Skip to main content
OpenTrials
Completed

NCT Number: NCT05004168

Sun Protection Factor (SPF) / UVA Protection Factor Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sunscreen Agents

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Supporting Unit

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female, 18-60 years of age
  • Fair skin with skin type II-IV of Fitzpatrick's skin type
  • Able to understand and comply to the investigators instruction.
  • Able to read, understand and sign up informed consent form.

Exclusion criteria

  • Subject with a history of abnormal response to sunlight or those taking medication which might produce an abnormal response to sunlight
  • 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
  • Individuals who are under doctor's care
  • Female subjects who indicate that they are pregnant or nursing
  • Individuals with known hypersensitivity to any sunscreen products
  • Individuals accustomed to using tanning beds

Treatment and study plan

Day Gel-0120

Other

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)

Other

The reference product is P5 according to ISO 24444:2019. The application of reference product is similar with test product.

Primary outcomes

  1. To measure the SPF Value of the teat product

    Time frame: 2-24 hours post exposure

    The mean of SPF value from all the subject

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • PT Paragon Technology and Innovation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2021
Registry last updated
Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.