Safety and efficacy of oral supplement sachet of "Collagen Gold" in improving biophysical parameters and skin ultrasound indexes
Design
Single group, phase 2, before -after clinical study. sample size is 19. The study is not randomized.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 19 healthy volunteers with skin wrinkle will be selected and enrolled in the study after signing consent form. Volunteers will be taught to use oral supplement sachet of "Collagen Gold" for 12 weeks once in a day. Before intervention , 6 and 12 weeks after using changing in skin will be measured. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages 40 to 65, Healthy people with skin type II to V, Signing the consent form for participation in the study
Exclusion criteria: History of using RF, anti aging and intense pulsed light during the past 6 months, Active smoker in last 2 years, Pregnancy or lactating
Intervention groups
Daily consumption of a supplement sachet with Collagen Gold brand for 12 weeks contains: 5000 mg of hydrolyzed collagen types 1 and 3, 50 mg hyaluronic acid, 80 mg of vitamin C.
Main outcome variables
Change in skin elasticity, Skin thickness and density and changes in stratum corneum hydration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N17
Registration date:2021-12-20, 1400/09/29
Registration timing:prospective
Last update:2021-12-20, 1400/09/29
Update count:0
Registration date
2021-12-20, 1400/09/29
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
2022-01-05, 1400/10/15
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of oral supplement sachet of "Collagen Gold" in improving biophysical parameters and skin ultrasound indexes
Public title
Safety and efficacy of oral supplement sachet of "Collagen Gold"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 40 to 65
Healthy people with skin type II to V
Signing the consent form for participation in the study
Exclusion criteria:
History of using RF, anti aging and intense pulsed light during the past 6 months
Active smoker in last 2 years
Pregnancy or lactating
Age
From 40 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
19
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
2021-11-28, 1400/09/07
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.973
Health conditions studied
1
Description of health condition studied
skin aging
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Skin elasticity
Timepoint
Before intervention , 6 and 12 weeks after using
Method of measurement
Cutometery
Secondary outcomes
1
Description
Skin thickness and density
Timepoint
Before intervention , 6 and 12 weeks after using
Method of measurement
Skin ultrasound
2
Description
changes in stratum corneum hydration
Timepoint
Before intervention , 6 and 12 weeks after using
Method of measurement
Corneometry
Intervention groups
1
Description
Intervention group: daily consumption of a supplement sachet with Collagen Gold brand for 12 weeks contains: 5000 mg of hydrolyzed collagen types 1 and 3, 50 mg hyaluronic acid, 80 mg of vitamin C.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy