Evaluation of 24 hours moisturizing effect of SynSkin cream
Design
It is a interventional study as a single group before-after clinical study.
Settings and conduct
The study will be conducted in Center for Research & Training in Skin Diseases and Leprosy. Participate will receive 25 μL of 24 hours moisturizer product(SynSkin) once a day for 2 weeks on assigned area on right forearm.The assessments of skin biophysical parameters (skin hydration, trans epidermal water loss, skin elasticity and skin friction) will be performed before intervention and 1, 4, 24 and 2 weeks later and changes will be compared before and after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: general health, signing inform consent, clinically diagnosed dry skin Exclusion criteria: active smoker, Presenting an infection or active skin lesion on treatment site, cutaneous or systemic diseases lead to dry skin, pregnancy or breast feeding
Intervention groups
Using moisturizer products (SynSkin ) once a day for 2 weeks.
Main outcome variables
Change of stratum corneum hydration 24 hours after application
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N21
Registration date:2022-05-09, 1401/02/19
Registration timing:retrospective
Last update:2022-05-09, 1401/02/19
Update count:0
Registration date
2022-05-09, 1401/02/19
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
2021-06-07, 1400/03/17
Expected recruitment end date
2021-07-29, 1400/05/07
Actual recruitment start date
2021-06-07, 1400/03/17
Actual recruitment end date
2021-06-28, 1400/04/07
Trial completion date
2021-07-27, 1400/05/05
Scientific title
Evaluation t of 24 -hour moisturizing effect of SynSkin hydrating cream in people with dry skin. A before and after clinical study
Public title
Evaluation the effect of a 24 -hour moisturizer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female aged 18-60 years
The presence of skin dryness
Voluntary participation and signing written informed consent
Exclusion criteria:
Active skin diseases
Active smoking
Pregnancy or breastfeeding
Using systemic corticosteroid in the past 30 days
Use of any topical drugs in the past 7 days
Scar, wound or any condition on the inner forearms that could interfere with a clear-cut assessment of the skin
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
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
2021-06-06, 1400/03/16
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.220
Health conditions studied
1
Description of health condition studied
Dry skin
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The change in stratum corneum hydration after using SynSkin cream
Timepoint
Before intervention and 1 and 4 hours, 24 h, 2weeks after using and one week after not using
Method of measurement
Corneometry
Secondary outcomes
1
Description
Trans Epidermal Water Loss
Timepoint
Before intervention and 1 and 4 hours, 24 h, 2weeks after using and one week after not using
Method of measurement
Tewameter
2
Description
Skin elasticity
Timepoint
Before intervention and 1 and 4 hours, 24 h, 2weeks after using and one week after not using
Method of measurement
Cutometery
Intervention groups
1
Description
Intervention group: : Topical use of 25 μL of SynSkin 24-hour herbal moisturizer once a day for 2 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy