Blue Light DamageNCT03594721
Clinical Trial Evaluation of a Test Serum Post HEV (High Energy Visible) Light Exposure
A study testing Marvel AM in people with Blue Light Damage, run by Allergan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blue Light Damage
- What is being tested?
- Marvel AM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
McDaniel Institute of Anti Aging Research
Virginia Beach, Virginia, 23462
About this study
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.
- Conditions
- Blue Light Damage
- Being tested
- Marvel AM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marvel AMOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fitzpatrick Skin Types I-III | Experimental | 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. Receives: Other: Marvel AM |
| Fitzpatrick Skin Types IV-V | Experimental | 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. Receives: Other: Marvel AM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start6 Aug 2018
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blue Light DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Makino, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594721
- Sponsor's protocol ID
- SKM18-MARV-HEV
- Status last verified
- Sep 2018
- First submitted
- 25 Jun 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Evaluation of a Test Serum Post HEV (High Energy Visible) Light Exposure
- ClinicalTrials.gov ID
- NCT03594721
- Acronym / sponsor ID
- SKM18-MARV-HEV
- Conditions
- Blue Light Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitzpatrick Skin Types I-III | Experimental | Other: Marvel AMVolunteers 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. |
| Fitzpatrick Skin Types IV-V | Experimental | Other: Marvel AMVolunteers 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marvel AMStudy 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. | Other | Fitzpatrick Skin Types I-III, Fitzpatrick Skin Types IV-V |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Makino study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marvel AM in people with Blue Light Damage, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photographs for detection of changes in the treatment areas. (time frame: Baseline, Day 11). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.