Lumenato Nutritional Supplement on Skin Appearance

NCT04248699 | Completed

• 1 other identifier: OBVIO-LYC-002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This 12-week study is an open-label study assessing the perceived effectiveness of the Lycored Lumenato supplement on skin health and appearance.

Conditions

Skin

Keywords

Nutritional Supplement

Outcome Measures

Primary Outcomes (1)

• Participant perception of the improvement in skin health and appearance from Baseline to Week 12 using the questionnaire responses from FACE-Q™

  FACE-Q™ Satisfaction with Skin scale: gathers the participant perspective of their satisfaction or dissatisfaction with their facial skin using a 12-question scale. Participants are asked to choose one of the following responses for each question: Very Dissatisfied (1), Somewhat Dissatisfied (2), Somewhat Satisfied (3) and Very Satisfied (4) for each 12 questions and the sum of scores (or mean of the completed items, in the event of an incomplete scale) gets converted into a score from 0 (worst) to 100 (best).

  12 weeks

Secondary Outcomes (3)

• Baseline Skin Questionnaire

  12 weeks

• End of Study Product Questionnaire"

  12 weeks

• Skin Update Questionnaire

  12 weeks

Other Outcomes (3)

• Adverse events (AEs) observed during the study, classified by the investigator as to severity, relationship to the study product/protocol, and seriousness

  14 weeks

• Compliance to the daily use of the Lycored Lumenato supplement through monitoring within ClaimIt (Weekly e-Diary)

  12 weeks

• Sustainability of effect after two weeks without supplementation as assessed by the Week 14 FACE-Q™ Satisfaction with Skin scale

  14 weeks

Study Arms (1)

Lumenato Supplement

EXPERIMENTAL

tomato oleoresin

Dietary Supplement: Lumenato

Interventions

Lumenato DIETARY_SUPPLEMENT

tomato oleoresin obtained from yellow dry tomato pulp

Lumenato Supplement

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Resides in the United States
• Generally healthy women between the ages of 35-55
• Fitzpatrick skin types 2 or 3
• Identifies as one of the following: Asian, White, Hispanic/Latino, or both White and Hispanic/Latino
• Type 2 on the Glogau Skin Classification scale
• Has expressed interest in improving skin health and appearance
• Willing and able to follow the procedures of the study
• Willing to refrain from changing their diet or lifestyle significantly for the duration of the study
• Able to understand the study requirements and activities in English, and provide informed consent
• Access to reliable internet service and smartphone in order to utilize the ClaimIt software/app needed to remotely participate in the study

You may not qualify if:

• Participants with Fitzpatrick skin types of 1, 4, 5 or 6
• Known allergies or sensitivity to tomato, latex and/or potato
• Current use or use within 1 month of study enrollment of hormonal therapies (including hormonal contraceptives)
• Current, regular use or regular use within 1 month of study enrollment of oral steroids; regular use defined as \>10 consecutive days
• Chronic or relapsing inflammatory and/or allergic skin conditions such as atopic dermatitis, rosacea, psoriasis and alike including telangiectasias ("spider veins")
• Pregnant, lactating or breastfeeding women (within the last 6 months) or those planning to become pregnant during the study period
• Less than 2 years since diagnosis or treatment of skin cancer including basal cell carcinoma, squamous cell carcinoma, melanoma- excluding actinic keratosis
• Currently active herpes infections or currently on treatment for herpes infections
• History of facial keloids
• Current diagnosis of adult acne or currently on treatment for adult acne
• Recent (\<6 months at enrollment) cardiovascular conditions such as stroke, transient ischemic attack (TIA), or myocardial ischemia/infarction, recently on treatment for congestive heart failure, or currently having vasculitis or vascular conditions
• On potent blood thinners such as low-molecular weight heparin (LMWH), rivaroxaban, apixaban, or other prescription blood thinners - excludes aspirin
• Holds a current diagnosis of diabetes mellitus type I or II
• Participants who have received facial irradiation within last year or are planning on undergoing facial irradiation during the study
• Chronic liver disease- excluding early stage non-alcoholic fatty liver disease (NAFLD)

Sponsors & Collaborators

• LycoRed Ltd.: lead
• ObvioHealth: collaborator

Study Sites (1)

o ObvioHealth

Orlando, Florida, 32817, United States

Location

Related Publications (4)

• Glogau RG. Aesthetic and anatomic analysis of the aging skin. Semin Cutan Med Surg. 1996 Sep;15(3):134-8. doi: 10.1016/s1085-5629(96)80003-4.

  PMID: 8948530 BACKGROUND

• Groten K, Marini A, Grether-Beck S, Jaenicke T, Ibbotson SH, Moseley H, Ferguson J, Krutmann J. Tomato Phytonutrients Balance UV Response: Results from a Double-Blind, Randomized, Placebo-Controlled Study. Skin Pharmacol Physiol. 2019;32(2):101-108. doi: 10.1159/000497104. Epub 2019 Mar 5.

  PMID: 30836363 BACKGROUND

• Havas F, Krispin S, Melendez-Martinez AJ, von Oppen-Bezalel L. Preliminary Data on the Safety of Phytoene- and Phytofluene-Rich Products for Human Use including Topical Application. J Toxicol. 2018 Apr 15;2018:5475784. doi: 10.1155/2018/5475784. eCollection 2018.

  PMID: 29849613 BACKGROUND

• Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.

  PMID: 3377516 RESULT

Study Officials

• Parth Shah, MD

  ObvioHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 30, 2020
• Study Start: January 14, 2020
• Primary Completion: June 8, 2020
• Study Completion: July 8, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)