Status:
ACTIVE_NOT_RECRUITING
Optimizing Phototesting and Investigating Photobiology of Visible Light
Lead Sponsor:
Henry Ford Health System
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
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 differ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05964907
Start Date
October 6 2021
End Date
December 30 2026
Last Update
May 2 2025
Active Locations (1)
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1
Henry Ford Medical Center
Detroit, Michigan, United States, 48202