- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03594721
Clinical Trial Evaluation of a Test Serum Post HEV (High Energy Visible) Light Exposure
September 5, 2018 updated by: Allergan
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Virginia Beach, Virginia, United States, 23462
- McDaniel Institute of Anti Aging Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fitzpatrick Skin Types I-III
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.
|
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.
|
Experimental: Fitzpatrick Skin Types IV-V
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Photographs for detection of changes in the treatment areas.
Time Frame: Baseline, Day 11
|
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.
Time Frame: Baseline, Day 11
|
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.
Time Frame: Baseline, Day 11
|
Punch biopsies will be taken from the 3 different areas on the lower back for histological evaluation.
|
Baseline, Day 11
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2018
Primary Completion (Actual)
August 30, 2018
Study Completion (Actual)
August 30, 2018
Study Registration Dates
First Submitted
June 25, 2018
First Submitted That Met QC Criteria
July 19, 2018
First Posted (Actual)
July 20, 2018
Study Record Updates
Last Update Posted (Actual)
September 7, 2018
Last Update Submitted That Met QC Criteria
September 5, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- SKM18-MARV-HEV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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