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

NCT ID: NCT04181476

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-05

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sun Damaged Skin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Topical products and Untreated areas

The subject will serve as their own control. Four different products will be tested.

Group Type OTHER

Sunscreening Agents

Intervention Type DRUG

Four different sunscreens

Interventions

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Sunscreening Agents

Four different sunscreens

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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L'Oreal

INDUSTRY

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Iltefat Hamzavi

Senior Staff Physician, Director of Investigator-Initiated Trials

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iltefat Hamzavi, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford HS

Locations

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Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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13223

Identifier Type: -

Identifier Source: org_study_id

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