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

NCT ID: NCT05328388

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-03-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Lycomato

Lycomato soft gel

Group Type: EXPERIMENTAL

Lycomato

Intervention Type: DIETARY_SUPPLEMENT

Lycomato sof gels

Interventions

Lycomato

Lycomato sof gels

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Females in good general health, and between ages of 35 and 55 years old, inclusive at enrollment;

2. 50 subjects: 20 Caucasians + 10 Asians + 10 African Americans + 10 Latinos;

3. All Fitzpatrick skin types being II, III and IV for Caucasian/Asian;

4. Subjects to have Glogau skin classification of photoaging, Type 2;

5. Subjects with baseline signs of facial skin aging as conformed by visual expert grading of photographs

Exclusion Criteria

1. Subjects participating in any other clinical studies;

2. Subjects that underwent beauty injections/ deep pealing/ cosmetic surgery/ tanning- for 3 months before study starts and for all the study duration.

3. 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;

4. Unreliable or unlikely to be available for the duration of the study;

5. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.;

6. Immunocompromised subjects

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

LycoRed Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Media Lab Science

Los Angeles, California, United States

Countries

United States

Other Identifiers

IRSI-E-ES-094155-01-10-21

Identifier Type: -

Identifier Source: org_study_id