Skin
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTLycomato
Lycomato sof gels
Sponsors
LycoRed Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expert clinical grading of efficacy attributes | 12 weeks | Visual assessments will be performed by the expert grader using a 10-point ordinal scale on the face. |
Countries
United States
Outcome results
None listed