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

NCT03771807 | Completed

• 1 other identifier: 18-PHX-0002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Health

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  baseline, day 30, day 60, and day 90

Secondary Outcomes (4)

• Cellular protection of the skin as determined by dermospectrophotometer of UV irradiated site

  baseline, and day 91

• Skin elasticity of face determined by cutometer

  baseline, day 30, day 60, and day 90

• Ramen skin carotenoids score determined by carotenoid scan of left hand

  baseline, day 30, day 60, and day 90

• Benefits of facial cleansing in concurrence with dietary supplement

  baseline, day 30, day 60, and day 90

Study Arms (2)

Placebo & facial cleansing

PLACEBO COMPARATOR

Maltodextrin and food coloring Subjects will clean the right side of their face with a cosmetic instrument daily

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

Dietary Supplement: Beauty From Within; Other: Facial cleansing

Interventions

Beauty From Within DIETARY_SUPPLEMENT

one scoop of product mixed in 8-16 ounces of water consumed once daily

Beauty From Within & facial cleansing

Placebo OTHER

one scoop of product mixed in 8-16 ounces of water consumed once daily

Placebo & facial cleansing

Facial cleansing OTHER

All subjects will use a cosmetic instrument to clean on one half of their face daily

Beauty From Within & facial cleansing; Placebo & facial cleansing

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanex: lead
• Dermatology Consulting Services, High Point NC: collaborator

Study Sites (1)

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Related Publications (6)

• 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

  BACKGROUND

• 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.

  PMID: 27785083 BACKGROUND

• 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.

  PMID: 15538079 BACKGROUND

• 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.

  PMID: 17446716 BACKGROUND

• 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.

  PMID: 24401291 BACKGROUND

• 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.

  PMID: 23949208 BACKGROUND

Study Officials

• Zoe D Draelos, MD

  Dermatology Consulting Services, High Point NC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 11, 2018
• Study Start: January 14, 2020
• Primary Completion: June 20, 2020
• Study Completion: June 20, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)