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

Primary Purpose

Photoaging, Hyperpigmentation, Rhytides

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

1% red maple leaf extract in cream base

5% red maple leaf extract

vehicle

About this trial

This is an interventional treatment trial for Photoaging focused on measuring maple leaf extract, skincare, photoaging, hyperpigmentation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

Integrative Skin Science and Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

vehicle only-placebo

1% red maple leaf extract

5% red maple leaf extract

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Pigmentation on SkinColorCatch

Assessment of pigmentation based on melanin measurement on SkinColorCatch (arbitrary units set by technology)

Clinical grading of Hyperpigmentation

Assessment of hyperpigmentation based on clinical grading (categories 0-5) by blinded evaluator

Erythema on SkinColorCatch

Assessment of erythema based on SkinColorCatch (arbitrary units set by technology)

Clinical grading of Erythema

Assessment of erythema based on clinical grading (categories 0-5) by blinded evaluator

Secondary Outcome Measures

Centrofacial redness

Image-based analysis of redness [Skinmap level Degree of Intensity (%) on BTBP Clarity Research 3D System]

Appearance of wrinkles

Image-based analysis of wrinkles (Average severity - unitless on BTBP Clarity Research 3D System)

Full Information

NCT ID

NCT04586816

First Posted

May 11, 2020

Last Updated

October 9, 2020

Sponsor

Integrative Skin Science and Research

Collaborators

Verdure Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04586816

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

September 10, 2019 (Actual)

Primary Completion Date

January 15, 2020 (Actual)

Study Completion Date

January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Integrative Skin Science and Research

Collaborators

Verdure Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Photoaging, Hyperpigmentation, Rhytides

Keywords

maple leaf extract, skincare, photoaging, hyperpigmentation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vehicle only-placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

1% red maple leaf extract

Arm Type

Experimental

Arm Description

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

Arm Title

5% red maple leaf extract

Arm Type

Experimental

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

1% red maple leaf extract in cream base

Intervention Description

1% red maple leaf extract is combined in a cream base

Intervention Type

Combination Product

Intervention Name(s)

5% red maple leaf extract

Intervention Description

5% red maple leaf extract is combined in a cream base

Intervention Type

Combination Product

Intervention Name(s)

vehicle

Intervention Description

vehicle cream base only

Primary Outcome Measure Information:

Title

Pigmentation on SkinColorCatch

Description

Assessment of pigmentation based on melanin measurement on SkinColorCatch (arbitrary units set by technology)

Time Frame

At 4 weeks (end of study)

Title

Clinical grading of Hyperpigmentation

Description

Assessment of hyperpigmentation based on clinical grading (categories 0-5) by blinded evaluator

Time Frame

At 4 weeks (end of study)

Title

Erythema on SkinColorCatch

Description

Assessment of erythema based on SkinColorCatch (arbitrary units set by technology)

Time Frame

At 4 weeks (end of study)

Title

Clinical grading of Erythema

Description

Assessment of erythema based on clinical grading (categories 0-5) by blinded evaluator

Time Frame

At 4 weeks (end of study)

Secondary Outcome Measure Information:

Title

Centrofacial redness

Description

Image-based analysis of redness [Skinmap level Degree of Intensity (%) on BTBP Clarity Research 3D System]

Time Frame

At 4 weeks (end of study)

Title

Appearance of wrinkles

Description

Image-based analysis of wrinkles (Average severity - unitless on BTBP Clarity Research 3D System)

Time Frame

At 4 weeks (end of study)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raja K Sivamani, MD

Organizational Affiliation

Integrative Skin Science and Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Integrative Skin Science and Research

City

Sacramento

State/Province

California

ZIP/Postal Code

95815

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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