A Study to Evaluate the Effect of Lycomato on Skin Attributes in Healthy Participants.

NCT05328388 | Completed

• 1 other identifier: IRSI-E-ES-094155-01-10-21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be performed with oral gels, with up to 55 study subjects who meet the inclusion and non-inclusion criteria required. Study subjects will be instructed to use the products during 12 weeks and they will be assessed and supervised throughout the study by clinic technicians, in order to check for possible adverse events. Efficacy documentation through digital photography, instrumental measurements with the devices Cutometer® MPA 580 and Tewameter®, image acquisition with Visia-CA® as well as self-assessment through questionnaires will be carried out.

Conditions

Skin

Outcome Measures

Primary Outcomes (1)

• Expert clinical grading of efficacy attributes

  Visual assessments will be performed by the expert grader using a 10-point ordinal scale on the face.

  12 weeks

Study Arms (1)

Lycomato

EXPERIMENTAL

Lycomato soft gel

Dietary Supplement: Lycomato

Interventions

Lycomato DIETARY_SUPPLEMENT

Lycomato sof gels

Lycomato

Eligibility Criteria

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

You may qualify if:

• Females in good general health, and between ages of 35 and 55 years old, inclusive at enrollment;
• subjects: 20 Caucasians + 10 Asians + 10 African Americans + 10 Latinos;
• All Fitzpatrick skin types being II, III and IV for Caucasian/Asian;
• Subjects to have Glogau skin classification of photoaging, Type 2;
• Subjects with baseline signs of facial skin aging as conformed by visual expert grading of photographs

You may not qualify if:

• Subjects participating in any other clinical studies;
• Subjects that underwent beauty injections/ deep pealing/ cosmetic surgery/ tanning- for 3 months before study starts and for all the study duration.
• Subjects having an acute or chronic disease or medical condition, including dermatological problems, which could put her at risk in the opinion of the Principal Investigator or compromise study outcomes. Typical uncontrolled chronic or serious diseases and conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes (insulin dependent), renal impairment, mental illness, drug/alcohol addiction;
• Unreliable or unlikely to be available for the duration of the study;
• History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.;
• Immunocompromised subjects

Sponsors & Collaborators

• LycoRed Ltd.: lead

Study Sites (1)

Media Lab Science

Los Angeles, California, 91604, United States

Location

MeSH Terms

Interventions

Lycopene

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Design

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

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: January 1, 2022
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)