Aging, Wrinkle Appearance
Conditions
Brief summary
The aim of this study is to investigate the impact of a topical product on skin health and aging
Interventions
OTHERSkin care product
The cosmetic skin care product will be applied twice daily to half of the face
Sponsors
Amazentis SA
SGS proderm GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Double (Outcomes Assessor)
Intervention model description
Split-face design. Subjects will be divided equally in 2 treatment groups (topical product or untreated). Treatments will be randomly and balanced assigned to left and right test area.
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Written Informed Consent to participate in the study * Written Informed Consent for the use of the images for marketing purposes applies to subgroup participants of study 26.0112. * Willingness to actively participate in the study and to come to the scheduled visits * Female * Male, approximately 10 to 15% with little facial hair * From 45 to 65 years of age * Healthy skin in the test areas * Visible wrinkles in the face (grade 3 to 6 according to proderm wrinkle score)
Exclusion criteria
* Female participants: Pregnancy or lactation * Drug addicts, alcoholics * AIDS, HIV-positive or infectious hepatitis * Conditions which exclude a participation or might influence the test reaction/evaluation * Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area * Active skin disease at the test area * Documented allergies to face/eye care products or their ingredients * Diabetes mellitus * Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years * One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases * Epilepsy * Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation * Regular use of tanning beds within the last 6 weeks prior to the start of the study * Any topical medication at the test area within the last 3 days prior to the start of the study * Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study and throughout the entire course of the study that in the opinion of the investigator may affect the outcome of the study * Therapy with antibiotics within the last 2 weeks prior to the start of the study and throughout the entire course of the study that in the opinion of the investigator may affect the outcome of the study * Cosmetic surgery procedure in the test area (e.g. laser, facelift) within the last 2 years and throughout the entire course of the study * Cosmetic surgery treatments in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and throughout the entire course of the study * Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study and throughout the entire course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin hydration | 8 weeks | Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 2 and 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-wrinkle efficacy | 8 weeks | Change from baseline in anti-wrinkles efficacy (assessed on three-dimensional structure of the wrinkles in the periorbital regions) after 2 and 8 weeks. Anti-wrinkle efficacy will be assessed using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra). |
| Skin barrier function | 8 weeks | Change from baseline in skin barrier function (assessed onTransepidermal water loss (TEWL) by Tewameter \[g/(m²h)\]) after 2 and 8 weeks |
| Skin firmness | 8 weeks | Change from baseline in skin firmness (assessed by R0 (Uf) by Cutometer \[mm\]) after 2 and 8 weeks |
| Skin elasticity | 8 weeks | Change from baseline in skin elasticity (assessed by R7 (Ur/Uf) by Cutometer) after 2 and 8 weeks |
| Clinical skin appearance | 8 weeks | Change from baseline for skin appearance (assessed on VISIA-CR Image analysis) after 2 and 8 weeks |
| Skin aging hallmarks | 8 weeks | Change from baseline in skin hallmarks of aging (assessed on 22mm D-Squames® tape strips) after 2 and 8 weeks |
| Product traits | 8 weeks | Subjective evaluation of product traits assessed via questionnaire after 2 and 8 weeks. Product traits will be assessed by the subjects with a list of closed questions with the following predefined identical options to tick: 2 = Fully disagree; 1 = Rather disagree; 1. = Rather agree; 2. = Fully agree |
| Clinical Before-After Photography | 8 weeks | An additional cohort of 15 participants will apply the test product to their full face. Trained graders will analyze images (assessed on VISIA-CR Image) to visually determine biological skin age after 2 and 8 weeks. |
Countries
Germany
Outcome results
None listed