Comparison of the effect of wheat callus extract in nanoliposomal form with nanoliposomes without drug (as a control) in reducing skin wrinkles and skin rejuvenation in female volunteers
Design
The clinical trial has the same control and intervention group, meaning that all people will receive both control and intervention equally, with the difference that they will receive the drug-containing formulation on the right and the drug-free formulation on the left side of the face under equal conditions. This tial is non-blinded and not randomised , phase 2, 3 and parallel study will be performed on 24 women.
Settings and conduct
The medicine is prepared monthly in the laboratory and the volunteers will take the medicine and the placebo which is in the form of gel at home, once daily, topically around the eyes and photographing the wrinkles around the eyes of the volunteers in the beauty clinic under the supervision of a dermatologist. Depth of the wrinkles will be compared before and after taking the medicine and placebo. This study, is not blinded and all volunteers will receive both medication and placebo under the same conditions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with wrinkles in parts of the face (around the eyes), age group 30 to 55 years
Exclusion criteria: History of previous allergies to cosmetics, concomitant use of anti-wrinkle products in the study areas, pregnancy and lactation, history of cardiovascular disease and diabetes, and hypothyroidism or hyperthyroidism.
Intervention groups
All volunteers will use the drug around the right eye and the placebo as a control around the left eye, and the effects of the drug and placebo will be compared.
Main outcome variables
Skin wrinkles and rejuvenate the skin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211206053302N1
Registration date:2022-01-17, 1400/10/27
Registration timing:prospective
Last update:2022-01-17, 1400/10/27
Update count:0
Registration date
2022-01-17, 1400/10/27
Registrant information
Name
Ehsan Adhami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3365 7497
Email address
adhamiehsan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-30, 1400/11/10
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of wheat callus extract in rejuvenation and reduction of skin wrinkles with clinical evaluation in volunteers
Public title
Evaluation of the effect of wheat on skin rejuvenation in women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with facial wrinkles in the desired areas
age of 30 to 55 years
Exclusion criteria:
History of previous allergies to cosmetics
Estrogen therapy
Simultaneous use of anti-wrinkle products in the desired area
Pregnancy and lactation
History of cardiovascular disease, diabetes, hypothyroidism or hyperthyroidism
Age
From 30 years old to 55 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
More than 1 sample in each individual
Number of samples in each individual:
24
Each volunteer will receive both medication (on one side of the face) and placebo (on the other side of the face).
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, all 24 volunteers will use the drug on the right side of the face around the right eye and the placebo on the other side of the face symmetrically, and the effect of the drug and the placebo on reducing wrinkles around the eyes will be compared.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite of Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Approval date
2021-11-15, 1400/08/24
Ethics committee reference number
IR.TBZMED.REC.1400.740
Health conditions studied
1
Description of health condition studied
Wrinkles - Skin aging
ICD-10 code
R23.8
ICD-10 code description
Other skin changes
Primary outcomes
1
Description
Comparison of the effect of wheat extract on skin rejuvenation and reduction of depth, size and number of facial wrinkles
Timepoint
At the beginning of the study and 3 and 6 months after the start of the trial
Method of measurement
Facial photos and scoring by a dermatologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Evaluation of the effect of wheat callus extract containing polyphenols, phenolic acid, flavonoids, triterpenes, carotenoids and peptides, in the form of nanoliposomal gel formulation with a concentration of 0.2% for daily topical use (50 mg of Pure active ingredient) once daily for 6 months on the right side of the face (around the right eye) on 24 female volunteers. All stages of preparation of this drug (including culture and preparation of callus and extraction and preparation of nanoliposome formulation and gel form) will be performed by the researcher and no company or organization will have a role in its preparation.
Category
Treatment - Other
2
Description
Control group: Evaluation of the effect of drug-free nanoliposomes in gel formulation, once daily topically as a placebo for 6 months on the left side of the face (around the left eye) on 24 female volunteers. All stages of preparation of this drug (including culture and preparation of callus and extraction and preparation of nanoliposome formulation and gel form) will be performed by the researcher and no company or organization will have a role in its preparation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Technology Center of Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hamed Hamishehkar
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 914 316 9252
Email
hamishehkar.hamed@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hamed Hamishehkar
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3335 5389
Email
hamishehkar.hamed@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ehsan Adhami
Position
pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3335 5389
Email
adhamiehsan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hamed Hamishekar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3335 5389
Email
hamishehkar.hamed@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ehsan Adhami
Position
pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3335 5389
Email
adhamiehsan@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document