (12 lesions in each group), In other words, 12 patients will be included.
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple randomization method, patients' lesions are divided into 3 groups, so that out of 36 sealed envelopes, one envelope is randomly selected for each lesion. Inside each envelope is the letter A or B or C.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the clear difference between the mentioned therapeutic interventions, it is not possible to blind the therapist and patients and the study will be performed as a single blind study. The data will be evaluated by a blind evaluator based on the images prepared from the lesions in each session and also the data analysis will be done by a blind statistical expert.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of medical scinces
Street address
Hazrat Rasool Akram hospital, Mansoori avenue, Sattarkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2021-11-16, 1400/08/25
Ethics committee reference number
IR.IUMS.FMD.REC.1400.487

Health conditions studied

1

Description of health condition studied
Hypertrophic erythematous scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar

Primary outcomes

1

Description
Effectiveness of treatment
Timepoint
Three months after the first treatment session
Method of measurement
By using Vancouver scar scale (VSS) scoring method

Secondary outcomes

1

Description
Safety
Timepoint
One, two and three months after the first treatment session
Method of measurement
Questions about possible side effects of treatment

2

Description
Tolerability
Timepoint
One, two and three months after the first treatment session
Method of measurement
Question from the patient

3

Description
Satisfaction
Timepoint
One, two and three months after the first treatment session
Method of measurement
Based on patient scoring

Intervention groups

1

Description
Control group: Treatment with PDL: Before the intervention, cleaning the lesion by using normal saline impregnated gas will be done. Then, 60 minutes before laser treatment, a local anesthetic cream containing lidocaine 2.5% and prilocaine 2.5% (Xyla-P, Tehran Chemie, Tehran, Iran) will be applied to the lesion. At the end of 60 minutes, the local anesthetic cream will be removed using an alcohol swab. Then PDL laser using Alexandrite Deca laser device (Synchro VasQ, Deka, Florence, Italy) with a pulse of 595 nm, spot size 7 mm, single duration of half a millisecond and power of 6.5 J / cm2 with 100 shots per area A 10 × 10 cm square lesion will be applied. PDL laser will be applied in all treatment groups and in the first three sessions.
Category
Treatment - Devices

2

Description
Intervention group 1: PDL treatment with injection of diluted botulinum toxin type A: In the second group, in addition to the PDL laser, in the first session, the injection of botulinum toxin type A of Dysport manufacturer (Speywood Pharmaceuticals Ltd., Maidenhead, UK) will be performed in diluted form immediately after laser treatment. Each vial contains Clostridium botulinum toxin type A hemoglutin complex with 125 micrograms of human albumin and 2.5 mg of lactose. Each vial has 500 units of dysport and dilution will be performed in 2.5 ml of normal saline to achieve a concentration of 200 units per ml. The toxin will then be injected at a dose of 2.5 units per cubic centimeter into the lesion, so that the total number of units injected into each lesion does not exceed 100 units.
Category
Treatment - Other

3

Description
Intervention group 2: PDL treatment with intralesional injection of triamcinolone: In the third group, in addition to PDL laser, in the first session, intralesional triamcinolone will be performed immediately after laser treatment. For this purpose, 40 mg / 1 triamcinolone ampoule is used (Exir Co., Tehran, Iran) which is diluted with 2% lidocaine solution (Xylopen, Exir co., Tehran, Iran) in equal volume and in a concentration of 20 Mg in 1 ml will be used. Finally, 1 ml (20 mg of triamcinolone) per 100 cm 2 of the lesion will be injected.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatemeh hospital
Full name of responsible person
Najmossadat Atefi
Street address
Hazrat Fatemeh hospital, 21st street, Asadabadi street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3311114339
Phone
+98 21 8871 7272
Email
Atefi_roshan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Najmossadat Atefi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 7341
Email
Atefi_roshan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Najmossadat Atefi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 7341
Email
Atefi_roshan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Amin Jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Hazrat Rasool Akram hospital, Mansoori avenue, Sattarkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2390
Fax
Email
jafari.mam@iums.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
Not applicable
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