NCT05805735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

March 28, 2023

Last Update Submit

September 4, 2023

Conditions

AgingWrinkle

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks

    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

  • Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 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

  • +4 more secondary outcomes

Study Arms (1)

Face care product (Eye cream)

EXPERIMENTAL

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

Other: Face care product (Eye cream)

Interventions

Face care product (Eye cream)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

Face care product (Eye cream)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

proderm GmbH

Schenefeld, Germany

Location

Study Officials

  • Christiane Röck, Dipl. Biol

    SGS proderm GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Blinding of sponsor label (de-branded product)
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Intra-individual comparison
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

March 28, 2023

Primary Completion

May 30, 2023

Study Completion

August 31, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)