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Comparison of the effect of BTWT1, Btvita and LeishG1 topical products with zinc oxide ointment (standard drug) on skin wound healing

Protocol summary

Study aim
Comparison of the effect of BTWT1, Btvita and LeishG1 topical products with zinc oxide ointment (standard drug) on ​​skin wound healing in patients undergoing microneedling and laser rejuvenation
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 144 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The participants start using the drug after performing a bilateral surgery for cosmetic procedures In the office of a dermatologist and no additional operations were imposed on them for this study. Zinc oxide ointment and BTWT1, Btvita and LeishG1 drugs are given to patients in similar and coded containers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Performing micro-needling or laser rejuvenation procedures and having two similar wounds. Exclusion criteria: Suffering from diseases that affect wound healing, regular use of medications or treatments effective in wound healing (such as anticoagulants, non-steroidal anti-inflammatories, topical steroids, suffering from immunodeficiency diseases, peripheral vascular disease, history of keloid formation, and those who receive anticoagulant treatment or systemic corticosteroids.
Intervention groups
Group 1: 48 patients with bilateral wounds, treatment with topical BTWT1 cream on one wound and zinc oxide ointment on the other wound for ten days. Group 2: 48 patients with bilateral wounds, treatment with topical Btvita cream on one wound and zinc oxide ointment on the other wound for ten days. Group 3: 48 patients with bilateral wounds, treatment with topical LeishG1 cream on one wound and zinc oxide ointment on the other wound for ten days.
Main outcome variables
Intensity and duration for parameters of pain (discomfort), exudation, erythma, scaling and epithelialization based on visual analog scale (VAS)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240304061158N2
Registration date: 2024-07-23, 1403/05/02
Registration timing: registered_while_recruiting

Last update: 2024-07-23, 1403/05/02
Update count: 0
Registration date
2024-07-23, 1403/05/02
Registrant information
Name
fariba nemati
Name of organization / entity
Behpad Teb Iranian
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 6890
Email address
info@behpadti.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of BTWT1, Btvita and LeishG1 topical products with zinc oxide ointment (standard drug) on skin wound healing
Public title
Comparison of the effect of BTWT1, Btvita and LeishG1 topical products on skin wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Performing microneedling or laser rejuvenation procedures and having two similar and bilateral wounds
Exclusion criteria:
Suffering from diseases that affect wound healing (such as eczema, psoriasis, anemia or diabetes) Regular use of medications or treatments effective in wound healing (such as anticoagulants, non-steroidal anti-inflammatories, topical steroids). Suffering from immunodeficiency diseases, peripheral vascular disease, history of keloid formation, and those who receive anticoagulant treatment or systemic corticosteroids.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 144
More than 1 sample in each individual
Number of samples in each individual: 2
A wound on the face
Randomization (investigator's opinion)
Randomized
Randomization description
After identifying the eligible people, the participants will be randomized into 3 study groups using the randomization method based on block randomization. In this way, 3 blocks are formed by combining codes A, B, C related to intervention groups 1 to 3. Then the blocks will be randomly selected based on the rand function from Excel until the final volume of the sample is reached. Grouping is done by determining 144 non-transparent envelopes, which have the group number on the envelope and the type of intervention and the left and right sides of the intervention and zinc oxide medicine.
Blinding (investigator's opinion)
Double blinded
Blinding description
BTWT1, Btvita and LeishG1 topical products and zinc oxide ointment are all packaged in similar packaging that cannot be separated from each other and coded with randomized codes and provided to the project manager.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2024-01-08, 1402/10/18
Ethics committee reference number
IR.SHAHED.REC.1402.133 کد مصوبه اخلاق:

Health conditions studied

1

Description of health condition studied
Skin wound repair in patients undergoing microneedling and laser rejuvenation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain in wound site
Timepoint
3rd, 7th, 14th, 21nd days after starting the study
Method of measurement
Visual Analogue Scale

2

Description
Erythma
Timepoint
3rd, 7th, 14th, 21nd days after starting the study
Method of measurement
Visual Analogue Scale

3

Description
exudation
Timepoint
3rd, 7th, 14th, 42nd and 84th days after starting the study
Method of measurement
Visual Analogue Scale

4

Description
Scaling
Timepoint
3rd, 7th, 14th, 42nd and 84th days after starting the study
Method of measurement
Visual Analogue Scale

5

Description
Epithelialization
Timepoint
3rd, 7th, 14th, 42nd and 84th days after starting the study
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
safety
Timepoint
3rd, 7th, 14th, 21nd days after starting the study
Method of measurement
Doctor examination and patient report

2

Description
beauty appearance
Timepoint
30 and 60 days after starting the study
Method of measurement
Visual Analogue Scale

Intervention groups

1

Description
Intervention group 1: After the surgery in the dermatology and hair specialist's office, which was performed bilaterally, the participants applied the product Btvita manufactured by Behpad Teb Iranian Company on the wound on one side of their face twice a day one fingertip unit for ten days. And on the other side of the face, they use zinc oxide ointment as a control twice a day one fingertip unit for ten days. Both ointments are provided to the patient in the same pack, coded and blinded.
Category
Treatment - Drugs

2

Description
Intervention group 2: After the surgery in the dermatology and hair specialist's office, which was performed bilaterally, the participants applied the product BTWT1 manufactured by Behpad Teb Iranian Company on the wound on one side of their face twice a day one fingertip unit for ten days. And on the other side of the face, they use zinc oxide ointment as a control twice a day one fingertip unit for ten days. Both ointments are provided to the patient in the same pack, coded and blinded.
Category
Treatment - Drugs

3

Description
Intervention group 3: After the surgery in the dermatology and hair specialist's office, which was performed bilaterally, the participants applied the product LeishG1 manufactured by Behpad Teb Iranian Company on the wound on one side of their face twice a day one fingertip unit for ten days. And on the other side of the face, they use zinc oxide ointment as a control twice a day one fingertip unit for ten days. Both ointments are provided to the patient in the same pack, coded and blinded.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Khodashenas dermatology clinic
Full name of responsible person
Khodashenas Zohreh
Street address
BRT 32th station, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1418863981
Phone
+98 903 111 9779
Email
zohrehkhodashenas@ymail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Behpad Teb Iranian
Full name of responsible person
Fariba Nemati
Street address
Tehran, 20th km of Damavand Road, Pardis Technology Park, Danesh 4, Fanavaran Bldg, Unit 22
City
Pardis
Province
Tehran
Postal code
1654120611
Phone
+98 21 6642 6890
Fax
+98 21 4066 0468
Email
info@behpadti.com
Web page address
https://behpadti.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behpad Teb Iranian
Proportion provided by this source
85
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
Industry

2

Sponsor
Name of organization / entity
Shahed university Immune Response Regulation Research Center
Full name of responsible person
Azade Rashidi
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Fax
+98 21 6641 9752
Email
immunoreg@shahed.ac.ir
Web page address
https://irrc.shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed university Immune Response Regulation Research Center
Proportion provided by this source
15
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
Immunoregulation Research Center
Full name of responsible person
Azadeh Rashidi
Position
Project coordinator
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Fax
+98 21 6641 9752
Email
a.rashidi@shahed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin clinic of Dr. Khodashenas
Full name of responsible person
Zohreh Khodashenas
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Station 32, Valiasr Street.
City
Tehran
Province
Tehran
Postal code
1418863981
Phone
+98 903 111 9779
Email
zohrehkhodashenas@ymail.com

Person responsible for updating data

Contact
Name of organization / entity
Immunoregulation Research Center
Full name of responsible person
Azadeh Rashidi
Position
master of science
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Fax
+98 21 6641 9752
Email
a.rashidi@shahed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Ethical consideration about patient information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After publishing the final results, the study protocol, statistical analyzes and the informed consent form will be shared without mentioning the names of the individuals.
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Domestic researchers
Under which criteria data/document could be used
To conduct review studies or advanced statistical analysis and bioinformatics
From where data/document is obtainable
Azadeh Rashidi (project coordinator-Immunoregulation research center-Shahed university)
What processes are involved for a request to access data/document
Submitting a request to the executor of the project, Mrs. Dr. khodashenas,Referral to the head of the center Shahed University research, Obtain university approval,Provision of data
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