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OpenTrials
Completed

NCT Number: NCT05328388

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

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.

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Key information

Conditions

Skin

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Media Lab Science

Los Angeles, California, 91604, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lycomato

Dietary Supplement

Lycomato sof gels

Primary outcomes

  1. Expert clinical grading of efficacy attributes

    Time frame: 12 weeks

    Visual assessments will be performed by the expert grader using a 10-point ordinal scale on the face.

Sponsors and collaborators

Lead sponsor

LycoRed Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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