Clinical trial NCT06932770: Anti-aging Efficacy of Food Supplement and Cosmetic Routine
Official title: Anti-aging Efficacy Study With Food Supplement and Cosmetic Routine vs Placebo
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aging
Wrinkle
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: SGS proderm GmbH
First posted: 2025-04-17
Enrollment: 72
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-face design. Subjects will be divided equally in 2 treatment groups (food supplement active or food supplement placebo). Group 1 will receive treatments A and B (food supplement active with cosmetic active on one volar forearm and one side of face and cosmetic placebo on the other volar forearm and side of face) and group 2 C and D (food supplement placebo with cosmetic active on one volar forearm and one side of face and cosmetic placebo on the other volar forearm and side of face). Treatments will be randomly and balanced assigned to left and right test area in each group.
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the impact of a topical and an oral product alone and in combination compared to placebo on skin aging


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 40 to 70 years of age, in order to include sufficient subjects for the study, if necessary, the age may be gradually increased to 70 years or decreased to 40 years
* Healthy skin in the test areas
* Visible wrinkles in the face (grade 3 to 6 according to proderm wrinkle score)

For biopsy subpanel:

- Vaccination of tetanus within the last 10 years

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 and food supplements or their ingredients
* Intake of dietary supplements within the last 3 months before the start of the study
* 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
* Regular use of tanning beds
* Any topical medication at the test area within the last 3 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
* Therapy with antibiotics within the last 2 weeks 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

For biopsy subpanel:

* 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
* History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)
* Known intolerance to local anaesthetics
* Known Sensitivity to any dressing systems

Primary outcomes:
measure: Anti-wrinkle efficacy
timeFrame: 12 weeks
Secondary outcomes:
measure: Skin barrier function
timeFrame: 12 weeks
measure: Skin hydration
timeFrame: 12 weeks
measure: Skin firmness
timeFrame: 12 weeks
measure: Skin elasticity
timeFrame: 12 weeks
measure: Wrinkles and fine lines
timeFrame: 12 weeks
measure: Skin aging hallmarks
timeFrame: 12 weeks
measure: Product traits
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: SGS proderm GmbH
state: Hamburg
Study officials:
affiliation: SGS proderm GmbH
name: Katrin Unbereit
role: PRINCIPAL_INVESTIGATOR
References: