Skin ConditionNCT03487965
Evaluation of Skin Attributes Following Dietary Supplement Consumption
A study testing Low dose Polyphenol and High dose Polyphenol in people with Skin Condition, run by Access Business Group.
Trial summary
The study is to assess skin attributes of female subjects following 16 weeks of dietary supplement consumption. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Condition
- What is being tested?
- Low dose Polyphenol and High dose Polyphenol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2016to 28 Jun 2017
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a Caucasian or Asian (either Korean, Japanese, or Chinese) female between the ages of 30 and 65 years;
- Subject is overweight or moderately obese, with a BMI between 27 and 33;
- Subject is Caucasian and qualifies based on AGE Reader assessment that is at or greater than average for chronological age; OR is Asian and has an obtainable AGE Reader assessment on the left forearm. Screening AGE reader assessment will be done on the left inner forearm;
- Subject is willing to have fasting blood draws and urine collections at specified visits. At least nine hours fasting is required. Subject is allowed to drink water;
- Subject is willing to refrain from excessive sun exposure and/or the use of tanning beds;
- Subject is willing to use daily the provided facial SPF moisturizer and Purpose® cleansing bar;
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- Subject is taking well established, stable doses of prescription and nonprescription medications not indicated to treat a thyroid condition or diabetes;
- Subject is in generally good health as determined by the medical history and blood panel results in the opinion of the Principal Investigator;
- Subject is dependable and able to follow directions as outlined in the protocol;
- Subject agrees to complete and sign a Photography Release Form, providing consent for the capture of facial digital images for use in relation to this clinical study;
- Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
- Subject understands and is willing to sign an Informed Consent in conformance with 21 CFR Part 50: "Protection of Human Subjects."
Who cannot join
- Subject is pregnant, planning to become pregnant, or nursing;
- Subject is known to have, or at risk for, photosensitivity reactions (e.g. very sensitive to ultraviolet light);
- Subject has scars, tattoos, moles, age spots or rashes on the tested areas that the AGE Reader sensor and Cutometer® probe need to be placed;
- Subject takes prescription anticoagulants (this does not include a daily 81 mg dose of Aspirin);
- Subject has a history of any type of cancer and/or is currently undergoing treatment for any type of cancer;
- Subject has either a systolic blood pressure above 160 or a diastolic blood pressure above 100 at any time during the study;
- Subject has a thyroid condition;
- Subject is diabetic or taking any medication or herbal supplement to lower their blood glucose
About this study
Official title: A Randomized, Double Blinded, Placebo Controlled Clinical Study to Evaluate Skin Attributes Following Dietary Supplement Consumption
The study is to assess skin attributes of female subjects following 16 weeks of dietary supplement consumption.
Read the detailed description
This is a 16 week, randomized, double blind, placebo controlled study. Approximately 105 Caucasian and Asian (Korean, Japanese, or Chinese) female subjects will be enrolled. The following clinical assessments will be performed: (1)VISIA-CR™ digital photography; (2)AGE Reader SU measurements on the left cheek and left inner forearm; (3) Visual Analog Grading (VAS); (4) Corneometer measurements; and (5) Cutometer measurements. Subjects will return to the clinic at approximately 4 weeks, 8 weeks and 16 weeks from the baseline visit for similar measurements. A self-perception questionnaire will be administered at the conclusion of the study.
- Conditions
- Skin Condition
- Being tested
- Low dose Polyphenol, High dose Polyphenol, Placebo Control
- Keywords
- dicarbonyl compounds, skin elasticity, glycation
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose PolyphenolDietary supplement
botanical supplement with 25 mg polyphenol
High dose PolyphenolDietary supplement
botanical supplement with 13 mg polyphenol
Placebo ControlDietary supplement
inert tablet made to mimic the experimental tablets
| Study group | Role | What they receive |
|---|---|---|
| Low dose Polyphenol | Experimental | 130 mg of Aronia Extract with 120 mg of licorice root combination blend provided to subjects once per day for 16 weeks. Receives: Dietary Supplement: Low dose Polyphenol |
| High dose Polyphenol | Experimental | 200 mg of Aronia extract provided to subjects once per day for 16 weeks Receives: Dietary Supplement: High dose Polyphenol |
| Placebo control | Placebo comparator | Inert tablet provided to subjects once per day for 16 weeks Receives: Dietary Supplement: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Skin Autofluoresence
Change of accumulation of glycation as measured by validated autofluoresence measuring device (AGE Reader)
Measured: Change from baseline to 16 weeks, change from 8 weeks to 16 weeks
Secondary outcomes (1)
Skin elasticity
Relationship between elasticity and skin glycation; elasticity will be measured by cutometer
Measured: Change from baseline to 16 weeks; change from 8 weeks to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start28 Apr 2016
- Primary completion28 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ConditionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- individuals are assigned prospectively to two different interventions according to a protocol, to evaluate the effect of the interventions
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access Business Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Laboratories
- Responsible party
- Sponsor
- Investigators
- Anita L Cham, MD, Principal investigator, Clinical Research Laboraties, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487965
- Sponsor's protocol ID
- CRL119515
- Status last verified
- Apr 2018
- First submitted
- 29 Mar 2018
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Placebo Controlled Clinical Study to Evaluate Skin Attributes Following Dietary Supplement Consumption
- ClinicalTrials.gov ID
- NCT03487965
- Acronym / sponsor ID
- CRL119515
- Conditions
- Skin Condition
- Keywords
- dicarbonyl compounds, skin elasticity, glycation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Access Business GroupIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Laboratories
- Study start
- 28 Apr 2016 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 4 Apr 2018 (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.
The study is to assess skin attributes of female subjects following 16 weeks of dietary supplement consumption.
Detailed description
This is a 16 week, randomized, double blind, placebo controlled study. Approximately 105 Caucasian and Asian (Korean, Japanese, or Chinese) female subjects will be enrolled. The following clinical assessments will be performed: (1)VISIA-CR™ digital photography; (2)AGE Reader SU measurements on the left cheek and left inner forearm; (3) Visual Analog Grading (VAS); (4) Corneometer measurements; and (5) Cutometer measurements. Subjects will return to the clinic at approximately 4 weeks, 8 weeks and 16 weeks from the baseline visit for similar measurements. A self-perception questionnaire will be administered at the conclusion of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- individuals are assigned prospectively to two different interventions according to a protocol, to evaluate the effect of the interventions
| Arm | Type | Receives |
|---|---|---|
| Low dose Polyphenol | Experimental | Dietary Supplement: Low dose Polyphenol130 mg of Aronia Extract with 120 mg of licorice root combination blend provided to subjects once per day for 16 weeks. |
| High dose Polyphenol | Experimental | Dietary Supplement: High dose Polyphenol200 mg of Aronia extract provided to subjects once per day for 16 weeks |
| Placebo control | Placebo comparator | Dietary Supplement: Placebo ControlInert tablet provided to subjects once per day for 16 weeks |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is a Caucasian or Asian (either Korean, Japanese, or Chinese) female between the ages of 30 and 65 years;
- Subject is overweight or moderately obese, with a BMI between 27 and 33;
- Subject is Caucasian and qualifies based on AGE Reader assessment that is at or greater than average for chronological age; OR is Asian and has an obtainable AGE Reader assessment on the left forearm. Screening AGE reader assessment will be done on the left inner forearm;
- Subject is willing to have fasting blood draws and urine collections at specified visits. At least nine hours fasting is required. Subject is allowed to drink water;
- Subject is willing to refrain from excessive sun exposure and/or the use of tanning beds;
Key exclusion criteria (8 listed)
- Subject is pregnant, planning to become pregnant, or nursing;
- Subject is known to have, or at risk for, photosensitivity reactions (e.g. very sensitive to ultraviolet light);
- Subject has scars, tattoos, moles, age spots or rashes on the tested areas that the AGE Reader sensor and Cutometer® probe need to be placed;
- Subject takes prescription anticoagulants (this does not include a daily 81 mg dose of Aspirin);
- Subject has a history of any type of cancer and/or is currently undergoing treatment for any type of cancer;
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 |
|---|---|---|
| Low dose Polyphenolbotanical supplement with 25 mg polyphenol | Dietary supplement | Low dose Polyphenol |
| High dose Polyphenolbotanical supplement with 13 mg polyphenol | Dietary supplement | High dose Polyphenol |
| Placebo Controlinert tablet made to mimic the experimental tablets | Dietary supplement | Placebo control |
Primary outcome
Change of Skin Autofluoresence
Time frame: Change from baseline to 16 weeks, change from 8 weeks to 16 weeks
Change of accumulation of glycation as measured by validated autofluoresence measuring device (AGE Reader)
1 secondary outcome
Skin elasticity
Time frame: Change from baseline to 16 weeks; change from 8 weeks to 16 weeks
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 6 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Anita L Cham, MD principal investigator
Clinical Research Laboraties, LLC
Questions about this trial
What is this clinical trial studying?
A study testing Low dose Polyphenol and High dose Polyphenol in people with Skin Condition, run by Access Business Group.
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 12 inclusion and 8 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 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change of Skin Autofluoresence (time frame: Change from baseline to 16 weeks, change from 8 weeks to 16 weeks). 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 6 Apr 2018.