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

NCT04586816 | Completed

• 1 other identifier: 005 (Sivamani)
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Photoaging; Hyperpigmentation; Rhytides

Keywords

maple leaf extract; skincare; photoaging; hyperpigmentation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Centrofacial redness

  At 4 weeks (end of study)

• Appearance of wrinkles

  At 4 weeks (end of study)

Study Arms (3)

vehicle only-placebo

PLACEBO COMPARATOR

Vehicle cream base containing no maple leaf extract to be applied twice daily to the face

Combination Product: vehicle

1% red maple leaf extract

EXPERIMENTAL

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

5% red maple leaf extract

EXPERIMENTAL

lotion preparation with 5% red maple leaf extract to be applied twice daily to the face

Combination Product: 5% red maple leaf extract

Interventions

1% red maple leaf extract in cream base COMBINATION_PRODUCT

1% red maple leaf extract is combined in a cream base

1% red maple leaf extract

5% red maple leaf extract COMBINATION_PRODUCT

5% red maple leaf extract is combined in a cream base

5% red maple leaf extract

vehicle COMBINATION_PRODUCT

vehicle cream base only

vehicle only-placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• Verdure Sciences: collaborator

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Raja K Sivamani, MD

  Integrative Skin Science and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy females ages 30-70 with Fitzpatrick skin type I-IV

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: October 14, 2020
• Study Start: September 10, 2019
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

US (1)