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

Skin Clinical Trial

Official title:

A 12-week Clinical Study to Evaluate the Efficacy of Oral Lycomato Supplement on Skin Health and Appearance in Healthy Participants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05328388
• Other study ID #: IRSI-E-ES-094155-01-10-21
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: March 15, 2022

Study information

• Verified date: July 2022
• Source: LycoRed Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin

Intervention

Dietary Supplement:
• Lycomato
Lycomato sof gels

Locations

Country	Name	City	State
United States	Media Lab Science	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
LycoRed Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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