Sun Protection Factor (SPF) / UVA Protection Factor Study

University of Indonesia (UI)

Status: Completed

Conditions: Sunscreen Agents

Treatments: Other: Day Gel-0120; Other: P5 Reference Standard (SPF 35 reference)

Study type: Interventional

Funder types: Other

Identifiers

NCT05004168

CRSU.P.SPF_Paragon/02.20/07.03

Details and patient eligibility

About

Evaluation of the effectiveness of sunscreen products by determining its Sun Protection Factor (SPF) against UV-B and UV-A

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

SPF evaluation

Experimental group

Description:

Healthy male or female subjects with Fitzpatrick Skin Type of II-IV were included in the SPF study

Treatment:

Other: Day Gel-0120

Other: P5 Reference Standard (SPF 35 reference)