Safety and effectiveness assessment of injectable suspension of Inshape x Radiance plus (Nano Darou Pajuhan Pardis)for the treatment of the back of hand wrinkles.”
Safety and effectiveness assessment of injectable suspension of Inshape x Radiance plus (Nano Darou Pajuhan Pardis)for the treatment of the back of hand wrinkles.”
Design
Phase 1-2 single group. before -after, clinical study
Settings and conduct
The study will be conducted in center for research and training in skin diseases and leprosy. The participants in this study will receive a ready-to-inject syringe of Inship X Radiance produced by Nano Darou Pajuhan Pardis subcutaneously in small bolus injections (0.2-0.5cc/bolus) on the back of both hands. Assessment will be performed before treatment and 6 months after the injection including improvement assessment using digital photography and measurement the skin thickness and density.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 30 years, Moderate to very severe degree of hand wrinkles based on MHGS criteria, Agree to use safe methods of contraception, Signing an informed consent form and agreed to follow up.
Exclusion criteria:History of type 1 allergic reactions or anaphylaxis reaction, Pregnant or lactating or planning to become pregnant in the near future while studying, Allergy or sensitivity to lidocaine, Any abnormality or history of surgery on the back of hand
Intervention groups
The participants in this study will receive a ready-to-inject syringe of Inship X Radiance produced by Nano Darou Pajuhan Pardis subcutaneously in small bolus injections (0.2-0.5cc/bolus) on the back of both hands.
Main outcome variables
Percentage of subjects with improvement in back of hand wrinkles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N31
Registration date:2024-08-14, 1403/05/24
Registration timing:registered_while_recruiting
Last update:2024-08-14, 1403/05/24
Update count:0
Registration date
2024-08-14, 1403/05/24
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2024-11-10, 1403/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and effectiveness assessment of injectable suspension of Inshape x Radiance plus (Nano Darou Pajuhan Pardis)for the treatment of the back of hand wrinkles.”
Public title
Safety and effectiveness assessment of injectable suspension of Inshape x Radiance plus for the treatment of the back of hand wrinkles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 30 years
Moderate to very severe degree of hand wrinkles based on MHGS criteria
Agree to use safe methods of contraception.
Signing an informed consent form and agreed to follow up.
Exclusion criteria:
History of type 1 allergic reactions or anaphylaxis reaction
Pregnant or lactating or planning to become pregnant in the near future while studying
Allergy or sensitivity to lidocaine
Use of antiplatelet drugs during 72 hours before treatment and anticoagulant drugs during 2 weeks before or during treatment.
Any abnormality or history of surgery on the back of hand
Age
From 30 years old
Gender
Both
Phase
1-2
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)
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 The Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
Unit 1-219, 2nd floor, The Institute of Pharmaceutical Sciences, Faculty of Pharmacy, 16 Azar Avenue
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2024-07-29, 1403/05/08
Ethics committee reference number
IR.TUMS.TIPS.REC.1403.072
Health conditions studied
1
Description of health condition studied
The back of hand wrinkles
ICD-10 code
R23.4
ICD-10 code description
Changes in skin texture
Primary outcomes
1
Description
Percentage of subjects with improvement in back of hand wrinkles
Timepoint
30 days after intervention
Method of measurement
Merz Hand Grading Scale (MHGS)
Secondary outcomes
1
Description
Thickness and density of dermis
Timepoint
Before intervention and 6 months later
Method of measurement
Skin ultrasound
2
Description
changes in the intensity of hand wrinkles
Timepoint
Before intervention and 6 months later
Method of measurement
Based on the GAIS (Global Aesthetic Improvement Scale)
Intervention groups
1
Description
Intervention group: The participants in this study will receive a ready-to-inject syringe of Inship X Radiance (Calcium Hydroxyl Apatite + Lidocaine) produced by Nano Darou Pajuhan Pardis subcutaneously in small bolus injections (0.2-0.5cc/bolus) on the back of both hands. Each ready to inject Radiance Plus syringe contains 0.8 cc of calcium hydroxyl apatite + lidocaine suspension.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Street address
No. 415, Naderi Aven., Taleghani St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nano Darou Pajouhan Pardis Company
Full name of responsible person
Navid Goodarzi
Street address
No. 18, Between Motahari Street and South Etaati St., Marzdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1464736143
Phone
+98 912 635 4536
Email
info@nanodaru.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?