Clinical trial NCT05004168: Sun Protection Factor (SPF) / UVA Protection Factor Study
Official title: The Efficacy of Sun Protection Factor (SPF) Against UV-B and UV-A of Cosmetic Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreen Agents
Keywords: Sun Protection Factor
Sunscreen
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: PT Paragon Technology and Innovation
First posted: 2021-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: To measure the SPF Value of the teat product
timeFrame: 2-24 hours post exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Clinical Research Supporting Unit
state: DKI Jakarta
Study officials:
affiliation: Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia
name: Frans Suyatna, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heckman CJ, Chandler R, Kloss JD, Benson A, Rooney D, Munshi T, Darlow SD, Perlis C, Manne SL, Oslin DW. Minimal Erythema Dose (MED) testing. J Vis Exp. 2013 May 28;(75):e50175. doi: 10.3791/50175.
citation: Donglikar MM, Deore SL. Sunscreens: A review. Pharmacognosy Journals. 2016;8(3):171-179