Sun Protection Factor (SPF) / UVA Protection Factor Study

Sunscreen Agents Clinical Trial

Official title:

The Efficacy of Sun Protection Factor (SPF) Against UV-B and UV-A of Cosmetic Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05004168
• Other study ID #: CRSU.P.SPF_Paragon/02.20/07.03
• Status: Completed
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: September 24, 2020

Study information

• Verified date: August 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 24, 2020
• Est. primary completion date: September 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sunscreen Agents

Intervention

Other:
• Day 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
• P5 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.

Locations

Country	Name	City	State
Indonesia	Clinical Research Supporting Unit	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	PT Paragon Technology and Innovation

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

Donglikar MM, Deore SL. Sunscreens: A review. Pharmacognosy Journals. 2016;8(3):171-179

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the SPF Value of the teat product	The mean of SPF value from all the subject	2-24 hours post exposure

External Links

•   ISO 24444:2019-Sun Protection test methods-in vivo determination of the Sun Protection Factor (SPF)
•   Sun protection test methods-In vivo determination of sunscreen UVA protection