Efficacy Evaluation of Products Against Long Wavelength Ultraviolet A1 and Visible Light Induced Biological Effects

NCT04181476 — Phase 2, Active not recruiting, 12 participants, Henry Ford Health System

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Registry	NCT04181476
Status	Active not recruiting
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	12 (Actual)
Sponsor	Henry Ford Health System (Other); collaborators: L'Oreal
Conditions	Sun Damaged Skin
Interventions	Sunscreening Agents (Drug)
Dates	start 2019-11-05, primary completion 2021-01-18, completion 2022-06-01 (estimated), first posted 2019-11-29, last updated 2022-01-28
Locations	1 site in United States

-Summary

The purpose of this study is to evaluate the efficacy of topical products in providing protection against the visible light and ultraviolet A1 (UVA1) part of sunlight. Ultraviolet radiation and visible light are both components of sunlight that reach the earth. It is important to test these topical products against visible light and UVA1 because our current sunscreens may not protect against these very well.

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+Arms and interventions

Arm	Type	Interventions	Description
Topical products and Untreated areas	Other	Drug: Sunscreening Agents	The subject will serve as their own control. Four different products will be tested.

Sunscreening Agents (Drug): Four different sunscreens

+Outcome measures

Primary outcomes

Change in Investigator's Global Assessment (IGA) [through study completion, an average of 1 week]: Assesses erythema and pigmentation
Change in Colorimetry [through study completion, an average of 1 week]: Measures erythema and pigmentation
Change in Diffuse Reflectance Spectroscopy [through study completion, an average of 1 week]: Measures erythema and pigmentation

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Patient age 18 and older
* Patients Fitzpatrick skin phototype (SPT) III-IV with normal skin health
* Patient able to understand requirements of the study and risks involved

Exclusion Criteria:

* A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
* A history of a relevant skin condition on any part of the patient's body (e.g. atopic dermatitis, eczema, vitiligo, sun burn, etc.
* A known history of photodermatoses
* A known history of photosensitivity disorders
* A known history of melanoma or non-melanoma skin cancers

+Locations (1)

Facility	City	Country	Status
Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,	Detroit, Michigan	United States

+Investigators

Iltefat Hamzavi, MD, Principal investigator, Henry Ford HS