Sun Protection Factor (SPF) / UVA Protection Factor Study

August 11, 2021 updated by: Prof. dr. Franciscus D. Suyatna, PhD, SpFK, Indonesia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Clinical Research Supporting Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPF evaluation
Healthy male or female subjects with Fitzpatrick Skin Type of II-IV were included in the SPF study
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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2-24 hours post exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

PT Paragon Technology and Innovation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2020

Primary Completion (Actual)

September 24, 2020

Study Completion (Actual)

September 24, 2020

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRSU.P.SPF_Paragon/02.20/07.03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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