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

Study Overview
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Brief Summary
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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.

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

Conditions
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Skin

Intervention / Treatment
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* Dietary Supplement: Lycomato


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females in good general health, and between ages of 35 and 55 years old, inclusive at enrollment; 50 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lycomato<br>Lycomato soft gel | Dietary Supplement: Lycomato<br>* Lycomato sof gels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |