PhotoagingNCT04586816
Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
A study testing 1% red maple leaf extract in cream base and 5% red maple leaf extract in people with Photoaging and Hyperpigmentation, run by Integrative Skin Science and Research at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photoaging, Hyperpigmentation, Rhytides
- What is being tested?
- 1% red maple leaf extract in cream base and 5% red maple leaf extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2019to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females aged 30-70
- Individuals with Fitzpatrick skin type I-IV
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research
Sacramento, California, 95815
About this study
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.
- Conditions
- Photoaging, Hyperpigmentation, Rhytides
- Being tested
- 1% red maple leaf extract in cream base, 5% red maple leaf extract, vehicle
- Keywords
- maple leaf extract, skincare, photoaging, hyperpigmentation
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% red maple leaf extract in cream baseCombination product
1% red maple leaf extract is combined in a cream base
5% red maple leaf extractCombination product
5% red maple leaf extract is combined in a cream base
vehicleCombination product
vehicle cream base only
| Study group | Role | What they receive |
|---|---|---|
| vehicle only-placebo | Placebo comparator | Vehicle cream base containing no maple leaf extract to be applied twice daily to the face Receives: Combination Product: vehicle |
| 1% red maple leaf extract | Experimental | lotion preparation with 1% red maple leaf extract to be applied twice daily to the face Receives: Combination Product: 1% red maple leaf extract in cream base |
| 5% red maple leaf extract | Experimental | lotion preparation with 5% red maple leaf extract to be applied twice daily to the face Receives: Combination Product: 5% red maple leaf extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigmentation on SkinColorCatch
Assessment of pigmentation based on melanin measurement on SkinColorCatch (arbitrary units set by technology)
Measured: At 4 weeks (end of study)
Clinical grading of Hyperpigmentation
Assessment of hyperpigmentation based on clinical grading (categories 0-5) by blinded evaluator
Measured: At 4 weeks (end of study)
Erythema on SkinColorCatch
Assessment of erythema based on SkinColorCatch (arbitrary units set by technology)
Measured: At 4 weeks (end of study)
Clinical grading of Erythema
Assessment of erythema based on clinical grading (categories 0-5) by blinded evaluator
Measured: At 4 weeks (end of study)
Secondary outcomes (2)
Centrofacial redness
Image-based analysis of redness [Skinmap level Degree of Intensity (%) on BTBP Clarity Research 3D System]
Measured: At 4 weeks (end of study)
Appearance of wrinkles
Image-based analysis of wrinkles (Average severity - unitless on BTBP Clarity Research 3D System)
Measured: At 4 weeks (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start10 Sep 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy females ages 30-70 with Fitzpatrick skin type I-IV
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Verdure Sciences
- Responsible party
- Sponsor
- Investigators
- Raja K Sivamani, MD, Principal investigator, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586816
- Sponsor's protocol ID
- 005 (Sivamani)
- Status last verified
- Oct 2020
- First submitted
- 11 May 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
- ClinicalTrials.gov ID
- NCT04586816
- Acronym / sponsor ID
- 005 (Sivamani)
- Conditions
- Photoaging, Hyperpigmentation, Rhytides
- Keywords
- maple leaf extract, skincare, photoaging, hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Verdure Sciences
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Healthy females ages 30-70 with Fitzpatrick skin type I-IV
| Arm | Type | Receives |
|---|---|---|
| vehicle only-placebo | Placebo comparator | Combination Product: vehicleVehicle cream base containing no maple leaf extract to be applied twice daily to the face |
| 1% red maple leaf extract | Experimental | Combination Product: 1% red maple leaf extract in cream baselotion preparation with 1% red maple leaf extract to be applied twice daily to the face |
| 5% red maple leaf extract | Experimental | Combination Product: 5% red maple leaf extractlotion preparation with 5% red maple leaf extract to be applied twice daily to the face |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females aged 30-70
- Individuals with Fitzpatrick skin type I-IV
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% red maple leaf extract in cream base1% red maple leaf extract is combined in a cream base | Combination product | 1% red maple leaf extract |
| 5% red maple leaf extract5% red maple leaf extract is combined in a cream base | Combination product | 5% red maple leaf extract |
| vehiclevehicle cream base only | Combination product | vehicle only-placebo |
Primary outcome
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
2 secondary outcomes
Centrofacial redness
Time frame: At 4 weeks (end of study)
Appearance of wrinkles
Time frame: At 4 weeks (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja K Sivamani, MD principal investigator
Integrative Skin Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1% red maple leaf extract in cream base and 5% red maple leaf extract in people with Photoaging and Hyperpigmentation, run by Integrative Skin Science and Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pigmentation on SkinColorCatch (time frame: At 4 weeks (end of study)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.