Evaluating the effectiveness of subcision in combination with Profhilo in comparison with subcision filler injection alone on acne scar among patients treated at the dermatology clinic
To determine the effect of Profhilo filler injection on atrophic acne scars in addition to subcision and comparing this to subcision alone.
Design
A clinical trial using both arm of case and control (each patient will be himself control) with 12 patient divided into two parallel groups by block randomization and blindness (the analyzing person).
Settings and conduct
the study will be ran in the Razi hospital, dermatologic operating room. the image analyser physician and the sonographist are single side blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
adults aging 18-40; presence of atrophic acne scar bilaterally; to be candida of subcision procedure; desire for participation after informed consent; no previous surgical procedure in the filed during last 3 months
Exclusion criteria:
previous filler injection at the site of procedure; hypercoagulablity disorder; any infection at the site of procedure; allergy to hyaluronic acid products; breast feeding and pregnancy; isotretinoin cosumption during last 6 months
Intervention groups
The intervention side of the face will undergone subcision and Profhilo injection subsequently and the control side of the face will only receive subcision.
All of these procedures will be repeated after 1 month.
Main outcome variables
Improvement grading of the lesions according to a dermatologist opinion;
Improvement grading of lesions according to ultrasonic evaluation;
Improvement scaling according to the patient opinion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201210049671N1
Registration date:2021-04-08, 1400/01/19
Registration timing:registered_while_recruiting
Last update:2021-04-08, 1400/01/19
Update count:0
Registration date
2021-04-08, 1400/01/19
Registrant information
Name
Mani Dastgheib
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8612 7032
Email address
mani.dastgheib@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-04, 1399/12/14
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of subcision in combination with Profhilo in comparison with subcision filler injection alone on acne scar among patients treated at the dermatology clinic
Public title
Effectiveness of Profhilo on Acne scar.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults aging between 18-40
Presence of bilateral atrophic acne scar
Being a potential candida for subcision procedure
Informed consent and patient agreement for participation
No previous procedure in last 3 months
Exclusion criteria:
Previous filler injection in the intervening site
Coagulation disorder
Autoimmune diseases
Infection at the site
Allergy to hyalouronic acid products
Pregnancy and breast feeding
Isotretinoin consumption during last 6 months
Age
From 18 years old to 40 years old
Gender
Both
Phase
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:
2
Each side of the faces will be considered in the case or control groups.
Randomization (investigator's opinion)
Randomized
Randomization description
the face of each individual will be designated to two sides of right and left and for a different procedure in each side. Any procedure will be done by block randomization using a software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients and the treating physician are aware about the side of procedures. But informations about the specific procedures on each side of the face will be withheld from the sonographist and final image analysers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee for Ethics in Biomedical Research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-07-07, 1398/04/16
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.293
Health conditions studied
1
Description of health condition studied
Atrophic acne scar
ICD-10 code
L70
ICD-10 code description
Acne
Primary outcomes
1
Description
Acne scar depth
Timepoint
At baseline and after 3 months
Method of measurement
Skin ultrasonography
2
Description
Total acne scar severity
Timepoint
At the base of study and after 3 months
Method of measurement
Photographic image analysis by dermatologist
3
Description
Acne severity based on self-assessment scoring
Timepoint
At the base of study and then after 3 months
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The randomized site of the face will undergone subcision and intradermal Profhilo filler injection, and will be repeated after 1 month.
Category
Treatment - Other
2
Description
Control group: The opposite side will undergone submission only and will be repeated after 1 month.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Vahideh Lajvardi
Street address
Vahdat Eslami street
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0174
Fax
+98 21 5563 4461
Email
razihospital@sina.tums.ac.ir
Web page address
http://razihos.tums.ac.ir/Home
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
6th Floor, Central Medical University Building, Qods street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
20
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
2
Sponsor
Name of organization / entity
IBSA Farmaceutici
Full name of responsible person
Armin ghaedi
Street address
Unit no. 1, 2nd floor, plaque no. 60, East Maryam street, Elahie
City
Tehran
Province
Tehran
Postal code
1964966335
Phone
+98 21 2204 4991
Email
info@paeezanco.com
Web page address
http://paeezanco.com/home
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Paeezan Tejarat Mehr
Proportion provided by this source
80
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
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamran Balighi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital, Razi alley, Vahdat Eslami Square
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0223
Email
kamran.balighi@yahoo.com
Web page address
http://razihos.tums.ac.ir/en/Home
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamran Balighi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital, Razi alley, Vahdat Eslami Square
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0223
Email
kamran.balighi@yahoo.com
Web page address
http://razihos.tums.ac.ir/en/Home
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mani Dastgheib
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Vahdat Eslami street
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 8612 7032
Fax
Email
Mani.dastgheib@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be accessible for academic researchers after covering the identities.
When the data will become available and for how long
After journal publishment, all data will be accessible for ever.
To whom data/document is available
For all academic researchers in the field of medicine and pharmacology.
Under which criteria data/document could be used
Just for using in research fields and respecting the original researchers in any references.
From where data/document is obtainable
Calling the main researchers using this email:
mani.dastgheib@gmail.com
What processes are involved for a request to access data/document
Just an email containing information about the academic position of the researchers and their responsibilities.