A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement Lumenato and Its Impact on Skin Parameters in Healthy Female Subjects

NCT04356456 | Withdrawn

• 1 other identifier: LSDH02-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate perceived changes in skin health and appearance after taking the study product daily for 12 weeks. The study product is a soft gel supplement containing tomato oil. cored Lumenato supplement on skin health and appearance.

Conditions

Skin

Keywords

Nutritional Supplement

Outcome Measures

Primary Outcomes (1)

• VISIA-CR® images of each subject's face

  VISIA-CR® takes a series of standardized, reproducible digital facial images, inside of a controlled lighting environment. Subjects' front, left, and right views will be captured with their eyes gently closed using the following lighting parameters.

  12 weeks

Secondary Outcomes (3)

• Baseline Skin Questionnaire

  12 weeks

• End of Study Product Questionnaire"

  12 weeks

• Skin Update Questionnaire

  12 weeks

Other Outcomes (2)

• 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

Study Arms (2)

Lumenato Supplement

EXPERIMENTAL

Lumenato oleoresin

Dietary Supplement: Lumenato

Placebo

PLACEBO COMPARATOR

paraffin oil

Dietary Supplement: Lumenato

Interventions

Lumenato DIETARY_SUPPLEMENT

tomato oleoresin obtained from yellow dry tomato pulp

Lumenato Supplement; Placebo

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: 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

Study Sites (1)

Consumer product testing (CPT)

Fairfield, New Jersey, 07004, 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

• Michael Caswell, PhD

  CPT

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomization at 1:1 ratio for active or placebo

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 22, 2020
• Study Start: January 14, 2020
• Primary Completion: June 30, 2020
• Study Completion: August 8, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)