Condition category
Skin and Connective Tissue Diseases
Date applied
31/07/2015
Date assigned
24/08/2015
Last edited
24/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Lutein and zeaxanthin are naturally occurring compounds called carotenoids. They have both been shown to reduce the risk of cataracts and age-related macular degeneration (a condition whereby the sufferer loses their central vision, usually gradually over a period of time). Lutemax™ 2020 is a product enriched with lutein and zeaxanthin taken from Marigold flowers. This study investigates the effects of Lutemax™ 2020 (10 mg/day) when compared to a placebo for 12 weeks on the skin including lightening, hydration, roughness levels and elasticity and also to study its effects on photo damage.

Who can participate?
Adults aged 18-45 with certain skin tones and happy to follow the dietary restrictions involved.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given a dietary supplement containing carotenoids ( Lutemax™ 2020 containing 10 mg L and 2 mg Zeaxanthin isomers) or a placebo (safflower oil) taken orally (with water, after breakfast) once a day. Skin health attributes will be measured such as skin color, skin tone, hydration and elasticity are then measured for all participants in each group and compared.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
TKL Research Center, New Jersey, USA

When is the study starting and how long is it expected to run for?
March 2014 to February 2015

Who is funding the study?
OmniActive Health Technologies Inc.

Who is the main contact?
Dr Vijaya Juturu
v.juturu@omniactives.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vijaya Juturu

ORCID ID

http://orcid.org/0000-0002-7397-715X

Contact details

OmniActive Health Technologies Inc.
67 East Park Place
Suite 500
Morristown
New Jersey
07960
United States of America
18665883629307
v.juturu@omniactives.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OAHT002-2013 (CS920113)

Study information

Scientific title

The effects of oral supplementation of lutein and zeaxanthin isomers (Lutemax2020®) on skin color and skin tone: a double-blind and placebo-controlled clinical trial

Acronym

Study hypothesis

Carotenoids especially lutein and zeaxanthin isomers (RR-zeaxanthin and RS-zeaxanthin) possess absorption spectra in both in the UVB and UVA range, and are able to block the formation of melanin pathways and melanin in melanocytes, decreases inflammatory cytokines and increases anti-oxidant properties. Lutein is one of the carotenoids that is present in high concentrations in skin cells. Hence we examined the effects of lutein and zeaxanthin isomers effect on skin color and skin tone.

Ethics approval

IntegReview (USA), 03/02/2014, ref: OAHT002-2013 (TKL No. CS920113)

Study design

Randomized, double-blind, matched-pair, placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Skin health

Intervention

Lutemax2020® (containing 10 mg lutein and 2 mg zeaxanthin isomers) or a placebo (safflower oil) taken orally once a day.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Skin color
2. Skin tone
3. Photoprotective activity
4. Hydration
5. TEWL
6. Subjective assessments for skin health

Secondary outcome measures

Blood analysis such as lutein and zeaxanthin isomers

Overall trial start date

30/03/2014

Overall trial end date

15/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy, pre-menopausal females aged 18 to 45 years
2. Healthy males aged 18-45 years
3. Subjects with mild to moderate dry skin (to be determined by the Investigator).
4. Fitzpatrick Skin Type II –IV scale
5. Non-smokers
6. A body mass index (BMI) of 20 to 34 kg/m2
7. Normal values, based on the opinion of investigator, for the following assays: clinical chemistry, hematology, and urinalysis
8. Willing to avoid lutein/zeaxanthin rich foods and follow the dietary restriction list provided by the PI during the study and for 10 days prior to enrollment
9. Subjects are willing to avoid prolonged exposure to UV radiation and sun bath for the duration of the study
10. Willingness to complete all clinic visits and to complete all diaries/records associated with the study
11. Willingness to avoid cosmetics (excluding sunscreen) and cosmetic procedures (i.e., chemical peels, microdermabrasion, laser treatment) that may affect the skin on the forearms and face.
12. Willingness to use only the provided body wash and body cream for the entire 12-week study duration and to follow specific instructions related to their use on study visit days. Continued use of current facial moisturizers and cleansers will be acceptable but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid
13. Able to provide informed consent
14. Willingness not to apply regularly used make-up during each study visit

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. Subjects with moderate or severe acne.
2. Subjects who have participated in a clinical study in which they used Retin-A or a retinoid, alpha-hydroxy acids, salicylic acid or vitamin C for 3 months prior to enrollment.
3. Subjects currently using any topical medication on the face. Continued use of current facial moisturizers and cleansers will be acceptable but cannot contain alpha hydroxy acids, salicylic acid, vitamin C, retinol and retinoid.
4. History of, or current disease or condition of the skin that the investigator deems inappropriate for study participation (eg, atopic skin, acne vulgaris, facial scars, psoriasis, eczema, other scaly inflammatory diseases).
5. History of, or current diagnosis of uncontrolled chronic conditions eg liver, kidney, pulmonary, gastrointestinal, cardiovascular, pancreatic and/or immune diseases[1] (3 months on stable pharmacological treatment is acceptable).
6. History of, or current diagnosis of, cancer[1].
7. Diagnosed with hyperthyroidism or hypothyroidism[1].
8. Positive narcotics (urinalysis) or alcohol screen (breathalyzer).
9. Subjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments by a physician or skin care professional within the last 6 months from baseline or plan to have a treatment during the study.
10. Subjects using an alpha-hydroxy acid containing products within 3 months of enrollment. Continued use of current facial moisturizers and cleansers will be acceptable, but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid.
11. Subjects currently using a salicylic acid containing product on the face (including astringents and toners) 3 months prior to enrollment. Continued use of current facial moisturizers and cleansers will be acceptable but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid.
12. Subjects currently using or have used products containing retinol or retinoid on the face (including moisturizers) 3 months prior to enrollment. Continued use of current facial moisturizers and cleansers will be acceptable, but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid.
13. Subjects currently under a physician’s care for a skin problem.
14. Taking any medication that could affect skin (eg, Tetracycline).
15. Recent sunburn or having peeling due to sunburn within 2 weeks of enrollment.
16. Taking vacation involving photo exposure (beaches or skiing) during the study.
17. Subjects have used tretinoin, adapalene, tazarotene or other topical retinoid medications for the treatment of facial skin aging 3 months prior to enrollment and during the study.
18. Subjects have used or plan to use systemic corticosteroids within 30 days of enrollment or during the study.
19. Use of any dietary supplement, over-the-counter or prescription product with the indication of improving the appearance or condition of the skin (eg, antioxidants, anti-aging retinoids, antibiotics, corticosteroids) within one month of enrollment.
20. Subjects have a history of severe alcohol consumption or drug abuse in the past year (obtained through Medical History).
21. Subjects are participating in another interventional study.
22. Positive pregnancy test in women of child-bearing potential.
23. Pregnant or breast-feeding or planning on becoming pregnant.
24. Women of child-bearing potential not using effective non-hormonal contraception.
25. Use of lutein supplements or multivitamin supplements or cosmetics containing lutein or multivitamin providing more than 1 mg of lutein per day within 10 days of enrollment.

Recruitment start date

30/03/2014

Recruitment end date

30/04/2014

Locations

Countries of recruitment

United States of America

Trial participating centre

TKL Research Center
365 W Passaic St #550 Rochelle Park
New Jersey
07662
United States of America

Sponsor information

Organisation

OmniActive Health Technologies Inc

Sponsor details

67 East Park Place
Suite 500
Morristown
New Jersey
07960
United States of America
+001 8665883629307
v.juturu@omniactives.com

Sponsor type

Industry

Website

http://www.omniactives.com

Funders

Funder type

Industry

Funder name

OmniActive Health Technologies Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

30/12/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes