NCT05767008

Brief Summary

This study is designed to determine the Sun Protection Factor (SPF) of a test product following 80 Minute Water Immersion methodology defined in Final Monograph - Code of Federal Regulations Title 21 - "Labeling and Effectiveness Testing; Sunscreen Drug Products; Required Labeling Based on Effectiveness Testing", Final Rule, 21 CFR 201.327.(j)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

March 1, 2023

Last Update Submit

March 11, 2023

Conditions

Sunburn

Outcome Measures

Primary Outcomes (1)

  • SPF determination

    SPF determination before and after water immersion

    80 minutes

Study Arms (1)

Static and water immersion SPF evaluation

EXPERIMENTAL
Other: Sunscreen -R43

Interventions

Sunscreen -R43OTHER

Long wear metal oxide particles

Static and water immersion SPF evaluation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males (n=12) and females (n=13) 18 through 55 years.
  • Fitzpatrick skin type I, II or III.
  • Free from dermatological disorders.

You may not qualify if:

  • Volunteers younger than 18 years, or older than 55 years.
  • Volunteers of Fitzpatrick skin type IV or greater.
  • Volunteers with dermatological disorders or the presence of non-uniform pigmentation, skin tone and texture, warts, moles, nevi, scars, blemishes and active dermal lesions at the desired test sites.
  • Volunteers being treated with photosensitizing agents, or have been treated with photosensitizing agents in the prior 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanometics

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Sunburn

Condition Hierarchy (Ancestors)

Photosensitivity DisordersSkin DiseasesSkin and Connective Tissue DiseasesBurnsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 13, 2023

Study Start

September 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

March 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)