Evaluating effectiveness of the moisturizing cream produced by Behpad Teb Company using skin biometric methods.
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, 20 Cases of Clinically diagnosed dry skin will be selected and enrolled in the study after signing consent form. Volunteers will be taught to use moisturizing cream produced by Behpad Teb Company for 2 weeks, twice in a day. Before intervention ,1 hours and 2 weeks after using changing in stratum corneum hydration, skin elasticity and Trance Epidermal Water Loss (TEWL) will be measured. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Clinically diagnosed dry skin, general health, be willing to comply with all sessions of the treatment schedule and procedures.
exclusion criteria: active smokers, presenting an infection or active skin lesion of treatment site, cutaneous or systemic diseases or any skin condition caused dry skin, currently pregnant or lactating.
Intervention groups
Topical use of 25 μL of moisturizing cream produced by Behpad Teb Company on assigned area of the right forearm for 2 weeks twice a day.
Main outcome variables
Comparison changes in stratum corneum hydration.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N28
Registration date:2023-01-17, 1401/10/27
Registration timing:prospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
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
2023-02-20, 1401/12/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating effectiveness of the moisturizing cream produced by Behpad Teb Company using skin biometric methods.
Public title
Evaluating effectiveness of the moisturizing cream produced by Behpad Teb Company
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinically diagnosed dry skin
General health
Be willing to comply with all sessions of the treatment schedule and procedures.
Exclusion criteria:
active smokers
Presenting an infection or active skin lesion of treatment site
Cutaneous or systemic diseases or any skin condition caused dry skin.
Currently pregnant or lactating
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
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 The Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
Unit 1-219, 2nd floor,The Institute of Pharmaceutical Sciences, Faculty of Pharmacy,16 Azar Avenue
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-01-03, 1401/10/13
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.096
Health conditions studied
1
Description of health condition studied
Skin dryness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comparison changes in stratum corneum hydration.
Timepoint
Before intervention, 1 hours and 2weeks after using.
Method of measurement
Corneometry
Secondary outcomes
1
Description
Skin elasticity
Timepoint
Before intervention, 1 hours and 2weeks after using.
Method of measurement
Cutometery
2
Description
Trance Epidermal Water Loss
Timepoint
Before intervention, 1 hours and 2weeks after using.
Method of measurement
Tewameter
Intervention groups
1
Description
Intervention group: Topical use of 25 μL of moisturizing cream produced by Behpad Teb Company on assigned area of the right forearm for 2 weeks twice a day.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
center for research and training in skin diseases and leprosy