Evaluation the effect of 3 compound formulation of moisturizers compare with similar commercial products
Design
It is a interventional study as a randomized double blinded, intra subject clinical study. 30 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 each moisturizer product , twice 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 and skin elasticity) will be performed before intervention and 1, 4, 24 and 2 weeks later as well as one week after stop taking it . 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
Intervention group: Using 3 formulated moisturizers twice a day for 2 weeks
Control group: Using 3 commercial formulated moisturizers twice a day for 2 weeks
Main outcome variables
Comparison the change in stratum corneum hydration after using 3 types of moisturizers and similar commercial formulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N9
Registration date:2020-05-31, 1399/03/11
Registration timing:registered_while_recruiting
Last update:2020-05-31, 1399/03/11
Update count:0
Registration date
2020-05-31, 1399/03/11
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
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of 3 compound formulation of moisturizers compare with similar commercial products
Public title
Evaluation the effect of 3 compound formulation of moisturizers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female aged 18-60 years
The presence of skin dryness base on Corneometery
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
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
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
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
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.1398.710
Health conditions studied
1
Description of health condition studied
Skin moisturizing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comparison the change in stratum corneum hydration after using 3 types of moisturizers and similar commercial 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
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: Using 3 formulated moisturizers twice a day for 2 weeks
Category
Treatment - Drugs
2
Description
Control group: Using 3 commercial formulated moisturizers twice a day for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
center for research and training in skin diseases and leprosy