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Evaluation of safety and efficacy of INOVOSENSE MESOCELL PLUS mesogel for improvement of face skin elasticity and rejuvenation

Protocol summary

Study aim
Evaluation of safety and efficacy of INOVOSENSE MESOCELL PLUS mesogel for improvement of face skin elasticity and rejuvenation
Design
An interventional, randomized, non-blinded, non-placebo, single-study, treatment-intent, phase 2 clinical trial on 20 patients.
Settings and conduct
This clinical trial will be conducted at the Razi Hospital Dermatology Clinic and the Skin Diseases and Leprosy Education and Research Center. For each person, 2 ml of MESOCELL PLUS injectable mesogel will be done in 2 sessions, 1 month apart. Then, the improvement in skin quality is assessed before the intervention and 4 weeks after the last injection based on digital before-and-after photography, measurement of skin elasticity by cutometery, and examination of the signs of skin aging, including facial lines and wrinkles, using the GAIS scale. Also, to determine the level of effectiveness, patients' photos are reviewed by two dermatologists, and patient satisfaction and possible side effects are recorded at each visit.
Participants/Inclusion and exclusion criteria
25 -60 Years women and men with visible signs of skin aging such as reduced skin elasticity and the presence of lines and wrinkles, without a history of any cosmetic procedure in the past 6 months, who have no history of autoimmune or immune deficiency diseases, epilepsy and malignant tumors, allergic diseases, granulomas associated with sarcoidosis and Osler's nodes in endocarditis, any active inflammation and infection, and no previous sensitivity to polydeoxyribonucleotides and lidocaine. No pregnant and breastfeeding.
Intervention groups
Injection of INOVOSENSE MESOCELL PLUS mesogel for improvement of face skin elasticity and rejuvenation. the products are in the 2 ml prefilled sterilized syringe containing: 40 mg polydeoxyribonucleotide 0.15% lidocaine hydrochloride
Main outcome variables
Skin elasticity level by cutometery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250308064973N1
Registration date: 2025-03-21, 1404/01/01
Registration timing: retrospective

Last update: 2025-03-21, 1404/01/01
Update count: 0
Registration date
2025-03-21, 1404/01/01
Registrant information
Name
mina masoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8243 0751
Email address
mina.masoudi@medisaara.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-10, 1403/12/20
Expected recruitment end date
2025-03-17, 1403/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of INOVOSENSE MESOCELL PLUS mesogel for improvement of face skin elasticity and rejuvenation
Public title
Evaluation of safety and efficacy of INOVOSENSE MESOCELL PLUS mesogel for improvement of face skin elasticity and rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
25 - 60 Years women and men Signs of skin aging, such as reduced skin elasticity and the presence of lines and wrinkles on the face
Exclusion criteria:
Any cosmetic facial procedures during the last 6 months Autoimmune or immune deficiency diseases Patients with epilepsy and malignant tumors History of allergic diseases Presence of granulomas associated with sarcoidosis and Osler's nodes in endocarditis Taking medications such as NSAIDs, platelet aggregation inhibitors, anticoagulants, and immunosuppressants Active inflammation or infection Allergy to polydeoxyribonucleotides or lidocaine Pregnancy and breastfeeding
Age
From 25 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
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 Tehran University of Medical Sciences
Street address
Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd.
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2025-03-04, 1403/12/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.671

Health conditions studied

1

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

Primary outcomes

1

Description
facial skin elasticity
Timepoint
Before the intervention and 4 weeks after the last injection
Method of measurement
cutometery

Secondary outcomes

1

Description
side effects
Timepoint
Before the intervention and 4 weeks after the last injection
Method of measurement
Based on patient's comments

2

Description
Signs of skin aging include lines and wrinkles
Timepoint
Before the intervention and 4 weeks after the last injection
Method of measurement
GAIS scale

Intervention groups

1

Description
Intervention group: INOVOSENSE MESOCELL PLUS mesogel injection for improvement of face skin elasticity and rejuvenation. the products are in the 2 ml prefilled sterilized syringe, which contains: Polydeoxyribonucleotide 40 mg, Lidocaine hydrochloride 0.25 % and Phosphate Buffer pH 7 q.s.: 2 ml
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology clinic of Razi Hospital
Full name of responsible person
Amirhooshang Ehsani
Street address
Razi Hospital- Vahdate-e-eslami St, Tehran, Iran
City
tehran
Province
Tehran
Postal code
6391111996
Phone
+98 21 5288 8282
Email
ehsanih@sina.tums.ac.ir

2

Recruitment center
Name of recruitment center
Center for Research and Training in Skin Diseases And Leprosy
Full name of responsible person
Alireza firooz
Street address
No. 415, corner of Naderi (former Soheil) Street, Shahid Taleghani Street, Tehran
City
tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2221
Email
dr.alireza.firooz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Medisa Ara Gostar Iranian company
Full name of responsible person
Masoud Saghafi
Street address
Number 21, Jooybar Alley, Shad St, Molla Sadra St, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1435791999
Phone
+98 21 8885 6574
Email
contact@kmtmed.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medisa Ara Gostar Iranian company
Proportion provided by this source
100
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
Maryam Nasimi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vahdat Eslami Square, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0223
Email
nsm.maryam@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhooshang Ehsani
Position
Dermatologist and professor of Tehran University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital, Vahdat Eslami Square, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0223
Email
ehsanih@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Medisa Ara Gostar Iranian company
Full name of responsible person
Mina Masoudi
Position
Medical Adviser
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Number 21, Jooybar Alley, Shad St, Molla Sadra St, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1435791999
Phone
+98 21 8862 2761
Email
mina.masoudi@medisaara.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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