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

Not Applicable

Completed

• Conditions: Skin
• Interventions: Dietary Supplement: Lycomato

• Registration Number: NCT05328388
• Lead Sponsor: LycoRed Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lycomato	Lycomato	Lycomato soft gel

Primary Outcome Measures

Name	Time	Method
Expert clinical grading of efficacy attributes	12 weeks	Visual assessments will be performed by the expert grader using a 10-point ordinal scale on the face.

Trial Locations

Locations (1)

Media Lab Science; 🇺🇸 Los Angeles, California, United States