Visible Light Phototesting for Skin Health

Overseen By Indermeet Kohli, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Must not be taking: Photosensitizers, NSAIDs, Hydroxychloroquine, others

Disqualifiers: Vitiligo, Melasma, Eczema, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications or herbal supplements during the study, unless the investigator allows it. The trial requires participants to refrain from using any photosensitizing medications or other medications that might interfere with the study.

Is visible light phototesting safe for human skin?

Visible light combined with UVA1 can cause skin redness (erythema) and pigmentation, especially in individuals with darker skin tones. While these effects are known, there are no specific safety guidelines for protection against this type of light exposure. ^{1 2 3 4 5}

How does the Visible Light Phototesting treatment differ from other treatments for skin health?

Visible Light Phototesting is unique because it uses a small handheld device with high-intensity LED light to test skin reactions to visible light, which is not commonly used in standard phototesting. This approach is novel as it focuses on the effects of visible light, which can cause pigmentation and erythema (redness) in different skin types, unlike traditional methods that primarily focus on ultraviolet light. ^{3 4 5 6 7}

What data supports the effectiveness of the Visible Light solar simulator treatment for skin health?

Recent studies have shown that visible light (VL) can cause more intense and longer-lasting pigmentation in dark-skinned individuals and can induce redness in light-skinned individuals, suggesting that VL combined with UVA1 has significant effects on the skin. This indicates that the treatment using VL + UVA1 may have potential benefits for skin health by influencing pigmentation and redness. ^{3 4 5 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 with any skin type, who haven't been in strong sun recently. They must understand the study and not take certain meds or use new skin products during the trial. It's not for those prone to heavy bleeding, allergic to specific anesthetics, have a history of abnormal scarring, are pregnant/lactating/planning pregnancy, using photosensitizing drugs or treatments that affect results.

Inclusion Criteria

My skin type is within the range of very light to very dark.

Has not had excessive sun exposure for 7 days prior to enrollment in the study

Able to complete and sign a consent form

Exclusion Criteria

History of photodermatoses or photosensitivity disorders

I am not taking any medication that increases sensitivity to light.

Known allergies to anesthetics (lidocaine) or anaphylaxis treatment (epinephrine)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive VL+UVA1 irradiation with different light sources on the opposite sides of their back. Non-invasive measurements and biopsies are conducted.

2 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of erythema and pigmentation.

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Visible Light solar simulator closer match to sunlight (VL +UVA1)
• Visible Light solar simulator (VL + UVA1)

Trial Overview The study tests two types of visible light solar simulators on skin: one closer to natural sunlight (VL+UVA1) and another standard version (VL+UVA1). The goal is to see how different light compositions affect biological responses like redness and pigmentation changes in various skin types.

How Is the Trial Designed?

Group I: VL+UVA1 Experimental Treatment 2 Interventions

Participants will be treated with VL + UVA1 light source

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Rapid and Cost-Effective Device for Testing Minimal Erythema Dose. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Validation of a novel high-intensity LED light source for skin phototesting at 365 nm. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Photosensitivity in HIV-infected individuals. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Controlled drug trials in photodermatoses. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Visible Light and the Skin. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an economical sunlamp that emits a near solar UV power spectrum for conducting photoimmunological and sunscreen immune protection studies. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Kinetics of UV-erythema in normal subjects. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Spectral comparison of solar simulators and sunlight. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

[Light test on human skin]. [2006]