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

Not Applicable

Completed

• Conditions: Photoaging; Hyperpigmentation; Rhytides
• Interventions: Combination Product: vehicle; Combination Product: 5% red maple leaf extract; Combination Product: 1% red maple leaf extract in cream base

• Registration Number: NCT04586816
• Lead Sponsor: Integrative Skin Science and Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-10
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Study First Submitted: 2020-05-11
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-09
• Last Update Submitted: 2020-10-09
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vehicle only-placebo	vehicle	Vehicle cream base containing no maple leaf extract to be applied twice daily to the face
5% red maple leaf extract	5% red maple leaf extract	lotion preparation with 5% red maple leaf extract to be applied twice daily to the face
1% red maple leaf extract	1% red maple leaf extract in cream base	lotion preparation with 1% red maple leaf extract to be applied twice daily to the face

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States