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

Completed · Not applicable · Has a placebo group

Conditions studied: Skin Health

In brief

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.

Key facts

Study ID

NCT03771807

Run by

Pharmanex

People needed

60

Starts

2020-01-14

Expected to finish

2020-06-20

Last updated by the study team

2020-07-09

Who can join

Age: 40 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Dermatology Consulting Services — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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