Clinical trial NCT05964907: Optimizing Phototesting and Investigating Photobiology of Visible Light
Official title: Optimizing Phototesting and Investigating Photobiology of Visible Light
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Erythema assessment for all 14 participants.
timeFrame: Visit 1 (Day 0)
measure: Erythema assessment for all participants
timeFrame: Visit 2 (Day 1)
measure: Erythema assessment
timeFrame: Visit 3 (Day 7)
measure: Erythema assessment for 14 participants
timeFrame: Visit 4 (Day 14)
measure: Erythema assessment for all 14 participants
timeFrame: Visit 1 (Day 0)
measure: Erythema assessment for all 14 participants
timeFrame: Visit 2 (Day 1)
measure: Erythema assessment for all 14 participants
timeFrame: Visit 3 (Day 7)
measure: Erythema assessment for all 14 participants
timeFrame: Visit 4 (Day 14)
measure: Pigmentation assessment for all 14 participants.
timeFrame: Visit 1 (day 0)
measure: Pigmentation assessment for all 14
timeFrame: Visit 2 (Day 1)
measure: Pigmentation assessment for 14 participants
timeFrame: Visit 3 (Day 7)
measure: Pigmentation assessment for all 14
timeFrame: Visit 4 (Day 14)
measure: Pigmentation assessment for all 14 participants..
timeFrame: Visit 1 (day 0)
measure: Pigmentation assessment for all 14 participants
timeFrame: Visit 2 (Day 1)
measure: Pigmentation assessment for all 14 participants
timeFrame: Visit 3 (Day 7)
measure: Pigmentation assessment for all 14 participants
timeFrame: Visit 4 (Day 14)
Secondary outcomes:
measure: Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
timeFrame: Visit 1 (Day 0)
measure: Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
timeFrame: Visit 2 (Day 1)
measure: Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
timeFrame: Visit 3 (Day 7)
measure: RNA sequencing for 8 participants
timeFrame: Visit 2 (Day 1)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
Study officials:
References: