Sun Protection Factor (SPF) - Static and Water Resistant Assay

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02857738

Enrollment

Registered

2016-08-05

Start date

2015-05-26

Completion date

2015-06-10

Last updated

2018-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sunscreen Agents

Brief summary

Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.

Interventions

DRUGBAY 987519

Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.

DRUGSPF 15 Control

Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Male or female of an age of 18 to 70 years inclusive; * Fitzpatrick Skin Type I, II and/or III for SPF testing; * Good health as determined from the CRO Subject History Form (SHF); * Signed and dated Informed Consent Form; * Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form; * An unambiguous minimal erythema dose (MED).

Design outcomes

Primary

Measure	Time frame
Evaluation of water resistant SPF in accordance to ISO 24444	16-24 hrs post exposure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026