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

• ClinicalTrials.gov Identifier: NCT04586816
• Recruitment Status: Completed
• First Posted: October 14, 2020
• Last Update Posted: October 14, 2020
• Sponsor: Integrative Skin Science and Research
• Collaborator: Verdure Sciences
• Information provided by (Responsible Party): Integrative Skin Science and Research

Tracking Information

• First Submitted Date: May 11, 2020
• First Posted Date: October 14, 2020
• Last Update Posted Date: October 14, 2020
• Actual Study Start Date: September 10, 2019
• Actual Primary Completion Date: January 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 9, 2020)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 9, 2020)

• Centrofacial redness [ Time Frame: 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 [ Time Frame: At 4 weeks (end of study) ]
  Image-based analysis of wrinkles (Average severity - unitless on BTBP Clarity Research 3D System)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
• Official Title: Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Healthy females ages 30-70 with Fitzpatrick skin type I-IV

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition

• Photoaging
• Hyperpigmentation
• Rhytides

Intervention

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

Study Arms

• Placebo Comparator: vehicle only-placebo
  Vehicle cream base containing no maple leaf extract to be applied twice daily to the face
  Intervention: Combination Product: vehicle
• Experimental: 1% red maple leaf extract
  lotion preparation with 1% red maple leaf extract to be applied twice daily to the face
  Intervention: Combination Product: 1% red maple leaf extract in cream base
• Experimental: 5% red maple leaf extract
  lotion preparation with 5% red maple leaf extract to be applied twice daily to the face
  Intervention: Combination Product: 5% red maple leaf extract

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 9, 2020): 19
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 15, 2020
• Actual Primary Completion Date: January 15, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 30 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04586816
• Other Study ID Numbers: 005 (Sivamani)
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Integrative Skin Science and Research
• Original Responsible Party: Same as current
• Current Study Sponsor: Integrative Skin Science and Research
• Original Study Sponsor: Same as current
• Collaborators: Verdure Sciences

Investigators

• Principal Investigator: Raja K Sivamani, MD; Integrative Skin Science and Research

• PRS Account: Integrative Skin Science and Research
• Verification Date: October 2020