Efficacy and safety of plasma jet in periorbital rejuvenation in patients visiting the dermatology clinic of the Shohada-e Tajrish hospital
Design
non-blinded interventional study
Settings and conduct
A non-blinded intervention study will be carried out in Shohada-e Tajrish hospital ,for people with blepharo laxity with the aim of periorbital rejuvenation with the plasma jet and then will be evaluated with a comparison of their clinical images and the reviscometery results.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People with complaint of belpharolaxity
Exclusion criteria:
Unwillingness to participate in the study
age<35 year old
History of skin infections
History of neuromuscular disease
uncontrolled diabetes melitus
Immunsuppressant drugs
pregnant or lactating females
Intervention groups
patients fulfilling the study inclusion criteria will be provided with all the information concerning the procedure and informing the research properties of the treatment. Patients will be asked to sign written consent. An expert dermatologist will evaluate all participants in this field before starting the study. After a local anesthetics cream (Lidocaine cream), the patient will be asked to wait for thirty minutes for the skin to be numbed. Before beginning the treatment, one must ensure that the skin surface is wiped clean of any local anesthetics cream. The plasma will be used first on the right eyelid and then left eyelid. These procedures will be repeated in three sessions in monthly intervals. Participants will be evaluated before treatment and one month and three months after the last treatment to evaluate the effectiveness of the treatment
Main outcome variables
Evaluation of periorbital rejuvenation
Evaluation of the patient satisfaction
Adverse effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190407043192N1
Registration date:2019-07-23, 1398/05/01
Registration timing:retrospective
Last update:2019-07-23, 1398/05/01
Update count:0
Registration date
2019-07-23, 1398/05/01
Registrant information
Name
Maryam Beheshti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 9201
Email address
ma_beheshti@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of plasma jet in periorbital rejuvenation & palpebral laxity
Public title
periorbital rejuvenation& palpebral laxity with plasma jet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with chief complaint of palpebral laxity
People with 35-65 years old
Exclusion criteria:
Unwillingness to participate to the study
History of skin infections such as herpes simplex
History of neuromuscular or connective tissue diseases
Uncontrolled diabetes melitus
Immunosuppressant drugs
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ُSkin Research Center, Shahid Beheshti University of Medical Sciences
Street address
Skin Research Center, Shohada-e Tajrish Hospital- Shahrdari St.-Qods Square
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2018-12-09, 1397/09/18
Ethics committee reference number
IR.SBMU.SRC.REC.1397.016
Health conditions studied
1
Description of health condition studied
Periorbital rejuvenation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of periorbital rejuvenation : no response (<10%), mild response (10-25%), moderate response (25-75%), excellent response (>75%)
Timepoint
Before treatment ,one month after each treatment session , three months after the last treatment session
Method of measurement
Clinical images , Reviscometer device
Secondary outcomes
1
Description
Evaluation of the patient satisfaction
Timepoint
Before treatment, one month after each treatment session ,three months after the last treatment session
Method of measurement
Based on the patient response to the question (unsatisfactory , partial satisfaction , totally satisfied)
2
Description
Advers effects
Timepoint
Before treatment, one month after each treatment session ,three months after the last treatment session
Method of measurement
Based on the patient response to the question (infection , erythema , post inflammatory hyper or hypo pigmentation)
Intervention groups
1
Description
Intervention group: patients fulfilling the study inclusion criteria will be provided with all the information concerning the procedure and informing the research properties of the treatment. Patients will be asked to sign written consent. An expert dermatologist will evaluate all participants in this field before starting the study. After a local anesthetics cream (Lidocaine cream), the patient will be asked to wait for thirty minutes for the skin to be numbed. Before beginning thevtreatment, one must ensure that the skin surface is wiped clean of any local anesthetics cream. The plasma will be used first on the right eyelid and then left eyelid. These procedures will be repeated in three sessions in monthly intervals. Participants will be evaluated before treatment and one month and three months after the last treatment to evaluate the effectiveness of the treatment.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Shohada-e Tajrish Hospital
Full name of responsible person
Hamideh Moravvej
Street address
Shohada-e Tajrish Hospital, Shahrdari St. Qods Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Email
ma_beheshti@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Hamideh Moravvej
Street address
Shohada-e Tajrish Hospital,Shahrdari St. Qods Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Fax
+98 21 2274 4393
Email
hamidehmoravej@sbmu.ac
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Beheshti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shohada-e Tajrish Hospital -Shahrdari St. Qods Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Email
ma_beheshti@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fahimeh Abdollahimajd
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shohada-e Tajrish Hospital -Shahrdari St. Qods Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Email
fabdollahimajd@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Beheshti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shohadaye Tajrish Hospital-Shahrdary St. Qods Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Email
ma_beheshti@yahoo.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
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
Undecided - It is not yet known if there will be a plan to make this available