Clinical trial NCT05805735: Anti-Wrinkle Efficacy Study of an Eye-Cream
Official title: Anti-Wrinkle Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Wrinkle
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: proDERM GmbH
First posted: 2023-04-10
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intra-individual comparison
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the anti-aging and reduction of dark circles efficacy of a cosmetic product after 8 weeks of application.


Eligibility criteria: Inclusion Criteria:

* Written informed consent to participate in the study
* Willingness to actively participate in the study and to come to the scheduled visits
* Female and male (approx. 10% male)
* Between 40 and 65 years of age
* Visible wrinkles in the periorbital regions in accordance with the study site's score of at least grade 3
* Dark circles according to self-assessment (not guaranteed on darker skin types)
* Healthy skin in the test areas
* Uniform skin color and no erythema or dark pigmentation (except dark cycles are still visible) in the test area

Exclusion Criteria:

* Female subjects: 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
* 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
* Insulin-dependent diabetes mellitus
* Any topical medication at the test area within the last 7 days prior to the start of the study and/or throughout the entire course of the study
* Documented allergies to face care or cleansing products
* Active skin disease at the test area
* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
* Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
* Cosmetic surgery procedure 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
* Epilepsy
* Obesity with a BMI \> 40
* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) and/or within the last 7 days prior to the start 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

Primary outcomes:
measure: Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
timeFrame: 8-weeks
Secondary outcomes:
measure: Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks
timeFrame: 8-weeks
measure: Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks
timeFrame: 8-weeks
measure: Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks
timeFrame: 8-weeks
measure: Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks
timeFrame: 8-weeks
measure: Dark circles color in difference by ColorFace image analysis Clinical assessment of dark circle reduction around the eye area by trained grader
timeFrame: 8-weeks
measure: Clinical assessment of dark circle reduction by trained grader
timeFrame: 8-weeks
measure: Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks
timeFrame: 8-weeks
measure: Assessment of eye area puffiness by photo ranking by 3 trained graders
timeFrame: 8-weeks
measure: Photo documentation of skin by ColorFace
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: proderm GmbH
Study officials:
affiliation: SGS proderm GmbH
name: Christiane Röck, Dipl. Biol
role: PRINCIPAL_INVESTIGATOR
References: