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Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults

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ClinicalTrials.gov Identifier: NCT03771807
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Dermatology Consulting Services, High Point NC
Information provided by (Responsible Party):
Pharmanex

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Skin Health Dietary Supplement: Beauty From Within Other: Placebo Other: Facial cleansing Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females 40 - 60 years of age
  2. Individuals must present with stable moderate signs of aging that does not change between the screening visit and the baseline visit 4 weeks later
  3. Subject is willing and able to participate in all aspects of the study
  4. Individuals must sign informed consent, photo release consent and confidentiality agreement
  5. Subject has a BMI > 19 and < 32
  6. Subject must be on a stable dose of chronic use medications for at least 3 months prior to study participation
  7. 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:

  1. Individuals that are being treated for cancer or have a history of facial skin cancer
  2. 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
  3. Any disease or condition of the skin that the investigator deems inappropriate for participation, including rosacea, eczema, psoriasis, and atopic dermatitis
  4. 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
  5. 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
  6. Subject is taking skin, nail, and hair health promoting supplement orally (including products containing collagen and carotenoids)
  7. Women known to be pregnant, nursing, or planning to become pregnant
  8. Individuals participating in other facial clinical trials
  9. 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
  10. Individuals with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules) at the test site
  11. Individuals who have had chemical peels or dermabrasion within the last six months prior to baseline visit
  12. Individuals who have sun tanned (sun or tanning beds) in the nude within the past 1 year prior to baseline visit
  13. Excessive alcohol use (>2 drinks per day)
  14. Subject is a current smoker or quit less than 3 years from screening visit
  15. History of substance abuse

Information from the National Library of Medicine

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


Contacts
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Contact: Gayle Robertson 3368412040 skinstudy@northstate.net

Locations
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United States, North Carolina
Dermatology Consulting Services Recruiting
High Point, North Carolina, United States, 27262
Contact: Gayle Robertson    336-841-2040    skinstudy@northstate.net   
Principal Investigator: Zoe D Draelos, MD         
Sponsors and Collaborators
Pharmanex
Dermatology Consulting Services, High Point NC
Investigators
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Principal Investigator: Zoe D Draelos, MD Dermatology Consulting Services, High Point NC

Publications:
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Responsible Party: Pharmanex
ClinicalTrials.gov Identifier: NCT03771807     History of Changes
Other Study ID Numbers: 18-PHX-0002
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No