Efficacy comparison of 2 tinted and invisible sunscreen products with similar formulation and SPF 50, on reducing skin damage caused by sunlight in the Iranian population with skin type 2 to 4:Single-blind randomized clinical trial
Comparing the effectiveness of tinted and invisible sunscreen products with similar formulations and SPF 50 on reduction of skin damage caused by sun irradiation in Iranian population with skin type 2 to 4
Design
It is a phase II interventional study as a randomized and one-way blind before-after clinical study.110 adult volunteers with atopic dermatitis will participate in the study after signing informed consent. Randomization is done simply using blind card so that the names of the creams are inserted on the same cards and for each participant a card is selected randomly. Skin factors including skin melanin and Changes in erythema intensity (factor E) and skin lightness (factor L) will measured before intervention and 8 and 16 weeks after treatment.
Settings and conduct
The study will be conducted in Center for Research & Training in Skin Diseases and Leprosy. Participants will receive tinted and invisible Prime sunscreen products with similar formulations and SPF 50Cream, third in a day for 8 weeks on whole of face. Due to the difference in appearance of two types of creams, the evaluating person who performs the biophysical tests of the skin and the physician supervising the tests is different from who assigned the creams and therefore the study is outcome assessor blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Healthy people 18 to 60 years old, Signing the consent form for participation in the study
Exclusion criteria:
History of any skin disease except acne, allergies and rosacea, Facial skin surgery in the last 2 months, Any systemic disease that affects the skin (diabetes, thyroid disease and etc..)
Intervention groups
Using of tinted and invisible sunscreen products with similar formulations and SPF 50 is used every three hours from 8 AM to 8 PM (4 times in a day)
Main outcome variables
Changes in skin melanin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210130050179N3
Registration date:2022-05-17, 1401/02/27
Registration timing:prospective
Last update:2022-05-17, 1401/02/27
Update count:0
Registration date
2022-05-17, 1401/02/27
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
2022-05-22, 1401/03/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy comparison of 2 tinted and invisible sunscreen products with similar formulation and SPF 50, on reducing skin damage caused by sunlight in the Iranian population with skin type 2 to 4:Single-blind randomized clinical trial
Public title
Efficacy comparison of 2 tinted and invisible sunscreen products with similar formulation and SPF 50, on reducing skin damage caused by sunlight
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy people aged between 18 to 60 years
Signing the informed consent form
Exclusion criteria:
History of any skin disease except acne, allergies and rosacea
Facial skin surgery in the last 2 months
Any systemic disease that affects the skin (diabetes, thyroid disease and etc..)
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method will be used to assign samples to each of the tinted and invisible sunscreen groups. At first, the size of the blocks will be considered to be 10, according to the number of samples, 11 blocks will be selected based on a table of random numbers and individuals will be assigned to groups based on their position in the blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the difference in appearance of two types of creams, the assessor person who performs the biophysical tests of the skin and the physician supervising the tests are different from who assigned the creams and therefore the study is outcome assessor blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research of medical school-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
2021-06-16, 1400/03/26
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.287
Health conditions studied
1
Description of health condition studied
Reduce skin damage caused by sunlight
ICD-10 code
L55
ICD-10 code description
Sunburn
Primary outcomes
1
Description
Skin melanin
Timepoint
Before intervention and 8 and 16 weeks after treatment
Method of measurement
mexameter
Secondary outcomes
1
Description
Changes in erythema intensity (factor E) and skin lightness (factor L)
Timepoint
Before intervention and 8 and 16 weeks after treatment
Method of measurement
Using Visioface device and CSI software
Intervention groups
1
Description
Intervention group: Tinted sunscreen cream will be used every three hours from 8 AM to 8 PM (4 times in a day)
Category
Treatment - Drugs
2
Description
Control group: Invisible sunscreen cream will be used every three hours from 8 AM to 8 PM (4 times in a day)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy