Skip to main content
OpenTrials
Completed

NCT Number: NCT05473832

Evaluation of the Anti-aging Efficacy of Four Skin Health Products

The purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four different cosmetic products compared to an untreated control (split-face study design)

Completed

Looking for future studies?

Notify Me

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
  • From 40 to 65 years of age
  • BMI < 30 kg/m2
  • Healthy skin in the test areas
  • Uniform skin color and no erythema or dark pigmentation in the test area
  • Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
  • Ethnicity: at least one Black, Asian and Hispanic subject per study group

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
  • Active skin disease at the test area
  • Documented allergies to face/eye care products
  • Diabetes mellitus
  • 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
  • Epilepsy
  • Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation
  • Sun-tanned skin (important for the subgroup of subjects planned for Raman measurements)
  • Regular use of tanning beds
  • Any topical medication at the test area within the last 7 days prior to the start of the study
  • 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
  • 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 and/or throughout the entire course 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

Day Cream cosmetic product compared to untreated side

Other

Applied once daily in the morning

Night cream cosmetic product compared to untreated side

Other

Applied once daily in the evening

Eye cream cosmetic product compared to untreated side

Other

Applied twice daily in the morning and in the evening around the eye area

Serum cosmetic product compared to untreated side

Other

Applied twice daily in the morning and in the evening

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. Change from baseline in ceramides by Raman Spectroscopy [a.u.] on a subgroup of n=12 subjects per test product group after 2, 4 and 8 weeks

    Time frame: 8-weeks

  6. Change in Image grading (Photodocumentation via USR-Clip) for skin radiance (3 trained graders will rank each pair of images in a blinded fashion) after 2, 4 and 8 weeks

    Time frame: 8-weeks

  7. Change in wrinkle scores (Photodocumentation via USR-Clip) for anti-wrinkle efficacy (3 trained graders will rank each pair of images at the area of the crow feet's in a blinded manner)

    Time frame: 8-weeks

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

    Time frame: 8-weeks

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • proDERM GmbH

Registry information

Official study title

Evaluation of the Anti-aging Efficacy of Four Cosmetic Products

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2022
Registry last updated
Apr 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.

Published trials that share one or more normalized conditions with this study.