Sunscreen Agents
Conditions
Keywords
Sun Protection Factor, Sunscreen
Brief summary
Evaluation of the effectiveness of sunscreen products by determining its Sun Protection Factor (SPF) against UV-B and UV-A
Detailed description
Sunscreen is intended to protect the skin from sun burn but since the amount of protection needed varies among individuals, sunscreen manufactures offer consumers difference levels of protection. These different levels of protection are expressed as a numerical value called the sun protection factor or SPF. The SPF is the ratio between the minimal erythema dose (MED) of sunscreen product of the protected skin and the MED of the unprotected skin. The minimal erythema dose in human skin is defined as the lowest ultraviolet B (UV-B) dose produces the first perceptible unambigous erythema with defined border appearing over most of the field of UVB exposure 16 - 24 hours after UVB exposure. The UVA protection factor is the ratio between the Minimal Persistent Pigmentation Darkening Dose (MPPDD) of sunscreen product of the protected skin and the MPPDD of the unprotected skin. The threshold response will be taken as an unequivocal pigment darkening with distinct border which persisted for at least 2 hours. The test products are Day Gel-0120-C and Day Gel-0120-D with active ingredients ethylhexyl methoxycinnamate, Diethylamino hydroxybenzoyl hexyl benzoate
Interventions
OTHERDay Gel-0120
Two milligrams of test article applied to the test area. The test products are Day Gel-0120C and Day Gel-0120-D. The products are applied together on the test area with
OTHERP5 Reference Standard (SPF 35 reference)
The reference product is P5 according to ISO 24444:2019. The application of reference product is similar with test product.
Sponsors
PT Paragon Technology and Innovation
Indonesia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female, 18-60 years of age 2. Fair skin with skin type II-IV of Fitzpatrick's skin type 3. Able to understand and comply to the investigators instruction. 4. Able to read, understand and sign up informed consent form.
Exclusion criteria
1. Subject with a history of abnormal response to sunlight or those taking medication which might produce an abnormal response to sunlight 2. Subject exhibiting current sun burn, sun tan, uneven skin tone, or visible skin disease which might be confused with a reaction from the test material or which might interfere with evaluation of test results 3. Individuals who are under doctor's care 4. Female subjects who indicate that they are pregnant or nursing 5. Individuals with known hypersensitivity to any sunscreen products 6. Individuals accustomed to using tanning beds
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure the SPF Value of the teat product | 2-24 hours post exposure | The mean of SPF value from all the subject |
Countries
Indonesia
Outcome results
None listed