CompletedNot Applicable

Water Immersion Studies of a Long-wear Sunscreen to Improve Protection Against Ultraviolet Radiation

United States25 participantsStarted 2021-09-01

Plain-language 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)

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. 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

What they're measuring

SPF determination

Timeframe: 80 minutes

Trial details

NCT IDNCT05767008

SponsorNanometics (d.b.a. PHD Biosciences)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-01

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