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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04586816
Recruitment Status : Completed
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Verdure Sciences
Information provided by (Responsible Party):
Integrative Skin Science and Research

Tracking Information
First Submitted Date  ICMJE May 11, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE September 10, 2019
Actual Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Photoaging
  • Hyperpigmentation
  • Rhytides
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2020)
19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 15, 2020
Actual Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04586816
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Integrative Skin Science and Research
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Integrative Skin Science and Research
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Verdure Sciences
Investigators  ICMJE
Principal Investigator: Raja K Sivamani, MD Integrative Skin Science and Research
PRS Account Integrative Skin Science and Research
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP