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

Study Overview
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Brief Summary
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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.

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

Conditions
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Photoaging, Hyperpigmentation, Rhytides

Intervention / Treatment
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* Combination Product: 1% red maple leaf extract in cream base
* Combination Product: 5% red maple leaf extract
* Combination Product: vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Healthy females ages 30-70 with Fitzpatrick skin type I-IV
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: vehicle only-placebo<br>Vehicle cream base containing no maple leaf extract to be applied twice daily to the face | Combination Product: vehicle<br>* vehicle cream base only<br>|
| Experimental: 1% red maple leaf extract<br>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<br>* 1% red maple leaf extract is combined in a cream base<br>|
| Experimental: 5% red maple leaf extract<br>lotion preparation with 5% red maple leaf extract to be applied twice daily to the face | Combination Product: 5% red maple leaf extract<br>* 5% red maple leaf extract is combined in a cream base<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maple leaf extract, skincare, photoaging, hyperpigmentation