Anti-Wrinkle Efficacy Study of an Eye-Cream

Not Applicable

Completed

• Conditions: Wrinkle; Aging
• Interventions: Other: Face care product (Eye cream)

• Registration Number: NCT05805735
• Lead Sponsor: Amazentis SA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-28
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-04-10
• Primary Completion: 2023-05-30
• Study Completion: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Face care product (Eye cream)	Face care product (Eye cream)	Comparison between assessment times. Assessments will be performed before, after 2, 4 and 8 weeks of product application.

Primary Outcome Measures

Name	Time	Method
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).	8-weeks

Secondary Outcome Measures

Name	Time	Method
Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks	8-weeks
Assessment of eye area puffiness by photo ranking by 3 trained graders	8-weeks
Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks	8-weeks
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks	8-weeks
Dark circles color in difference by ColorFace image analysis Clinical assessment of dark circle reduction around the eye area by trained grader	8-weeks
Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks	8-weeks
Clinical assessment of dark circle reduction by trained grader	8-weeks
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks	8-weeks
Photo documentation of skin by ColorFace	8-weeks

Trial Locations

Locations (1)

proderm GmbH; 🇩🇪 Schenefeld, Germany