Comparison of the combined therapeutic effect of mesotherapy and Fractional RF with mesotherapy alone in eliminating acne in the studied population based on ( age, gender, body mass index, patient satisfaction, doctor's consent)
Design
A clinical trial with an intervention and control group, with parallel groups, single blind, randomized, on 100 patients.
Settings and conduct
This study will be conducted in the form of a clinical trial in two intervention and control groups in a single-blind manner on patients with gout, referring to dermatology clinics affiliated to Tehran Islamic Azad University of Medical Sciences. Using the combination of mesotherapy and Fractional RF methods for the intervention group of 50 people on even days of the participants and the treatment of gout by mesotherapy only for the control group of 50 people on odd days.
Participants/Inclusion and exclusion criteria
Eligibility criteria: willingness to participate in the study; age between 18 and 60 years old; lack of skin sensitivity.
Exclusion criteria: existence of a known systemic disease affecting healing, such as type 2 diabetes; lack of consent to continue participating in the study; skin allergies when using the treatment; patients with underlying skin problems.
Intervention groups
Acne treatment using the combination of mesotherapy and Fractional RF for the intervention group of 50 people on even days and acne treatment by mesotherapy only for the control group of 50 people on odd days will be held in this study to treat acne with the mesotherapy method of Deoxy drug. Cholic acid and Scarlett device is used in fractional RF treatment.
Main outcome variables
Non-surgical treatment, creating a normal and beautiful appearance, avoiding the cost and complications of surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220615055190N1
Registration date:2022-07-11, 1401/04/20
Registration timing:prospective
Last update:2022-07-11, 1401/04/20
Update count:0
Registration date
2022-07-11, 1401/04/20
Registrant information
Name
Seyedeh sara Sarhadi podonak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2262 2877
Email address
sarayy.sarhadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Combined Therapeutic Effect of Mesotherapy and Fractional RF with Mesotherapy alone in eliminating Double Chin in Patients
Public title
Effect of Mesotherapy and RF laser in the Treatment of Double chin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to Participate in The Study
Age between 18 to 60 years old
Insensitivity of The skin
Exclusion criteria:
Existence of Known systemic disease Affecting repair such as type 2 diabetes
Dissatisfaction With continuing to participate in the study
Skin allergies when using the treatment
Patient with underlying skin problems
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple random. People were randomly divided into two intervention groups with the help of a random number table and witnesses will be divided.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study,the person responsible for data collection and the data saftey and monitoring committee are kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Azad University of Medical Sciences
Street address
No 61,West dolatshad Alley,Farid Afshar ST,Zafar Ave,Modares Highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1916618661
Approval date
2022-06-13, 1401/03/23
Ethics committee reference number
IR.IAU.TMU.REC.1401.070
Health conditions studied
1
Description of health condition studied
Treatment of Double chin
ICD-10 code
O32.3
ICD-10 code description
Maternal care for face, brow and chin presentation
Primary outcomes
1
Description
The amount of drooping under the chin (ghabghab) according to the checklist
Timepoint
At the beginning of the study, 90, 120 days later
Method of measurement
According to the changes made in the photo registration
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: combination of two methods of mesotherapy, which uses deoxycholic acid in 6 sessions every two weeks and fractional RF from the Scarlet machine, which uses radiofrequency waves with fractional technology in 4 sessions every one month.
Category
Treatment - Devices
2
Description
Control group: For the control group, only mesotherapy is performed, in which deoxycholic acid drug is used in 6 sessions every two weeks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Serare Tehrani
Street address
Front of Sardarjangal Park, Naziabad
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6061
Email
sarayy.sarhadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad hashemian
Street address
Tehran Azad Islamic University of Medical Sciences building, corner of Gol Yakh St., Dr. Shariati St
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
sarayy.sarhadi@gmail.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
seyede sara arhadi podonak
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 61, West dolatshad Alley, Farid Afshar St., Zafar Ave., Modares Highway
City
Tehran
Province
Tehran
Postal code
1916618661
Phone
+98 21 2262 2877
Email
sarayy.sarhadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyede Sara Sarhadi Podonak
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 61, West dolatshad Alley, Farid Afshar St., Zafar Ave., Modares Highway
City
Tehran
Province
Tehran
Postal code
1916618661
Phone
+98 21 2262 2877
Email
sarayy.sarhadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedeh Sara Sarhadi Podonak
Position
doctor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 61, West dolatshad Alley, Farid Afshar St., Zafar Ave., Modares Highway
City
Tehran
Province
Tehran
Postal code
1916618661
Phone
+98 21 2262 2877
Email
sarayy.sarhadi@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available