Clinical Trial Evaluation of a Test Serum Post HEV (High Energy Visible) Light Exposure

Study Overview
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Brief Summary
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To evaluate 10 days of pretreatment with a serum (Test Product/Marvel AM) to the lower back, followed by a single exposure of 90J/cm2 HEV (High Energy Visible) light {400-450nm wavelengths} in healthy male or female volunteers.

Official Title
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Clinical Trial Evaluation of a Test Serum Post HEV (High Energy Visible) Light Exposure

Conditions
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Blue Light Damage

Intervention / Treatment
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* Other: Marvel AM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers can be male or female, 18 to 65 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation. Volunteers must sign a written informed consent. Volunteers must fall within Fitzpatrick Skin Type I-V. Volunteers must be willing to avoid sun exposure to the study treatment area (lower back) for the duration of the study. Volunteers must commit to meeting all study requirements, including 11 days of sequential office visits for product application, HEV exposure, biopsy and suture removal. Exclusion Criteria: Volunteers who are pregnant, breast feeding or planning a pregnancy during the study period. Have used within the month before inclusion, any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, insulin, antihistamines, antihypertensive, antibiotics-e.g quinolone, tetracycline, thiazides, fluoroquinolones), or any medication known to cause abnormal responses to HEV light exposure (e.g. vitamin A derivatives, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study. Volunteers who have damaged skin in close proximity to test sites (e.g. sunburn, uneven skin tones, tattoos, scars or other disfigurations) Volunteers who have used a prescription hydroquinone, non-hydroquinone skin lightening or brightening agent, or like product in the test area, within the past 3 months. Volunteers who have used a non-prescription cosmetic anti-aging or skin lightening product known to affect dyschromia or hyperpigmentation, in the test area, within the past 4 weeks. Volunteers who have a history of scarring, hypertrophic scarring or keloid formation anywhere on their body. Volunteers with a known sensitivity to lidocaine or epinephrine. Volunteers who are unwilling or unable to comply with the requirements of the protocol, including ability to complete all study visits within the proscribed study visit window for any reason(s). Volunteers with any disorder that may prevent compliance, such as history of chronic alcohol or drug abuse, significant mental or nervous disorder or other illness that would, in the evaluator's opinion, interfere with the study. Have participated, or are participating in, another study within the past 4 weeks. Any dermatologic disorder which, in the investigator's opinion, may interfere with the accurate evaluation of the study treatment area (lower back), but not limited to melasma, any active inflammatory skin condition (i.e. post inflammatory hyperpigmentation), severe acne vulgaris, acne conglobata, acne fulminans, seborrheic dermatitis, and lupus erythematosus. Volunteers who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products. Concurrent therapy with any medication either topical or oral which, in the investigator's opinion, may interfere with evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fitzpatrick Skin Types I-III<br>Volunteers will return to the clinic after Baseline for 10 additional, consecutive days for study staff to apply approximately 2 mg/cm2 or 50 µL of test product to the appropriate 5x5cm2 test location on the lower back. Volunteers will have digital images of the three (3) areas on the lower back that comprise the entire test region taken at Baseline, and 24hrs post 90J/cm2 HEV light exposure. | Other: Marvel AM<br>* Study staff will perform each application of approximately 2 mg/cm2 or 50 µL of test product to the appropriate 5x5cm2 test location on the lower back at each of ten sequential visits.<br>|
| Experimental: Fitzpatrick Skin Types IV-V<br>Volunteers will return to the clinic after Baseline for 10 additional, consecutive days for study staff to apply approximately 2 mg/cm2 or 50 µL of test product to the appropriate 5x5cm2 test location on the lower back. Volunteers will have digital images of the three (3) areas on the lower back that comprise the entire test region taken at Baseline, and 24hrs post 90J/cm2 HEV light exposure. | Other: Marvel AM<br>* Study staff will perform each application of approximately 2 mg/cm2 or 50 µL of test product to the appropriate 5x5cm2 test location on the lower back at each of ten sequential visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographs for detection of changes in the treatment areas. | Photographic images of the lower back, will be captured utilizing a digital system. Photos may be taken from multiple angles to allow for easy detection of changes in the treatment areas. | Baseline, Day 11 | 
| Chromamemter instrument will be used to assess the change of color on the skin. | Chromameter instrument will be used to measure color on the skin. | Baseline, Day 11 | 
| Punch biopsies will be taken from the 3 different areas on the lower back to evaluate histological changes. | Punch biopsies will be taken from the 3 different areas on the lower back for histological evaluation. | Baseline, Day 11 |