Skin ageing and its effects on skin hydration, elasticity/firmness and profilometry Skin and Connective Tissue Diseases
Conditions
Interventions
A double-blind, randomized, placebo-controlled clinical study is carried out on 3 groups of 25 subjects each as follows:
G1 use placebo cosmetic product + active food supplement for 28
Sponsors
Complife Italia Srl
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Good general health 2. Females of caucasian ethnicity 3. Photoype I to IV 4. Age between 35 and 70 years old 5. Mild/moderate signs of ageing (mild/moderate Crow’s feet wrinkles and mild/moderate face slackness) 6. Subjects who have not been recently involved in any other similar study 7. Willingness to use for face care only the creams that will be consigned at the beginning of the study 8. Willingness to submit before and after pictures 9. Willingness to use during all the study period only the products to be tested 10. Willingness not to use similar products that could interfere with the product to be tested 11. Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, etc.) 12. Subject is under effective contraception (oral/not oral); not expected to be changed during the trial 13. Subject aware of the study procedures and having signed an informed consent form 14. Subjects who accept not to expose themselves in an intensive way to UV rays during the whole study duration
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Pregnant/breastfeeding female or who have planned pregnancy during the study period 3. Positive history for atopy or hypersensitive skin 4. Subjects under systemically pharmacological treatment 5. Subjects under locally pharmacological treatment on the skin area monitored during the test 6. Subjects with congenital or acquired immunodeficiency 7. Subjects under treatment with food supplements which could interfere with the functionality of the product under study 8. Subjects which show other skin alterations on the monitored area 9. Subjects considered as not adequate to participate in the study by the investigator 10. Subjects with known or suspected sensitization to one or more test formulation ingredients 11. Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated) 12. Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation or impaired brain function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Determination of the Skin moisturization, evaluated as skin moisturization index using a Corneometer® and as Gray Index using MoistureMap MM 100 at baseline and after 14, 28 and 42 days 2. Determination of skin elasticity and firmness, based on the suction/elongation method and the subsequent release of the skin using Cutometer® at baseline and after 14, 28 and 42 days 3. Determination of skin profilometry, measuring wrinkle depth and skin roughness using Primos 3D at baseline and after 14, 28 and 42 days 4. Acquisition of face digital pictures using a reflex digital camera at baseline and after 14, 28 and 42 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Products tolerability, efficacy, and acceptability evaluated using a self-assessment questionnaire administered after 4 weeks (T28), and after a 14 days wash-out from oral treatment (T42) | — |
Countries
Italy
Contacts
Public ContactFrancesco Tursi
Outcome results
None listed