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Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging

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ClinicalTrials.gov Identifier: NCT04586816
Recruitment Status : Completed
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Verdure Sciences
Information provided by (Responsible Party):
Integrative Skin Science and Research

Study Description
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Brief Summary:
Recent research has reported that the maple leaf extract exhibits anti-aging effects by inhibiting elastase activity, thereby preventing the breakdown of elastin and interfering with the formation of wrinkles. Red maple leaf extract contains phenolic compounds known as glucitol-core-containing gallotannins (GCGs) which help reduce the appearance of wrinkles and may decrease skin inflammation, dark spots and pigmentation. The objective of this study is to examine the effects of topical Maplifa on the cosmetic appearance of facial lines, redness and skin tone.

Condition or disease Intervention/treatment Phase
Photoaging Hyperpigmentation Rhytides Combination Product: 1% red maple leaf extract in cream base Combination Product: 5% red maple leaf extract Combination Product: vehicle Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Healthy females ages 30-70 with Fitzpatrick skin type I-IV
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
Actual Study Start Date : September 10, 2019
Actual Primary Completion Date : January 15, 2020
Actual Study Completion Date : January 15, 2020
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: vehicle only-placebo
Vehicle cream base containing no maple leaf extract to be applied twice daily to the face
 Combination Product: vehicle
vehicle cream base only
Experimental: 1% red maple leaf extract
lotion preparation with 1% red maple leaf extract to be applied twice daily to the face
 Combination Product: 1% red maple leaf extract in cream base
1% red maple leaf extract is combined in a cream base
Experimental: 5% red maple leaf extract
lotion preparation with 5% red maple leaf extract to be applied twice daily to the face
 Combination Product: 5% red maple leaf extract
5% red maple leaf extract is combined in a cream base


Outcome Measures
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Primary Outcome Measures :
  1. Pigmentation on SkinColorCatch [ Time Frame: At 4 weeks (end of study) ]
    Assessment of pigmentation based on melanin measurement on SkinColorCatch (arbitrary units set by technology)

  2. Clinical grading of Hyperpigmentation [ Time Frame: At 4 weeks (end of study) ]
    Assessment of hyperpigmentation based on clinical grading (categories 0-5) by blinded evaluator

  3. Erythema on SkinColorCatch [ Time Frame: At 4 weeks (end of study) ]
    Assessment of erythema based on SkinColorCatch (arbitrary units set by technology)

  4. Clinical grading of Erythema [ Time Frame: At 4 weeks (end of study) ]
    Assessment of erythema based on clinical grading (categories 0-5) by blinded evaluator


Secondary Outcome Measures :
  1. Centrofacial redness [ Time Frame: At 4 weeks (end of study) ]
    Image-based analysis of redness [Skinmap level Degree of Intensity (%) on BTBP Clarity Research 3D System]

  2. Appearance of wrinkles [ Time Frame: At 4 weeks (end of study) ]
    Image-based analysis of wrinkles (Average severity - unitless on BTBP Clarity Research 3D System)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females aged 30-70
  • Individuals with Fitzpatrick skin type I-IV

Exclusion Criteria:

  • Individuals who have been on any medication that has caused a change in skin pigmentation based on the opinion of the investigator
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586816


Locations
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United States, California
Integrative Skin Science and Research
Sacramento, California, United States, 95815
Sponsors and Collaborators
Integrative Skin Science and Research
Verdure Sciences
Investigators
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Principal Investigator: Raja K Sivamani, MD Integrative Skin Science and Research
More Information
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Responsible Party: Integrative Skin Science and Research
ClinicalTrials.gov Identifier: NCT04586816    
Other Study ID Numbers: 005 (Sivamani)
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Integrative Skin Science and Research:
maple leaf extract
skincare
photoaging
hyperpigmentation
Additional relevant MeSH terms:
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Skin Diseases
Hyperpigmentation
Pigmentation Disorders