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

Amazentis

Status

Completed

Conditions

Skin Aging

Treatments

Other: Topical Cream with 1% Active

Other: Topical Cream with 0.5% Active

Other: Topical Placebo Cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT05300984

22.01.AMZ

22.0052-23 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

Female

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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)