Clinical evaluation of the safety and effectiveness of the nanofiber undereye pad containing ketone enzyme to improve surface wrinkles and dark circles under the eyes compared to placebo
Clinical evaluation of the safety and effectiveness of the nanofiber undereye pad containing ketone enzyme to improve surface wrinkles and dark circles under the eyes compared to placebo
Design
It is a phase II interventional study as a randomized clinical study.10 healthy adult volunteers will participate enrolled in the study after signing informed consent.
Settings and conduct
The study will be conducted in Center for Research & Training in Skin Diseases and Leprosy. Participants will receive the nanofiber undereye pad containing ketone enzyme , 30 minutes in a day for 6 days under-eye area. The assessments of dark circle and wrinkle of under eye area as well as skin biophysical parameters (melanin and skin elasticity) will be performed before intervention, 6 and 28 days after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male or female aged 18-59 years, Signed informed consent knowingly, The presence of mild to moderate periorbital wrinkle and darkness
Exclusion criteria: Using any eye product within 2 weeks before the intervention, Strict diet in the period of 2 weeks before the intervention, Pregnancy or lactation, Being exposed to strong sunlight during the day
Intervention groups
Intervention group: 30 minutes of using nanofiber under-eye pads containing ketone co-enzyme made by Nanotarpak company for 6 days
Control group: 30 minutes of using a nanofiber under-eye pad without active ingredients for 6 days
Main outcome variables
Assessment of under eye dark circle and wrinkle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210130050179N9
Registration date:2024-02-25, 1402/12/06
Registration timing:registered_while_recruiting
Last update:2024-02-25, 1402/12/06
Update count:0
Registration date
2024-02-25, 1402/12/06
Registrant information
Name
Taraneh Yazdanparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
drtaraneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the safety and effectiveness of the nanofiber undereye pad containing ketone enzyme to improve surface wrinkles and dark circles under the eyes compared to placebo
Public title
Clinical evaluation of the safety and effectiveness of the nanofiber undereye pad to improve surface wrinkles and dark circles under the eyes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female aged 18-59 years
Signed informed consent knowingly
The presence of mild to moderate periorbital wrinkle and darkness
Exclusion criteria:
Using any eye product within 2 weeks before the intervention
Strict diet in the period of 2 weeks before the intervention
Pregnancy or lactation
Being exposed to strong sunlight during the day
Age
From 18 years old to 59 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
After the measurements, the lower area of the right or left eye was used for the use of nanofiber under eye pad containing the active substance ( ketone) and the opposite area as a control for using nanofiber under eye pad without the active substance. Randomization is done simply using blind card. In this way, the name of the formulations is written on the same cards and for each of the left or right area, a card is selected randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
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
2024-01-21, 1402/11/01
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.157
Health conditions studied
1
Description of health condition studied
periorbital wrinkle, dark circle and puffiness
ICD-10 code
R23.4
ICD-10 code description
Changes in skin texture
Primary outcomes
1
Description
Assessment of under eye dark circle and wrinkle
Timepoint
Before intervention and 6 and 28 days after treatment
Method of measurement
Based on GIAS(Global Aesthetic Improvement Scale)
Secondary outcomes
1
Description
Melanin content
Timepoint
fore intervention and 6 and 28 days after treatment
Method of measurement
Mexameter
2
Description
Infra-orbital pigmentation severity and degree of lightness
Timepoint
fore intervention and 6 and 28 days after treatment
Method of measurement
Visioface
Intervention groups
1
Description
Intervention group: 30 minutes of using nanofiber under-eye pads containing ketone co-enzyme made by Nanotarpak company for 6 days
Category
Treatment - Devices
2
Description
Control group: 30 minutes of using a nanofiber under-eye pad without active ingredients for 6 days
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy