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Completed

NCT Number: NCT06932770

Anti-aging Efficacy of Food Supplement and Cosmetic Routine

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

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Key information

Conditions

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

SGS proderm GmbH

Schenefeld, Free and Hanseatic City of Hamburg, 22869, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food Supplement active

Dietary Supplement

The food supplement active (2 soft gels) will be consumed once per day with a large glass of water.

Food supplement placebo

Dietary Supplement

The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water.

Skin care product active

Other

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

Other

The cosmetic skin care product placebo will be applied twice daily to half of the face and to one volar forearm.

Primary outcomes

  1. Anti-wrinkle efficacy

    Time frame: 12 weeks

    Change from baseline in anti-wrinkles efficacy (assessed on three-dimensional structure of the wrinkles in the periorbital regions) after 6 and 12 weeks. Anti-wrinkle efficacy will be assessed using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).

Secondary outcomes

  1. Skin barrier function

    Time frame: 12 weeks

    Change from baseline in skin barrier function (assessed onTransepidermal water loss (TEWL) by Tewameter [g/(m²h)]) after 6 and 12 weeks

  2. Skin hydration

    Time frame: 12 weeks

    Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 6 and 12 weeks

  3. Skin firmness

    Time frame: 12 weeks

    Change from baseline in skin firmness (assessed by R0 (Uf) by Cutometer [mm]) after 6 and 12 weeks

  4. Skin elasticity

    Time frame: 12 weeks

    Change from baseline in skin elasticity (assessed by R7 (Ur/Uf) by Cutometer) after 6 and 12 weeks

  5. Wrinkles and fine lines

    Time frame: 12 weeks

    Change from baseline for wrinkles and fine lines (assessed on VISIA-CR Image analysis) after 6 and 12 weeks

  6. Skin aging hallmarks

    Time frame: 12 weeks

    Change from baseline in skin hallmarks of aging (assessed on 3mm punch skin biopsies) after 12 weeks in a subpanel of participants

  7. Product traits

    Time frame: 12 weeks

    Subjective evaluation of product traits assessed via questionnaire after 6 and 12 weeks.

    Product traits will be assessed by the subjects with a list of closed questions with the following predefined identical options to tick:

    • 2 = Fully disagree;
    • 1 = Rather disagree;
    • = Rather agree;
    • = Fully agree

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • SGS proderm GmbH

Registry information

Official study title

Anti-aging Efficacy Study With Food Supplement and Cosmetic Routine vs Placebo

Acronym: In&Out

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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