Skip to main content
OpenTrials
Completed

NCT Number: NCT04586816

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1% red maple leaf extract in cream base

Combination Product

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

5% red maple leaf extract

Combination Product

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

Vehicle

Combination Product

vehicle cream base only

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Integrative Skin Science and Research

Industry

Collaborators

  • Verdure Sciences

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.