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

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.

Study Overview

• Status: Completed
• Conditions: Hyperpigmentation; Photoaging; Rhytides
• Intervention / Treatment: Combination product: vehicle; Combination product: 1% red maple leaf extract in cream base; Combination product: 5% red maple leaf extract

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pigmentation on SkinColorCatch	Assessment of pigmentation based on melanin measurement on SkinColorCatch (arbitrary units set by technology)	At 4 weeks (end of study)
Clinical grading of Hyperpigmentation	Assessment of hyperpigmentation based on clinical grading (categories 0-5) by blinded evaluator	At 4 weeks (end of study)
Erythema on SkinColorCatch	Assessment of erythema based on SkinColorCatch (arbitrary units set by technology)	At 4 weeks (end of study)
Clinical grading of Erythema	Assessment of erythema based on clinical grading (categories 0-5) by blinded evaluator	At 4 weeks (end of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Centrofacial redness	Image-based analysis of redness [Skinmap level Degree of Intensity (%) on BTBP Clarity Research 3D System]	At 4 weeks (end of study)
Appearance of wrinkles	Image-based analysis of wrinkles (Average severity - unitless on BTBP Clarity Research 3D System)	At 4 weeks (end of study)

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Verdure Sciences
• Investigators: Principal Investigator: Raja K Sivamani, MD, Integrative Skin Science and Research

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: hyperpigmentation; photoaging; maple leaf extract; skincare
• Additional Relevant MeSH Terms: Pigmentation Disorders; Skin Diseases; Hyperpigmentation
• Other Study ID Numbers: 005 (Sivamani)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No