Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
NCT ID: NCT04586816
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2019-09-10
2020-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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vehicle only-placebo
Vehicle cream base containing no maple leaf extract to be applied twice daily to the face
vehicle
vehicle cream base only
1% red maple leaf extract
lotion preparation with 1% red maple leaf extract to be applied twice daily to the face
1% red maple leaf extract in cream base
1% red maple leaf extract is combined in a cream base
5% red maple leaf extract
lotion preparation with 5% red maple leaf extract to be applied twice daily to the face
5% red maple leaf extract
5% red maple leaf extract is combined in a cream base
Interventions
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1% red maple leaf extract in cream base
1% red maple leaf extract is combined in a cream base
5% red maple leaf extract
5% red maple leaf extract is combined in a cream base
vehicle
vehicle cream base only
Eligibility Criteria
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Inclusion Criteria
* Individuals with Fitzpatrick skin type I-IV
Exclusion Criteria
* Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator
* Individuals who have participated in any other clinical studies using the same test sites (face) and hand in the past 14 days
* Individuals who are pregnant, breast feeding or planning a pregnancy within one month. (There is no concern for risk to fetus but pregnancy can alter skin pigmentation).
* Female volunteers who have started a new hormonal birth control agent or had a change in their hormonal birth control agent within the past 60 days
* Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
* Individuals who are currently using or during the past 30 days have used a retinoid such as Retin A, or other Rx/OTC Retinyl A or currently using or during the past 14 days have used hydroquinone (skin lightening)
* Individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed
* Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator.
30 Years
70 Years
FEMALE
Yes
Sponsors
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Verdure Sciences
INDUSTRY
Integrative Skin Science and Research
INDUSTRY
Responsible Party
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Principal Investigators
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Raja K Sivamani, MD
Role: PRINCIPAL_INVESTIGATOR
Integrative Skin Science and Research
Locations
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Integrative Skin Science and Research
Sacramento, California, United States
Countries
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Other Identifiers
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005 (Sivamani)
Identifier Type: -
Identifier Source: org_study_id
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