Evaluation of the effect of 2 super moisturizer formulations on the skin barrier function
Design
It is a interventional study as a randomized double blinded, intra subject clinical study. 20 healthy adult volunteers will participate enrolled in the study after signing infirmed consent. Simple randomization is performed to assign each treatment site in subjects, using blind cards.
Settings and conduct
the study will be conducted in Center for Research & Training in Skin Diseases and Leprosy. Participate will receive 25 μL of 2 types of super moisturizer products (Eucerin and Prime) as well as cream base formulation , once a day for 2 weeks on assigned area on right and left forearms.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. After 2 weeks skin biopsy will be performed from test and control site and Aquaporin 3 expression will be assessed using real time PCR. participant blindness performed packing products in similar containers with different numeric code .For assessor blinding , the randomization list is given to a third person. Formulation to the participants assigned after receiving the randomization code by researcher.
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 2types of super moisturizer products (Eucerin Moist 24 and Prime Moist 24)as well as cream base formulation once a day for 2 weeks.
Main outcome variables
Change of stratum corneum hydration 24 hours after using 3 formulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N4
Registration date:2019-09-06, 1398/06/15
Registration timing:prospective
Last update:2019-09-06, 1398/06/15
Update count:0
Registration date
2019-09-06, 1398/06/15
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
2019-09-23, 1398/07/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of 24 -hour moisturizers on barrier function in healthy volunteers.
Public title
Evaluation the effect of 24 -hour moisturizers
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
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
3
Two determined regions from right and left forearm area are assigned to use one 24 hours formulation A and 24 hours formulation B randomly .The lower right forearm region is constantly considered as a control point and using cream base formulation.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by simple randomization using a blind card.In this way, the name of the formulation is written on the same card. A card is selected randomly for each region.
Blinding (investigator's opinion)
Double blinded
Blinding description
For participant blindness, products of all groups are packed in similar boxes with different numeric code. In case of assessor blinding, the randomization list is given to a third person. Assignment of the formulation to the treatment sites of participants is made after receiving the code of randomization by researcher.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National institue for medical research developement
Street address
No.21-Besat Street- West Fatemi Avenue
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.NIMAD.REC.1397.405
Health conditions studied
1
Description of health condition studied
Dry skin
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comparison the change in stratum corneum hydration after using two types of moisturizers and cream base formulation
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
aquaporin 3 (AQP3) mRNA level
Timepoint
After two weeks application
Method of measurement
Real time PCR
2
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
3
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: Tpical use of 25 μL of 2 types of super moisturizers: Prime 24 hours moisturizer (containing Imperata Cylindrica as active ingredient) and Euccerin Aquaporin active moisturizer (containing Gluco Glycerol as active ingredient ) once a day for 2 weeks
Category
Treatment - Other
2
Description
Control group: Using 25 μL of cream base formulation 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