Determining the results of keloid treatment using a plasma device with or without triamcinolone injection in patients referred to the dermatology clinic of Islamic Azad University
Design
A randomized clinical trial study. two groups The first group was treated with a plasma plexer device without triamcinolone injection and the second group was treated with a plasma plexer device with triamcinolone injection
Settings and conduct
Coloid lesions are anesthetized by lidocaine gel and treated with triamcinolone injection along with plasma device with point-to-point method. The number of treatment sessions depends on the height of the keloid (about 2 to 5 sessions are required). The interval between treatment sessions is one month, and patients are followed up for recurrence and treatment complications up to 5 months after the last treatment session
At each visit, the recovery rate, possible treatment complications, and patient symptoms and complaints will be checked and recorded. Place in Dermatology Clinic of Islamic Azad University of Tehran
Participants/Inclusion and exclusion criteria
entry conditions
Age 18-70 years of both sexes
Informed consent to participate in the study
People who have the possibility of follow-up after treatment
People who have a keloid scar with a maximum height of 5 mm
Non-entry conditions
Pregnant or lactating patients and children under 15 years old
People who have a history of treatment at the site of the lesion in the last 6 months
People who have any underlying disease
Intervention groups
The first group will be considered for the treatment of skin lesion (keloid) with the plasmaplexer device without triamcinolone injection, and the second group will be considered for the skin keloid with the plasmaplexer device with triamcinolone injection
Main outcome variables
Keloid recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230801058997N1
Registration date:2024-06-27, 1403/04/07
Registration timing:retrospective
Last update:2024-06-27, 1403/04/07
Update count:0
Registration date
2024-06-27, 1403/04/07
Registrant information
Name
Amir Mohammad Barati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2263 5033
Email address
ambarati5277@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-08-28, 1402/06/06
Actual recruitment start date
2023-03-01, 1401/12/10
Actual recruitment end date
2023-08-28, 1402/06/06
Trial completion date
2023-08-28, 1402/06/06
Scientific title
Investigation of the Keloid treatment results using plasma device combined with or without triamcinolone injection
Public title
Investigation of the Keloid treatment results using plasma device combined with or without triamcinolone injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The minimum age is 18 and the maximum age is 70 years
Informed consent to participate in the study
People who have the possibility of follow-up after treatment
People who have a keloid scar with a maximum height of 5 mm
Exclusion criteria:
Pregnant or lactating patients and children under 15 years old due to the possible side effects of triamcinolone
People who have had a history of treatment at the site of the lesion in the last 6 months
People who have any type of underlying disease that affects wound healing
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a list of all patients who were willing to participate in the study was first prepared, and after matching the patients who met the inclusion criteria, we assigned a number to each patient. We considered numbers 1 to 10 as group A and 11 to 20 as group B. Then, using the online random numbers table, patients were placed in two groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2023-02-25, 1401/12/06
Ethics committee reference number
IR.IAU.TMU.REC.1401.371
Health conditions studied
1
Description of health condition studied
Keloid
ICD-10 code
L99.8
ICD-10 code description
Other specified disorders of skin and subcutaneous tissue in diseases classified elsewhere
Primary outcomes
1
Description
Keloid recovery
Timepoint
Between 2 and 5 sessions with an interval of one month
Method of measurement
doctor checkup
2
Description
Patient satisfaction
Timepoint
After treatment (after 2 to 5 sessions)
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treatment with plasma plexer device without triamcinolone injection.
Category
Treatment - Other
2
Description
Control group: treatment with plasma plexer device is performed with triamcinolone injection.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Sepideh Tehrani
Street address
At the beginning of Damāvand Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Majid Naqipour
Street address
Head Office of Islamic Azad University of Medical Sciences, Tehran, Ayene Boulevard, Nabsheh Giley Street, Amir Pabarja Street, Do Rahi Kolak, Dr. Shariati Street, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
tehrani42643@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Sepideh Tehrani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Head Office of Islamic Azad University of Medical Sciences, Tehran, Ayene Boulevard, Nabsheh Giley Street, Amir Pabarja Street, Do Rahi Kolak, Dr. Shariati Street, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
tehrani42643@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sepideh Tehrani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Head Office of Islamic Azad University of Medical Sciences, Tehran, Ayene Boulevard, Nabsheh Giley Street, Amir Pabarja Street, Do Rahi Kolak, Dr. Shariati Street, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
tehrani42643@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Mohammad Barati
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Head Office of Islamic Azad University of Medical Sciences, Tehran, Ayene Boulevard, Nabsheh Giley Street, Amir Pabarja Street, Do Rahi Kolak, Dr. Shariati Street, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
ambarati5277@gmail.com
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
We have no plans to share non-identifiable personal data of participants in this study