Sun Protection Factor (SPF) / UVA Protection Factor Study

Not Applicable

Completed

• Conditions: Sunscreen Agents
• Interventions: Other: Day Gel-0120; Other: P5 Reference Standard (SPF 35 reference)

• Registration Number: NCT05004168
• Lead Sponsor: Indonesia University

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

Study Timeline

• Study Start: 2020-09-02
• Primary Completion: 2020-09-24
• Study Completion: 2020-09-24
• Study First Submitted: 2021-07-08
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-13
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Research Supporting Unit; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia