Clinical trial NCT05300984: Evaluation of the Anti-aging Efficacy of a Novel Skin Health Product
Official title: Evaluation of the Anti-aging Efficacy of a Novel Cosmetic Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Keywords: Mitochondria, Aging
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: proDERM GmbH
First posted: 2022-03-29
Enrollment: 48
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split face/arm design
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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
* 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)

Primary outcomes:
measure: Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 8-weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2-weeks
timeFrame: 2-weeks
measure: Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2 and 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in pigmentation (assessed on skin color by Spectrophotometer) after 2 and 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in skin firmness by Cutometer [mm] after 2 and 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in skin elasticity by Cutometer after 2 and 8 weeks
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
measure: Change from baseline for wrinkles and fine lines (assessed on Colorface Image analysis) after 2 and 8 weeks
timeFrame: 8 weeks
measure: Subjective Evaluation of product traits assessed via questionnaire after 2 and 8 weeks
timeFrame: 2 and 8 weeks
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: proderm GmbH
Study officials:
affiliation: proDERM GmbH
name: Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD
role: STUDY_CHAIR
affiliation: proDERM GmbH
name: Dr. rer. nat. Sabrina Laing, MD
role: PRINCIPAL_INVESTIGATOR
References: