Optimizing Phototesting and Investigating Photobiology of Visible Light

Henry Ford Health

Status

Active, not recruiting

Conditions

Healthy

Treatments

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

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05964907

14869

Details and patient eligibility

About

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.

Full description

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.

Enrollment

14 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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