Water Immersion Studies of a Long-wear Sunscreen to Improve Protection Against Ultraviolet Radiation
Completed · Not applicable
Conditions studied: Sunburn
In brief
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)
Key facts
- Study ID
- NCT05767008
- Run by
- Nanometics (d.b.a. PHD Biosciences)
- People needed
- 25
- Starts
- 2021-09-01
- Expected to finish
- 2022-04-01
- Last updated by the study team
- 2023-03-13
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Nanometics — La Jolla, California, United States
Full record on ClinicalTrials.gov
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