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

Integrative Skin Science and Research

Status: Completed

Conditions: Hyperpigmentation; Photoaging; Rhytides

Treatments: Combination Product: 5% red maple leaf extract; Combination Product: vehicle; Combination Product: 1% red maple leaf extract in cream base

Study type: Interventional

Funder types: Industry

Identifiers

NCT04586816

005 (Sivamani)

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

19 participants in 3 patient groups, including a placebo group

vehicle only-placebo

Placebo Comparator group

Description:

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

Treatment:

Combination Product: vehicle

1% red maple leaf extract

Experimental group

Description:

lotion preparation with 1% red maple leaf extract to be applied twice daily to the face

Treatment:

Combination Product: 1% red maple leaf extract in cream base

5% red maple leaf extract

Experimental group

Description:

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

Treatment:

Combination Product: 5% red maple leaf extract