Clinical trial NCT04586816: Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
Official title: Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photoaging
Hyperpigmentation
Rhytides
Keywords: maple leaf extract
skincare
photoaging
hyperpigmentation
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Verdure Sciences
First posted: 2020-10-14
Enrollment: 19
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy females ages 30-70 with Fitzpatrick skin type I-IV
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pigmentation on SkinColorCatch
timeFrame: At 4 weeks (end of study)
measure: Clinical grading of Hyperpigmentation
timeFrame: At 4 weeks (end of study)
measure: Erythema on SkinColorCatch
timeFrame: At 4 weeks (end of study)
measure: Clinical grading of Erythema
timeFrame: At 4 weeks (end of study)
Secondary outcomes:
measure: Centrofacial redness
timeFrame: At 4 weeks (end of study)
measure: Appearance of wrinkles
timeFrame: At 4 weeks (end of study)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
affiliation: Integrative Skin Science and Research
name: Raja K Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References: