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

LycoRed

Status: Completed

Conditions: Skin

Treatments: Dietary Supplement: Lycomato

Study type: Interventional

Funder types: Industry

Identifiers

NCT05328388

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

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 35 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Lycomato

Experimental group

Description:

Lycomato soft gel

Treatment:

Dietary Supplement: Lycomato