Skin HealthNCT03771807
Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults
A study testing Beauty From Within and Facial cleansing in people with Skin Health, run by Pharmanex at 1 site in United States.
Trial summary
Consumption of dietary supplements has been found to modulate skin health. Individual ingredients such as collagen peptides, lutein and ceramides have been shown to improve skin health. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Beauty From Within and Facial cleansing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 20 Jun 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 40 - 60 years of age
- Individuals must present with stable moderate signs of aging that does not change between the screening visit and the baseline visit 4 weeks later
- Subject is willing and able to participate in all aspects of the study
- Individuals must sign informed consent, photo release consent and confidentiality agreement
- Subject has a BMI > 19 and < 32
- Subject must be on a stable dose of chronic use medications for at least 3 months prior to study participation
- Subject who, in the opinion of the investigator, are free of any medical condition(s) that may interfere with study participation or affect study measures
Who cannot join
- Individuals that are being treated for cancer or have a history of facial skin cancer
- Individuals with sunburn, moderate to pronounced suntan, uneven skin tones, tattoos, scares or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results
- Any disease or condition of the skin that the investigator deems inappropriate for participation, including rosacea, eczema, psoriasis, and atopic dermatitis
- Individuals currently taking medications which in the opinion of the investigator may interfere with the study. This would include but not be limited to all oral corticosteroids, use of anti-inflammatory drugs more than 14 consecutive days, immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted), hormone replacement therapy and insulin, antibiotics or other topical drugs at the test sites
- Individuals with uncontrolled metabolic diseases such as diabetes (type I and II), hypertension, hyperthyroidism or hypothyroidism, severe chronic asthma, immunological disorders such as HIV, AIDS and systemic lupus erythematosus or mastectomy for cancer involving removal of lymph nodes
- Subject is taking skin, nail, and hair health promoting supplement orally (including products containing collagen and carotenoids)
Show all 15Show fewer
- Women known to be pregnant, nursing, or planning to become pregnant
- Individuals participating in other facial clinical trials
- Individuals who have routinely used alpha-hydroxy-acid (AHA) or a beta-hydroxy-acid (BHA) containing product within two weeks of baseline visit or Retin-A®, Retin-A Micro®, Renova®, Differin®, Avita®, Tazorac®, or Soriatane® within one month of baseline visit or have taken Accutane® within one year of baseline visit. Individuals who have used Retinol in the last six months prior to baseline visit
- Individuals with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules) at the test site
- Individuals who have had chemical peels or dermabrasion within the last six months prior to baseline visit
- Individuals who have sun tanned (sun or tanning beds) in the nude within the past 1 year prior to baseline visit
- Excessive alcohol use (>2 drinks per day)
- Subject is a current smoker or quit less than 3 years from screening visit
- History of substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consulting Services
High Point, North Carolina, 27262
About this study
Official title: A Single-center, Placebo Controlled Study to Investigate the Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults
Consumption of dietary supplements has been found to modulate skin health. Individual ingredients such as collagen peptides, lutein and ceramides have been shown to improve skin health. Collagen peptides have been shown to clinically improve skin texture, decrease area of skin ultraviolet damage, increase skin hydration, and improve visible skin results such as hydration, elasticity, wrinkles and roughness. Lutein has been demonstrated to increase skin radiance, protect skin from ultraviolet light, and increase skin hydration. Ceramides derived from wheat have been shown to improve skin texture, increase skin hydration and improve visible skin attributes such as hydration, elasticity, and wrinkles. This study will have subjects consuming a nutritional supplement or placebo daily for 90 days to see if there is an effect on skin health. This study will also have the subjects using a facial cleansing device, which has been shown to improve skin health, on half of their face to determine if there is a synergistic effect between dietary supplement and cleansing device. It is believed, this mixture of collagen peptides, lutein and ceramides has not been studied and the study sponsor hypothesize that this blend of ingredients will have a positive impact on skin health.
Read the detailed description
Visit 1 Screening (day -30 to -1): Subjects will be given a copy of the informed consent document. They will be given ample time to read and formulate questions prior to reviewing the document with study staff. The consent form will be reviewed with the subject and questions will be answered. The subject will provide written consent prior to starting any study related assessments. The study staff will collect the following information during this visit:
- Review medical history
- Review concomitant medications
- Measure height, weight, BMI, heart rate, blood pressure
- Review inclusion/exclusion criteria
If the subject meets inclusion/exclusion criteria they will complete the following study assessments.
- Skin examination
- Investigator facial clinical grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Digital photo of face
Visit 2 Baseline (day 0): Subjects will return to the research site for baseline visit approximately 30 days after their screening visit. Subjects will undergo assessments to determine that they continue to meet inclusion/exclusion criteria. Subjects who are eligible will be enrolled into the study and assigned a randomization number and study product. The following assessments will be completed during this visit:
- Measure weight, BMI, heart rate, blood pressure
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- 10ml Blood draw (Chemistry and CBC)
- Digital photo of face
- UV Radiation of buttocks (1MED, 2MED, 3MED)
Visit 3 Baseline + 24hrs (day 1): Subjects will return to the research site approximately 24hrs after their baseline visit. The following assessments will be completed during this visit:
- Digital photograph of irradiated buttock site
- Dermospectrophotometer of irradiated site
- Dispense 2 months of assigned study product
- Dispense skin cleansing machine and provide instruction on daily use to the right half of their face only
Visit 4 (day 30 +5 days): Subjects will return at approximately 30 days after their baseline visit. Unused study product will be collected and compliance will be calculated. The following assessments will be completed:
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Adverse events will be collected by asking if the subject has experienced any changes in their health
- Return unused study product and dispense enough assigned study product to make it through next study visit
Visit 5 (day 60 +5 days): Subjects will return at approximately 60 days after their baseline visit. Unused study product will be collected and compliance will be calculated. The following assessments will be completed:
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Adverse events will be collected by asking if the subject has experienced any changes in their health
- Return unused study product and dispense enough assigned study product to make it through next study visit
Visit 6 (day 90 +5 days): Subjects will return at approximately 90 days after their baseline visit. Unused study product will be collected and compliance will be calculated. The following assessments will be completed:
- Measure weight, BMI, heart rate, blood pressure
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- 10ml Blood draw (Chemistry and CBC)
- Digital photo of face
- UV Radiation of buttocks (1MED, 2MED, 3MED)
- Collect skin cleansing machine
- Adverse events will be collected by asking if the subject has experienced any changes in their health
Visit 7 (24 hours after visit 6): Subjects will return to the research site approximately 24hrs after visit 6. The following assessments will be completed during this visit:
- Digital photograph of irradiated buttock site
- Dermospectrophotometer of irradiated site
- Conditions
- Skin Health
- Being tested
- Beauty From Within, Placebo, Facial cleansing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beauty From WithinDietary supplement
one scoop of product mixed in 8-16 ounces of water consumed once daily
PlaceboOther
one scoop of product mixed in 8-16 ounces of water consumed once daily
Facial cleansingOther
All subjects will use a cosmetic instrument to clean on one half of their face daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo & facial cleansing | Placebo comparator | Maltodextrin and food coloring
Subjects will clean the right side of their face with a cosmetic instrument daily Receives: Other: Placebo; Other: Facial cleansing |
| Beauty From Within & facial cleansing | Active comparator | Study Product contains collagen hydrolysate, ceramide wheat extract oil and lutein
Subjects will clean the right side of their face with a cosmetic instrument daily Receives: Dietary Supplement: Beauty From Within; Other: Facial cleansing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Health (lines)
Change from baseline in investigator and subject facial grading of lines (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
Measured: baseline, day 30, day 60, and day 90
Skin Health (firmness)
Change from baseline in investigator and subject facial grading of firmness (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
Measured: baseline, day 30, day 60, and day 90
Skin Health (radiance)
Change from baseline in investigator and subject facial grading of radiance (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
Measured: baseline, day 30, day 60, and day 90
Skin Health (texture)
Change from baseline in investigator and subject facial grading of texture (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
Measured: baseline, day 30, day 60, and day 90
Skin Health (overall)
Change from baseline in investigator and subject facial grading overall (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
Measured: baseline, day 30, day 60, and day 90
Secondary outcomes (4)
Cellular protection of the skin as determined by dermospectrophotometer of UV irradiated site
Change from baseline in dermospectrophotometer at day 91 using Student T-test
Measured: baseline, and day 91
Skin elasticity of face determined by cutometer
Change from baseline in skin elasticity at days 30, 60, and 90 using Student T-test
Measured: baseline, day 30, day 60, and day 90
Ramen skin carotenoids score determined by carotenoid scan of left hand
Change from baseline in skin carotenoids at days 30, 60, and 90 using Student T-test
Measured: baseline, day 30, day 60, and day 90
Benefits of facial cleansing in concurrence with dietary supplement
Determine if facial cleansing improves outcomes over dietary supplement use alone as determined by investigator assessment using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe in lines, firmness, radiance, texture, and overall of both sides of the subjects face
Measured: baseline, day 30, day 60, and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start14 Jan 2020
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Skin HealthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, High Point NC
- Responsible party
- Sponsor
- Investigators
- Zoe D Draelos, MD, Principal investigator, Dermatology Consulting Services, High Point NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771807
- Sponsor's protocol ID
- 18-PHX-0002
- Status last verified
- Jul 2020
- First submitted
- 7 Dec 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bizot, V., E. Cestone, A. Michelotti and V. Nobile. Improving skin hydration and age-related symptoms by oral administration of wheat glucosylceramides and digalactosyl diglycerides: a human clinical study. Cosmetics 4(37): 2017
Juturu V, Bowman JP, Deshpande J. Overall skin tone and skin-lightening-improving effects with oral supplementation of lutein and zeaxanthin isomers: a double-blind, placebo-controlled clinical trial. Clin Cosmet Investig Dermatol. 2016 Oct 7;9:325-332. doi: 10.2147/CCID.S115519. eCollection 2016.
PubMed 27785083Morganti P, Fabrizi G, Bruno C. Protective effects of oral antioxidants on skin and eye function. Skinmed. 2004 Nov-Dec;3(6):310-6. doi: 10.1111/j.1540-9740.2004.02420.x.
PubMed 15538079Palombo P, Fabrizi G, Ruocco V, Ruocco E, Fluhr J, Roberts R, Morganti P. Beneficial long-term effects of combined oral/topical antioxidant treatment with the carotenoids lutein and zeaxanthin on human skin: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2007;20(4):199-210. doi: 10.1159/000101807. Epub 2007 Apr 19.
PubMed 17446716Proksch E, Schunck M, Zague V, Segger D, Degwert J, Oesser S. Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. Skin Pharmacol Physiol. 2014;27(3):113-9. doi: 10.1159/000355523. Epub 2013 Dec 24.
PubMed 24401291Proksch E, Segger D, Degwert J, Schunck M, Zague V, Oesser S. Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2014;27(1):47-55. doi: 10.1159/000351376. Epub 2013 Aug 14.
PubMed 23949208
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Placebo Controlled Study to Investigate the Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults
- ClinicalTrials.gov ID
- NCT03771807
- Acronym / sponsor ID
- 18-PHX-0002
- Conditions
- Skin Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, High Point NC
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 11 Dec 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.
Consumption of dietary supplements has been found to modulate skin health. Individual ingredients such as collagen peptides, lutein and ceramides have been shown to improve skin health. Collagen peptides have been shown to clinically improve skin texture, decrease area of skin ultraviolet damage, increase skin hydration, and improve visible skin results such as hydration, elasticity, wrinkles and roughness. Lutein has been demonstrated to increase skin radiance, protect skin from ultraviolet light, and increase skin hydration. Ceramides derived from wheat have been shown to improve skin texture, increase skin hydration and improve visible skin attributes such as hydration, elasticity, and wrinkles. This study will have subjects consuming a nutritional supplement or placebo daily for 90 days to see if there is an effect on skin health. This study will also have the subjects using a facial cleansing device, which has been shown to improve skin health, on half of their face to determine if there is a synergistic effect between dietary supplement and cleansing device. It is believed, this mixture of collagen peptides, lutein and ceramides has not been studied and the study sponsor hypothesize that this blend of ingredients will have a positive impact on skin health.
Detailed description
Visit 1 Screening (day -30 to -1): Subjects will be given a copy of the informed consent document. They will be given ample time to read and formulate questions prior to reviewing the document with study staff. The consent form will be reviewed with the subject and questions will be answered. The subject will provide written consent prior to starting any study related assessments. The study staff will collect the following information during this visit:
- Review medical history
- Review concomitant medications
- Measure height, weight, BMI, heart rate, blood pressure
- Review inclusion/exclusion criteria
If the subject meets inclusion/exclusion criteria they will complete the following study assessments.
- Skin examination
- Investigator facial clinical grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Digital photo of face
Visit 2 Baseline (day 0): Subjects will return to the research site for baseline visit approximately 30 days after their screening visit. Subjects will undergo assessments to determine that they continue to meet inclusion/exclusion criteria. Subjects who are eligible will be enrolled into the study and assigned a randomization number and study product. The following assessments will be completed during this visit:
- Measure weight, BMI, heart rate, blood pressure
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- 10ml Blood draw (Chemistry and CBC)
- Digital photo of face
- UV Radiation of buttocks (1MED, 2MED, 3MED)
Visit 3 Baseline + 24hrs (day 1): Subjects will return to the research site approximately 24hrs after their baseline visit. The following assessments will be completed during this visit:
- Digital photograph of irradiated buttock site
- Dermospectrophotometer of irradiated site
- Dispense 2 months of assigned study product
- Dispense skin cleansing machine and provide instruction on daily use to the right half of their face only
Visit 4 (day 30 +5 days): Subjects will return at approximately 30 days after their baseline visit. Unused study product will be collected and compliance will be calculated. The following assessments will be completed:
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Adverse events will be collected by asking if the subject has experienced any changes in their health
- Return unused study product and dispense enough assigned study product to make it through next study visit
Visit 5 (day 60 +5 days): Subjects will return at approximately 60 days after their baseline visit. Unused study product will be collected and compliance will be calculated. The following assessments will be completed:
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Adverse events will be collected by asking if the subject has experienced any changes in their health
- Return unused study product and dispense enough assigned study product to make it through next study visit
Visit 6 (day 90 +5 days): Subjects will return at approximately 90 days after their baseline visit. Unused study product will be collected and compliance will be calculated. The following assessments will be completed:
- Measure weight, BMI, heart rate, blood pressure
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- 10ml Blood draw (Chemistry and CBC)
- Digital photo of face
- UV Radiation of buttocks (1MED, 2MED, 3MED)
- Collect skin cleansing machine
- Adverse events will be collected by asking if the subject has experienced any changes in their health
Visit 7 (24 hours after visit 6): Subjects will return to the research site approximately 24hrs after visit 6. The following assessments will be completed during this visit:
- Digital photograph of irradiated buttock site
- Dermospectrophotometer of irradiated site
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo & facial cleansing | Placebo comparator | Other: Placebo, Other: Facial cleansingMaltodextrin and food coloring Subjects will clean the right side of their face with a cosmetic instrument daily |
| Beauty From Within & facial cleansing | Active comparator | Dietary Supplement: Beauty From Within, Other: Facial cleansingStudy Product contains collagen hydrolysate, ceramide wheat extract oil and lutein Subjects will clean the right side of their face with a cosmetic instrument daily |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males and females 40 - 60 years of age
- Individuals must present with stable moderate signs of aging that does not change between the screening visit and the baseline visit 4 weeks later
- Subject is willing and able to participate in all aspects of the study
- Individuals must sign informed consent, photo release consent and confidentiality agreement
- Subject has a BMI > 19 and < 32
Key exclusion criteria (15 listed)
- Individuals that are being treated for cancer or have a history of facial skin cancer
- Individuals with sunburn, moderate to pronounced suntan, uneven skin tones, tattoos, scares or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results
- Any disease or condition of the skin that the investigator deems inappropriate for participation, including rosacea, eczema, psoriasis, and atopic dermatitis
- Individuals currently taking medications which in the opinion of the investigator may interfere with the study. This would include but not be limited to all oral corticosteroids, use of anti-inflammatory drugs more than 14 consecutive days, immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted), hormone replacement therapy and insulin, antibiotics or other topical drugs at the test sites
- Individuals with uncontrolled metabolic diseases such as diabetes (type I and II), hypertension, hyperthyroidism or hypothyroidism, severe chronic asthma, immunological disorders such as HIV, AIDS and systemic lupus erythematosus or mastectomy for cancer involving removal of lymph nodes
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 |
|---|---|---|
| Beauty From Withinone scoop of product mixed in 8-16 ounces of water consumed once daily | Dietary supplement | Beauty From Within & facial cleansing |
| Placeboone scoop of product mixed in 8-16 ounces of water consumed once daily | Other | Placebo & facial cleansing |
| Facial cleansingAll subjects will use a cosmetic instrument to clean on one half of their face daily | Other | Beauty From Within & facial cleansing, Placebo & facial cleansing |
Primary outcome
Skin Health (lines)
Time frame: baseline, day 30, day 60, and day 90
Change from baseline in investigator and subject facial grading of lines (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
Skin Health (firmness)
Time frame: baseline, day 30, day 60, and day 90
Change from baseline in investigator and subject facial grading of firmness (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
Skin Health (radiance)
Time frame: baseline, day 30, day 60, and day 90
Change from baseline in investigator and subject facial grading of radiance (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
Skin Health (texture)
Time frame: baseline, day 30, day 60, and day 90
Change from baseline in investigator and subject facial grading of texture (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
Skin Health (overall)
Time frame: baseline, day 30, day 60, and day 90
Change from baseline in investigator and subject facial grading overall (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
4 secondary outcomes
Cellular protection of the skin as determined by dermospectrophotometer of UV irradiated site
Time frame: baseline, and day 91
Skin elasticity of face determined by cutometer
Time frame: baseline, day 30, day 60, and day 90
Ramen skin carotenoids score determined by carotenoid scan of left hand
Time frame: baseline, day 30, day 60, and day 90
Benefits of facial cleansing in concurrence with dietary supplement
Time frame: baseline, day 30, day 60, and day 90
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 9 Jul 2020.
- BackgroundBizot, V., E. Cestone, A. Michelotti and V. Nobile. Improving skin hydration and age-related symptoms by oral administration of wheat glucosylceramides and digalactosyl diglycerides: a human clinical study. Cosmetics 4(37): 2017
- Background: PubMed 27785083Juturu V, Bowman JP, Deshpande J. Overall skin tone and skin-lightening-improving effects with oral supplementation of lutein and zeaxanthin isomers: a double-blind, placebo-controlled clinical trial. Clin Cosmet Investig Dermatol. 2016 Oct 7;9:325-332. doi: 10.2147/CCID.S115519. eCollection 2016.
- Background: PubMed 15538079Morganti P, Fabrizi G, Bruno C. Protective effects of oral antioxidants on skin and eye function. Skinmed. 2004 Nov-Dec;3(6):310-6. doi: 10.1111/j.1540-9740.2004.02420.x.
- Background: PubMed 17446716Palombo P, Fabrizi G, Ruocco V, Ruocco E, Fluhr J, Roberts R, Morganti P. Beneficial long-term effects of combined oral/topical antioxidant treatment with the carotenoids lutein and zeaxanthin on human skin: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2007;20(4):199-210. doi: 10.1159/000101807. Epub 2007 Apr 19.
- Background: PubMed 24401291Proksch E, Schunck M, Zague V, Segger D, Degwert J, Oesser S. Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. Skin Pharmacol Physiol. 2014;27(3):113-9. doi: 10.1159/000355523. Epub 2013 Dec 24.
- Background: PubMed 23949208Proksch E, Segger D, Degwert J, Schunck M, Zague V, Oesser S. Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2014;27(1):47-55. doi: 10.1159/000351376. Epub 2013 Aug 14.
- 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.
Zoe D Draelos, MD principal investigator
Dermatology Consulting Services, High Point NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beauty From Within and Facial cleansing in people with Skin Health, run by Pharmanex 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 7 inclusion and 15 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 9 Jul 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?
Skin Health (lines) (time frame: baseline, day 30, day 60, and day 90). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03771807, which also lists 6 linked publications.
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 9 Jul 2020.