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To evaluate the safety and efficacy of M3D Fractional - Made By Medaria in reducing facial aging: A single arm phase III clinical trial

Protocol summary

Summary
This is a single-arm phase III clinical trial will be performed on 15 subjects who are undergoing skin rejuvenation at Center for Research & Training Skin Diseases& Leprosy, Tehran University of Medical Sciences, Tehran, Iran. Each patient will be received six sessions of m3D Fractional treatment to the whole face. The face will be thoroughly cleaned and dried before treatment. Treatment will be conducted by trained and experienced technician according to the instructions in m3D Fractional user manual. All subjects will be asked to return for follow-up 1 week, 3 months and 6 months after their final treatment session. Digital photographs will be taken by VisioFace and subjects will be assessed for the degree of wrinkles and laxity at baseline and follow-up visits (1week, 3 months and 6 months after their final treatment session). Also Cutometer, Corneometer, TEWAmeter, Mexameter, and ultrasonographic measurements will be determined at baseline and follow-up visits. Subjects will rate overall satisfaction based on a 6-point Likert scale (0-No satisfaction, 1- very little satisfaction, 2-little satisfaction, 3-moderate satisfaction, 4-much satisfaction, 5- very much satisfaction) after the final treatment session and at follow-up visits.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201507226135N5
Registration date: 2015-07-24, 1394/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Hamed Hosseini
Name of organization / entity
Clinical Trial Center (CTC),Tehran University of Medical Sciences (TUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 3546
Email address
hhosseini@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Medaria company
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the safety and efficacy of M3D Fractional - Made By Medaria in reducing facial aging: A single arm phase III clinical trial
Public title
To evaluate the safety and efficacy of M3D Fractional - Made By Medaria in reducing facial aging
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: • Aged between 30 to 60 years. • Mild to moderate (Glogaue Score) • Skin Type (II-IV) • Signed informed consent voluntarily and knowingly Exclusion criteria • History of any implant in face area • History of any cosmetic surgery during last 3 years in face area • History of RF during last year • History of any Botulinum, laser, or intense pulsed light during last 6 month • History of Isotretinoin during last 6 month • Collagen vascular disease • Diabetes • Severe cardiac disease • Malignant tumor • Bleeding disorders, Coagulopathy, any drugs affect bleeding time • Any active, chronic and recurrent infection • Any history of anaphylaxis • Susceptibility to keloids • Any active or recurrent herpes • Any immune-compromised conditions • Skin atrophy • Active smoker ( last 2 years) • Pregnancy/ breast feeding • Vascular disease • Cardiac pace maker • Vertigo, labyrinthitis • Dyslipidemia
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2015-07-04, 1394/04/13
Ethics committee reference number
IR.TUMS.REC.1394.324

Health conditions studied

1

Description of health condition studied
Facial aging
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
wrinkle
Timepoint
At baseline- 1 week, 3 months and 6 months after the last treatment session
Method of measurement
Two board-certified dermatologists will perform clinical assessments in a blinded fashion by scoring every photograph according to the Fitzpatrick wrinkle scale

2

Description
laxity
Timepoint
At baseline- 1 week, 3 months and 6 months after the last treatment session
Method of measurement
Two board-certified dermatologists will perform clinical assessments in a blinded fashion by scoring every photograph according to the Alexiades-Armenakas laxity scale

Secondary outcomes

1

Description
Patient's overall satisfaction
Timepoint
At the final treatment session and at 1-week, 3- month and 6- month after their final treatment session
Method of measurement
based on a 6-point Likert scale (0-No satisfaction, 1- very little satisfaction, 2-little satisfaction, 3-moderate satisfaction, 4-much satisfaction, 5- very much satisfaction)

2

Description
Skin elasticity
Timepoint
At baseline and 1-week, 3- month and 6-month after the final treatment session
Method of measurement
Cutometer

3

Description
Water content
Timepoint
At baseline and 1-week, 3- month and 6-month after the final treatment session
Method of measurement
Corneometer

4

Description
Transepidermal water loss
Timepoint
At baseline and 1-week, 3- month and 6-month after the final treatment session
Method of measurement
TEWAmeter

5

Description
Skin pigmentation
Timepoint
At baseline and 1-week, 3- month and 6-month after the final treatment session
Method of measurement
Mexameter

6

Description
Ultrasonographic measurements ( skin thickness and density)
Timepoint
At baseline and 1-week, 3- month and 6-month after the final treatment session
Method of measurement
Skin ultrasonography

7

Description
wrinkles and colour differences
Timepoint
At baseline and 1-week, 3- month and 6-month after the final treatment session
Method of measurement
VisioFace

8

Description
Side-effects including erythema, edema, pain, hyperpigmentation and scarring)
Timepoint
All visits
Method of measurement
By physician

Intervention groups

1

Description
Each patient will receive six sessions of m3D Fractional treatment to the whole face. The face will be thoroughly cleaned and dried before treatment. Treatment will be conducted by trained and experienced technician according to the instructions in m3D Fractional user manual. All subjects will be asked to use sunscreen with SPF 30 after each treatment session and to visit 1-week, 3- and 6-month after the last treatment session.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for Research & Training in Skin Diseases & Leprosy
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Medaria Company
Full name of responsible person
Dr.Arash Rezaei
Street address
Unit 5 ,No 57,Rajian St Gooyabadi St,Zafar St, Shariati St T
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medaria Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences
Full name of responsible person
Dr. Alireza Firooz
Position
MD, Prof. of Dermatology
Other areas of specialty/work
Street address
No. 415, Taleqani Ave.
City
Tehran
Postal code
Phone
+98 21 8897 2220
Fax
Email
firozali@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Clinical Trial Center (CTC), Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr. Leila Janani
Position
Phd in biostatistics
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 8896 3546
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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