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History of Changes for Study: NCT04586816
Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
Latest version (submitted October 9, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 9, 2020 None (earliest Version on record)
Comparison Format:

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Study NCT04586816
Submitted Date:  October 9, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 005 (Sivamani)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Completed
Study Start: September 10, 2019
Primary Completion: January 15, 2020 [Actual]
Study Completion: January 15, 2020 [Actual]
First Submitted: May 11, 2020
First Submitted that
Met QC Criteria:
October 9, 2020
First Posted: October 14, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 9, 2020
Last Update Posted: October 14, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Integrative Skin Science and Research
Responsible Party: Sponsor
Collaborators: Verdure Sciences
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Photoaging
Hyperpigmentation
Rhytides
Keywords: maple leaf extract
skincare
photoaging
hyperpigmentation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Healthy females ages 30-70 with Fitzpatrick skin type I-IV
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 19 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: vehicle only-placebo
Vehicle cream base containing no maple leaf extract to be applied twice daily to the face
Combination Product: vehicle
vehicle cream base only
Experimental: 1% red maple leaf extract
lotion preparation with 1% red maple leaf extract to be applied twice daily to the face
Combination Product: 1% red maple leaf extract in cream base
1% red maple leaf extract is combined in a cream base
Experimental: 5% red maple leaf extract
lotion preparation with 5% red maple leaf extract to be applied twice daily to the face
Combination Product: 5% red maple leaf extract
5% red maple leaf extract is combined in a cream base
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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)
2. 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
3. Erythema on SkinColorCatch
[ Time Frame: At 4 weeks (end of study) ]

Assessment of erythema based on SkinColorCatch (arbitrary units set by technology)
4. 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
Secondary Outcome Measures:
1. 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]
2. 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)
Open or close this module Eligibility
Minimum Age: 30 Years
Maximum Age: 70 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: Yes
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.
Open or close this module Contacts/Locations
Study Officials: Raja K Sivamani, MD
Principal Investigator
Integrative Skin Science and Research
Locations: United States, California
Integrative Skin Science and Research
Sacramento, California, United States, 95815
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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