Evaluation of safety and efficacy of Ahmadi anti-aging cream in skin rejuvenation and improving skin wrinkle
Design
Single group, phase 2, before -after clinical study. sample size is 20.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 20 healthy volunteers will be selected and enrolled in the study after signing consent form. Volunteers are taught to use the study product for 8 weeks twice a day on their faces. Before intervention and at the end of 4 and 8 weeks later changing in facial skin wrinkles will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
In terms of wrinkles, the skin should be grade 2 or 3 according to the Glogau scale.
Signing the consent form for participation in the study.
exclusion criteria:
Volunteers should not use any cream other than sunscreen and moisturizer,during the study.
History of any type of cosmetic surgery over the past 3 years at the treatment site.
History of using RF within the past year.
History of botulinum toxin injection, laser or intense pulsed light within the past 6 months.
Any immunodeficiency or use of immunosuppressive drugs (cancer, chronic liver and kidney disease, etc.).
Pregnancy or lactating.
Active smoker in last 2 years.
Intervention groups
Topical use of rejuvenating cream of Javansaz Ahmadi Company for 8 weeks twice a day on the full face.
Main outcome variables
Changing in facial skin wrinkle using global aesthetic improvement scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N6
Registration date:2020-05-14, 1399/02/25
Registration timing:retrospective
Last update:2020-05-14, 1399/02/25
Update count:0
Registration date
2020-05-14, 1399/02/25
Registrant information
Name
Aniseh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
a_samadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
2020-01-12, 1398/10/22
Actual recruitment end date
2020-04-19, 1399/01/31
Trial completion date
2020-04-19, 1399/01/31
Scientific title
Evaluation of safety and efficacy of Ahmadi anti-aging cream in skin rejuvenation and improving skin wrinkle
Public title
To evaluate the safety and efficacy of Ahmadi anti-aging cream in skin rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
In terms of wrinkles, the skin should be grade 2 or 3 according to the Glogau scale.
Signing the consent form for participation in the study
Exclusion criteria:
Volunteers should not use any cream other than sunscreen and moisturizer,during the study.
History of any type of cosmetic surgery over the past 3 years at the treatment site
History of using RF within the past year
History of botulinum toxin injection, laser or intense pulsed light within the past 6 months
Any immunodeficiency or use of immunosuppressive drugs (cancer, chronic liver and kidney disease, etc.)
Pregnancy or lactating
Active smoker in last 2 years
Age
From 30 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
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
2019-12-17, 1398/09/26
Ethics committee reference number
IR.TUMS.VCR.REC.1398.711
Health conditions studied
1
Description of health condition studied
skin aging
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changing in facial skin wrinkle using global aesthetic improvement scale
Timepoint
before intervention , 4 and 8 weeks later
Method of measurement
One independent dermatologist will perform clinical assessments in a blinded fashion by scoring every photograph according to the global aesthetic improvement scale .
Secondary outcomes
1
Description
Skin elasticity
Timepoint
before intervention and 4 and 8 weeks later
Method of measurement
Cutometery
2
Description
Area and volume of nasolabial fold
Timepoint
before intervention and 4 and 8 weeks later
Method of measurement
VisioFace
Intervention groups
1
Description
Intervention group: Topical use of Ahmadi rejuvenating cream manufactured by Ahmadi Company for 8 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
center for research and training in skin diseases and leprosy