Optimizing Phototesting and Investigating Photobiology of Visible Light

NCT ID: NCT05964907

Last Updated: 2025-05-02

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

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2026-12-30

Brief Summary

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Specific Aim 1: To determine the impact of spectral composition of the VL+UVA1 source on the associated biologic effects.

Specific Aim 2: To investigate differential responses of subjects with different skin phototypes to VL+UVA1, including immediate and delayed erythema and pigmentation, and photodamage.

Detailed Description

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The design of the study consists of a total of 4 visits within a two week period. The first visit consists of VL+UVA1 irradiation with different light source on the opposite site of patients' back. A combination of non-invasive measurements (e.g., photography, redness and color changes of the skin using colorimetry and diffuse reflectance spectrometry) will be conducted throughout the 4 visits. Biopsies will be taken at various time points.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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VL+UVA1

Participants will be treated with VL + UVA1 light source

Group Type OTHER

Light Source B: Visible Light solar simulator (VL + UVA1)

Intervention Type DEVICE

Patients will be radiated with light source B (Visible light solar simulator)

Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)

Intervention Type DEVICE

Patients will be radiated with light source A (Visible light solar simulator closer match to sunlight)

Interventions

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Light Source B: Visible Light solar simulator (VL + UVA1)

Patients will be radiated with light source B (Visible light solar simulator)

Intervention Type DEVICE

Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)

Patients will be radiated with light source A (Visible light solar simulator closer match to sunlight)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy individuals age 18 and older
* Fitzpatrick skin phototype (SPT) I-VI, 7 with SPT I-III and 7 with SPT IV-VI, with normal healthy skin
* Able to understand the requirements of the study and its associated risks
* Able to complete and sign a consent form
* Willing and able to refrain from any medications or herbal supplements during the duration of the study, unless permitted by the investigator
* Agrees to refrain from using any new topical skin care products, laundry detergents, or fragrances while participating in the study
* Has not had excessive sun exposure for 7 days prior to enrollment in the study

Exclusion Criteria

* Recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post-inflammatory hyperpigmentation
* History of relevant skin conditions such as atopic dermatitis, eczema, or sunburn on any part of the body
* History of photodermatoses or photosensitivity disorders
* History of melanoma or non-melanoma skin cancers
* Use of tanning parlors or exposure of the irradiated sites to sun light during the duration of the study
* Use of topical or systemic treatment that is likely to interfere with assessment, study results, or pose safety concerns
* Subjects with a tendency to bleed excessively
* Known allergies to anesthetics (lidocaine) or anaphylaxis treatment (epinephrine)
* History of hypertrophic scarring or keloid formation
* Use of any photosensitizing medication within the visible light range or additional medication at the discretion of the investigator \[examples include - but not limited to - thiazide diuretics, regular use of NSAIDs, hydroxychloroquine, or voriconazole
* A woman who is lactating, pregnant, or planning to become pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Indermeet Kohli

Associate Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Henry Ford Medical Center

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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14869

Identifier Type: -

Identifier Source: org_study_id

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