Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults
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ClinicalTrials.gov Identifier: NCT03771807 |
Recruitment Status :
Completed
First Posted : December 11, 2018
Last Update Posted : July 9, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Skin Health | Dietary Supplement: Beauty From Within Other: Placebo Other: Facial cleansing | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | A Single-center, Placebo Controlled Study to Investigate the Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults |
Actual Study Start Date : | January 14, 2020 |
Actual Primary Completion Date : | June 20, 2020 |
Actual Study Completion Date : | June 20, 2020 |
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 |
Other: Placebo
one scoop of product mixed in 8-16 ounces of water consumed once daily Other: Facial cleansing 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 |
Dietary Supplement: Beauty From Within
one scoop of product mixed in 8-16 ounces of water consumed once daily Other: Facial cleansing All subjects will use a cosmetic instrument to clean on one half of their face daily |
- 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
- 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
- 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
- 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
- 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
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Ages Eligible for Study: | 40 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771807
United States, North Carolina | |
Dermatology Consulting Services | |
High Point, North Carolina, United States, 27262 |
Principal Investigator: | Zoe D Draelos, MD | Dermatology Consulting Services, High Point NC |
Responsible Party: | Pharmanex |
ClinicalTrials.gov Identifier: | NCT03771807 |
Other Study ID Numbers: |
18-PHX-0002 |
First Posted: | December 11, 2018 Key Record Dates |
Last Update Posted: | July 9, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |