Evaluation of the safety and effectiveness of Nutra moisturizing cream in improving chronic dry skin in sensitive skin
Design
The study is a phase 2-3 clinical trial, split body randomized and double-blind comparison with placebo.Randomization is done simply using blind card.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 20 healthy volunteers will be selected and enrolled in the study after signing consent form. Volunteers are taught to use of 25 μL of 2 types of Nutra moisturizing cream produced by Nova pharmed chemia and a placebo cream topically.Blinding the participants will be such that both products will be packed in the same containers, that are distinguished from each other only by code number and name of using area on the packaging. In order to blind the outcome assessor, the randomization list will be provided to a third person and the allocation of formulations to each of the participants' left or right organs will be done after receiving the random code. Before intervention, 4 hours after using and 4 weeks after not using changing in stratum corneum hydration will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People aged between 18 to 60 years, Bilateral and almost symmetric dryness in upper or lower extremities according to researcher physician, General health, Signing the informed consent form
Exclusion criteria:
active smoker, active skin lesion of treatment site, Cutaneous or systemic diseases or any skin condition caused dry skin such as diabetes and hypothyroidism, Currently pregnant or lactating
Intervention groups
Intervention group: Topical use of 25 μL of 2 types of Nutra moisturizing cream produced by Nova pharmed chemia.
Control group: Topical use of 25 μL of a placebo cream.
Main outcome variables
Changing in stratum corneum hydration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210130050179N7
Registration date:2023-04-26, 1402/02/06
Registration timing:registered_while_recruiting
Last update:2023-04-26, 1402/02/06
Update count:0
Registration date
2023-04-26, 1402/02/06
Registrant information
Name
Taraneh Yazdanparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
drtaraneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the safety and effectiveness of Nutra moisturizing cream in improving chronic dry skin in sensitive skin
Public title
Evaluation of the safety and effectiveness of Nutra moisturizing cream in improving dry skin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged between 18 to 60 years
Bilateral and almost symmetric dryness in upper or lower extremities according to researcher physician
General health
Signing the informed consent form
Exclusion criteria:
active smoker
active skin lesion of treatment site
Cutaneous or systemic diseases or any skin condition caused dry skin such as diabetes and hypothyroidism
Currently pregnant or lactating
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
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done simply using blind card. In this way, the name of the formulations is written on the same cards and for each of the left or right organs a card is selected randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding the participants will be such that both products will be packed in the same containers, that are distinguished from each other only by code number and name of using area on the packaging. In order to blind the outcome assessor, the randomization list will be provided to a third person and the allocation of formulations to each of the participants' left or right organs will be done after receiving the random code.
Placebo
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
2024-02-21, 1402/12/02
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.118
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 placebo
Timepoint
Before intervention, 4 hours after using and 4 weeks after not using.
Method of measurement
Corneometry
Secondary outcomes
1
Description
Trans Epidermal Water Loss
Timepoint
Before intervention and 1 and 4 hours, 1 and 2 weeks after using
Method of measurement
Tewameter
Intervention groups
1
Description
Intervention group: Topical use of 25 μL of 2 types of Nutra moisturizing cream produced by Nova pharmed chemia.
Category
Treatment - Drugs
2
Description
Control group: Topical use of 25 μL of a placebo cream.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy