- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03771807
Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults
A Single-center, Placebo Controlled Study to Investigate the Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
High Point, North Carolina, United States, 27262
- Dermatology Consulting Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo & facial cleansing
Maltodextrin and food coloring Subjects will clean the right side of their face with a cosmetic instrument daily |
one scoop of product mixed in 8-16 ounces of water consumed once daily
All subjects will use a cosmetic instrument to clean on one half of their face daily
|
Active Comparator: Beauty From Within & facial cleansing
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 |
All subjects will use a cosmetic instrument to clean on one half of their face daily
one scoop of product mixed in 8-16 ounces of water consumed once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline, day 30, day 60, and day 90
|
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
|
baseline, day 30, day 60, and day 90
|
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
|
baseline, day 30, day 60, and day 90
|
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
|
baseline, day 30, day 60, and day 90
|
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
|
baseline, day 30, day 60, and day 90
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cellular protection of the skin as determined by dermospectrophotometer of UV irradiated site
Time Frame: baseline, and day 91
|
Change from baseline in dermospectrophotometer at day 91 using Student T-test
|
baseline, and day 91
|
Skin elasticity of face determined by cutometer
Time Frame: baseline, day 30, day 60, and day 90
|
Change from baseline in skin elasticity at days 30, 60, and 90 using Student T-test
|
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
|
Change from baseline in skin carotenoids at days 30, 60, and 90 using Student T-test
|
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
|
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
|
baseline, day 30, day 60, and day 90
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zoe D Draelos, MD, Dermatology Consulting Services, High Point NC
Publications and helpful links
General 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.
- Morganti 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.
- Palombo 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.
- Proksch 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.
- Proksch 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 18-PHX-0002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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