Anti-Wrinkle Efficacy Study of an Eye-Cream

Amazentis

Status: Completed

Conditions: Aging; Wrinkle

Treatments: Other: Face care product (Eye cream)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05805735

23.0076-27

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

36 participants in 1 patient group

Face care product (Eye cream)

Experimental group

Description:

Comparison between assessment times. Assessments will be performed before, after 2, 4 and 8 weeks of product application.

Treatment:

Other: Face care product (Eye cream)