Clinical trial NCT03594721: Clinical Trial Evaluation of a Test Serum Post HEV (High Energy Visible) Light Exposure
Official title: Clinical Trial Evaluation of a Test Serum Post HEV (High Energy Visible) Light Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blue Light Damage
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-07-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Photographs for detection of changes in the treatment areas.
timeFrame: Baseline, Day 11
measure: Chromamemter instrument will be used to assess the change of color on the skin.
timeFrame: Baseline, Day 11
measure: Punch biopsies will be taken from the 3 different areas on the lower back to evaluate histological changes.
timeFrame: Baseline, Day 11
Secondary outcomes:
Other outcomes:
Locations:
city: Virginia Beach
country: United States
facility: McDaniel Institute of Anti Aging Research
state: Virginia
Study officials:
affiliation: Allergan
name: Elizabeth Makino
role: STUDY_DIRECTOR
References: