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Completed

NCT Number: NCT05805735

Anti-Wrinkle Efficacy Study of an Eye-Cream

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.

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

proderm GmbH

Schenefeld, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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).

    Time frame: 8-weeks

Secondary outcomes

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

    Time frame: 8-weeks

  2. Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks

    Time frame: 8-weeks

  3. Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks

    Time frame: 8-weeks

  4. Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks

    Time frame: 8-weeks

  5. Dark circles color in difference by ColorFace image analysis Clinical assessment of dark circle reduction around the eye area by trained grader

    Time frame: 8-weeks

  6. Clinical assessment of dark circle reduction by trained grader

    Time frame: 8-weeks

  7. Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks

    Time frame: 8-weeks

  8. Assessment of eye area puffiness by photo ranking by 3 trained graders

    Time frame: 8-weeks

  9. Photo documentation of skin by ColorFace

    Time frame: 8-weeks

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • proDERM GmbH

Registry information

Official study title

Anti-Wrinkle Efficacy Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2023
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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