Anti-aging Efficacy of Food Supplement and Cosmetic Routine
NCT ID: NCT06932770
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2025-04-23
2025-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Food supplement and cosmetic routine
The "food supplement and cosmetic routine" arm will consume the food supplement active and apply the skin care product active.
Food Supplement active
The food supplement active (2 soft gels) will be consumed once per day with a large glass of water.
Skin care product active
The cosmetic skin care product active will be applied twice daily to half of the face and to one volar forearm.
Food supplement
The "food supplement" arm will consume the food supplement active and apply the skin care product placebo.
Food Supplement active
The food supplement active (2 soft gels) will be consumed once per day with a large glass of water.
Skin care product placebo
The cosmetic skin care product placebo will be applied twice daily to half of the face and to one volar forearm.
Cosmetic routine
The "cosmetic routine" arm will consume the food supplement placebo and apply the skin care product active.
Food supplement placebo
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water.
Skin care product active
The cosmetic skin care product active will be applied twice daily to half of the face and to one volar forearm.
Placebo
The "placebo" arm will consume the food supplement placebo and apply the skin care product placebo.
Food supplement placebo
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water.
Skin care product placebo
The cosmetic skin care product placebo will be applied twice daily to half of the face and to one volar forearm.
Interventions
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Food Supplement active
The food supplement active (2 soft gels) will be consumed once per day with a large glass of water.
Food supplement placebo
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water.
Skin care product active
The cosmetic skin care product active will be applied twice daily to half of the face and to one volar forearm.
Skin care product placebo
The cosmetic skin care product placebo will be applied twice daily to half of the face and to one volar forearm.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
70 Years
FEMALE
Yes
Sponsors
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SGS proderm GmbH
UNKNOWN
Amazentis SA
INDUSTRY
Responsible Party
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Principal Investigators
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Katrin Unbereit
Role: PRINCIPAL_INVESTIGATOR
SGS proderm GmbH
Locations
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SGS proderm GmbH
Schenefeld, City state of Hamburg, Germany
Countries
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Other Identifiers
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25.0036-23
Identifier Type: -
Identifier Source: org_study_id
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