Sun Protection Factor (SPF) / UVA Protection Factor Study | NCT05004168

Studies
Sun Protection Factor (SPF) / UVA Protection Factor Study

NCT05004168

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Aug 13, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Sunscreen Agents

Interventions

Day Gel-0120
P5 Reference Standard (SPF 35 reference)

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2020Actual

Primary Completion Date

Sep 24, 2020Actual

Completion Date

Sep 24, 2020Actual

First Submitted Date

Jul 8, 2021

First Submission Date that Met QC Criteria

Aug 11, 2021

First Posted Date

Aug 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2021

Last Update Posted Date

Aug 13, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. dr. Franciscus D. Suyatna, PhD, SpFK, Clinical Pharmacology Professor, Indonesia UniversityPrincipal Investigator

Lead Sponsor

Indonesia UniversityOTHER

Collaborators

Name	Class
PT Paragon Technology and Innovation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SPF evaluation	Experimental	Healthy male or female subjects with Fitzpatrick Skin Type of II-IV were included in the SPF study	Other: Day Gel-0120 Other: P5 Reference Standard (SPF 35 reference)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To measure the SPF Value of the teat product	The mean of SPF value from all the subject	2-24 hours post exposure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frans Suyatna, Prof, PhD	Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Supporting Unit		Jakarta Pusat	DKI Jakarta	10430	Indonesia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23748556	Background	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.
	Background	Donglikar MM, Deore SL. Sunscreens: A review. Pharmacognosy Journals. 2016;8(3):171-179