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Completed

NCT Number: NCT05300984

Evaluation of the Anti-aging Efficacy of a Novel Skin Health Product

The aim of this study is to investigate the effect of cosmetic products with two different concentrations of the active on skin aging and in acting on the mitochondrial health of skin in comparison to a placebo product.

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Key information

Conditions

Age range

50 year–75 year

Sex eligibility

Female

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
  • From 50 to 75 years of age
  • Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
  • Healthy skin in the test areas
  • Vaccination of tetanus within the last 10 years (for biopsy sub 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
  • Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
  • Diabetes mellitus (type 1 and 2)
  • One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
  • Documented allergies to cosmetic products and/or ingredients, skin care and/or skin cleansing products
  • Intolerability against adhesive dressing (e.g. acrylate)
  • Active skin disease at the test area
  • Regular use of tanning beds
  • Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
  • Any topical medication at the test area within the last 3 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
  • Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
  • Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like paracetamol within the last 3 days prior to the start of the study
  • Therapy with antibiotics within the last 2 weeks prior to the start of the study
  • Regular medication with anti-coagulating drugs like Aspirin®, Macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies
  • Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
  • History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)

Treatment and study plan

Topical Placebo Cream

Other

cosmetic cream to be applied topically on face and forearms twice/daily using split/face design

Topical Cream with 0.5% Active

Other

cosmetic cream to be applied topically on face and forearms twice/daily using split/face design

Topical Cream with 1% Active

Other

cosmetic cream to be applied topically on face and forearms twice/daily using split/face design

Primary outcomes

  1. Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks

    Time frame: 8 weeks

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

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 2-weeks

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

    Time frame: 8 weeks

  3. Change from baseline in pigmentation (assessed on skin color by Spectrophotometer) after 2 and 8 weeks

    Time frame: 8 weeks

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

  6. Change from baseline in skin layer thickness and undulation index of DEJ (assessed on Line field confocal Optical Coherence Tomography Image analysis) after 8 weeks for both groups or after 2 and 8 weeks

    Time frame: 8 weeks

  7. Change from baseline for wrinkles and fine lines (assessed on Colorface Image analysis) after 2 and 8 weeks

    Time frame: 8 weeks

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

    Time frame: 2 and 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 a Novel Cosmetic Product

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 29, 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.

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