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

Photoaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04586816
• Other study ID #: 005 (Sivamani)
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: October 2020
• Source: Integrative Skin Science and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperpigmentation
• Photoaging
• Rhytides
• Skin Diseases

Intervention

Combination Product:
• 1% red maple leaf extract in cream base
1% red maple leaf extract is combined in a cream base
• 5% red maple leaf extract
5% red maple leaf extract is combined in a cream base
• vehicle
vehicle cream base only

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Verdure Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pigmentation on SkinColorCatch	Assessment of pigmentation based on melanin measurement on SkinColorCatch (arbitrary units set by technology)	At 4 weeks (end of study)
Primary	Clinical grading of Hyperpigmentation	Assessment of hyperpigmentation based on clinical grading (categories 0-5) by blinded evaluator	At 4 weeks (end of study)
Primary	Erythema on SkinColorCatch	Assessment of erythema based on SkinColorCatch (arbitrary units set by technology)	At 4 weeks (end of study)
Primary	Clinical grading of Erythema	Assessment of erythema based on clinical grading (categories 0-5) by blinded evaluator	At 4 weeks (end of study)
Secondary	Centrofacial redness	Image-based analysis of redness [Skinmap level Degree of Intensity (%) on BTBP Clarity Research 3D System]	At 4 weeks (end of study)
Secondary	Appearance of wrinkles	Image-based analysis of wrinkles (Average severity - unitless on BTBP Clarity Research 3D System)	At 4 weeks (end of study)