- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05328388
A Study to Evaluate the Effect of Lycomato on Skin Attributes in Healthy Participants.
July 21, 2022 updated by: LycoRed Ltd.
A 12-week Clinical Study to Evaluate the Efficacy of Oral Lycomato Supplement on Skin Health and Appearance 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 91604
- Media Lab Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lycomato
Lycomato soft gel
|
Lycomato sof gels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2022
Primary Completion (ACTUAL)
March 15, 2022
Study Completion (ACTUAL)
March 15, 2022
Study Registration Dates
First Submitted
April 7, 2022
First Submitted That Met QC Criteria
April 7, 2022
First Posted (ACTUAL)
April 14, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 25, 2022
Last Update Submitted That Met QC Criteria
July 21, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRSI-E-ES-094155-01-10-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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