Protocol summary

Study aim
Safety and efficacy assessment of Synskin triple action eye contour cream (invisible) for reducing periorbital wrinkle, dark circle and puffiness
Design
It is a phase II interventional study as a non-randomized and before-after clinical study.20 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 eye contour cream, twice a day for 8 weeks on periorbital area. The assessments of area, volume and depth of periorbital wrinkles as well as skin biophysical parameters (skin hydration, trans epidermal water loss, erythema, melanin and skin elasticity) will be performed before intervention, 4 and 8 weeks after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male or female aged 30-60 years,The presence of periorbital wrinkle, dark circle and puffiness, No change in life style during the study, Signed informed consent knowingly Exclusion criteria: Critical untreated systemic disease in medical history, Any facial rejuvenation treatment, including treatment with topical or oral products or supplements during the last four weeks, Any facial rejuvenation treatment including rejuvenation devices or surgical procedures and Botox injections during the last four months, Sensitivity and allergy to the components of the formulation, Use of any eye cream or eye sunscreen cream during the last four weeks, Use of anti-wrinkle or brightening cleansers over the past four weeks, Pregnancy or lactation
Intervention groups
Using Synskin triple action eye contour cream twice a day for 8 weeks
Main outcome variables
Assessment of periorbital wrinkle, dark circle and puffiness by three independent physician using 0-3 scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210130050179N1
Registration date: 2021-02-20, 1399/12/02
Registration timing: registered_while_recruiting

Last update: 2021-02-20, 1399/12/02
Update count: 0
Registration date
2021-02-20, 1399/12/02
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
2021-02-14, 1399/11/26
Expected recruitment end date
2021-06-16, 1400/03/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy assessment of Synskin triple action eye contour cream (invisible) for reducing periorbital wrinkle, dark circle and puffiness
Public title
Safety and efficacy assessment of Synskin triple action eye contour cream
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female aged 30-60 years The presence of periorbital wrinkle, dark circle and puffiness No change in life style during the study Signed informed consent knowingly
Exclusion criteria:
Critical untreated systemic disease in medical history Any facial rejuvenation treatment, including treatment with topical or oral products or supplements during the last four weeks Any facial rejuvenation treatment including rejuvenation devices or surgical procedures and Botox injections during the last four months Sensitivity and allergy to the components of the formulation Use of any eye cream or eye sunscreen cream during the last four weeks Use of anti-wrinkle or brightening cleansers over the past four weeks Pregnancy or lactation
Age
From 30 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
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-02-04, 1399/11/16
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1052

Health conditions studied

1

Description of health condition studied
periorbital wrinkle, dark circle and puffiness
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Assessment of periorbital wrinkle, dark circle and puffiness by three independent physician using 0-3 scale
Timepoint
Before intervention and 4 and 8 weeks after treatment
Method of measurement
Three independent dermatologists perform evaluation and scoring with the help of right and left lateral view and full face photos based on the percentage of improvement in periorbital wrinkles, dark circle and puffiness using scale 0 to 3 (0 = no improvement 1 = relative improvement 2 = good improvement 3 = Excellent improvement) .

Secondary outcomes

1

Description
Area, volume and depth of periorbital wrinkle
Timepoint
Before intervention and 4 and 8 weeks after treatment
Method of measurement
Visioface

2

Description
periorbital dark circle grading using Characteristics of Dark circles grade
Timepoint
Before intervention and 4 and 8 weeks after treatment
Method of measurement
Research physician will perform clinical assessments according to the Characteristics of Dark circles grade

3

Description
Melanin content
Timepoint
Before intervention and 4 and 8 weeks after treatment
Method of measurement
Mexameter

4

Description
stratum corneum hydration
Timepoint
Before intervention and 4 and 8 weeks after treatment
Method of measurement
Corneometer

5

Description
Trans epidermal water loss
Timepoint
Before intervention and 4 and 8 weeks after treatment
Method of measurement
Tewameter

6

Description
Erythema
Timepoint
Before intervention and 4 and 8 weeks after treatment
Method of measurement
Mexameter

7

Description
Fitzpatrick’s Classification of Facial Wrinkling & degree of Elastosis
Timepoint
Before intervention and 4 and 8 weeks after treatment
Method of measurement
Research physician will perform clinical assessments according to the Fitzpatrick’s Classification

8

Description
Infra-orbital pigmentation severity and degree of lightness
Timepoint
Before intervention and 4 and 8 weeks after treatment
Method of measurement
Visioface

Intervention groups

1

Description
Intervention group: Using Synskin triple action eye contour cream twice a day for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy
Full name of responsible person
Taraneh Yazdanparast
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Email
drtaraneh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran Avandfar Company
Full name of responsible person
Nader Soltani Hoseini
Street address
No.80,Baqerkhan Ave. ,Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1441764181
Phone
+98 21 6690 5990
Email
info@iranbath.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Avandfar 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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Taraneh yazdanparast
Position
Research Physician
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Email
drtaraneh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Professor of dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 7921
Email
firozali@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Clinical Research
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Email
ahmadi.maryam648@gmail.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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