Anti-Wrinkle Efficacy Study of an Eye-Cream

NCT ID: NCT05805735

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-28
• Study Completion Date: 2023-08-31

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.

Conditions

Aging; Wrinkle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Face care product (Eye cream)

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

Group Type: EXPERIMENTAL

Face care product (Eye cream)

Intervention Type: OTHER

The test material(s) will be cosmetic products to be applied around the eye region on both sides of the face daily. The test product will be applied twice daily in the morning and in the evening by the subjects

Interventions

Face care product (Eye cream)

The test material(s) will be cosmetic products to be applied around the eye region on both sides of the face daily. The test product will be applied twice daily in the morning and in the evening by the subjects

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

proDERM GmbH

INDUSTRY

Sponsor Role: collaborator

Amazentis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christiane Röck, Dipl. Biol

Role: PRINCIPAL_INVESTIGATOR

SGS proderm GmbH

Locations

proderm GmbH

Schenefeld, , Germany

Countries

Germany

Other Identifiers

23.0076-27

Identifier Type: -

Identifier Source: org_study_id