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

Skin Aging Clinical Trial

Official title:

Evaluation of the Anti-aging Efficacy of a Novel Cosmetic Product

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05300984
• Other study ID #: 22.01.AMZ
• Secondary ID: 22.0052-23
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: May 16, 2022

Study information

• Verified date: April 2023
• Source: Amazentis SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 16, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Skin Aging

Intervention

Other:
• Topical Placebo Cream
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
• Topical Cream with 0.5% Active
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
• Topical Cream with 1% Active
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design

Locations

Country	Name	City	State
Germany	proderm GmbH	Schenefeld

Sponsors (2)

Lead Sponsor	Collaborator
Amazentis SA	proDERM GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks		8 weeks
Primary	Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 8-weeks		8 weeks
Secondary	Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2-weeks		2-weeks
Secondary	Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2 and 8 weeks		8 weeks
Secondary	Change from baseline in pigmentation (assessed on skin color by Spectrophotometer) after 2 and 8 weeks		8 weeks
Secondary	Change from baseline in skin firmness by Cutometer [mm] after 2 and 8 weeks		8 weeks
Secondary	Change from baseline in skin elasticity by Cutometer after 2 and 8 weeks		8 weeks
Secondary	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		8 weeks
Secondary	Change from baseline for wrinkles and fine lines (assessed on Colorface Image analysis) after 2 and 8 weeks		8 weeks
Secondary	Subjective Evaluation of product traits assessed via questionnaire after 2 and 8 weeks		2 and 8 weeks