Anti-aging Efficacy of Food Supplement and Cosmetic Routine

NCT06932770 | Completed

• 1 other identifier: 25.0036-23
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Aging; Wrinkle

Outcome Measures

Primary Outcomes (1)

• Anti-wrinkle efficacy

  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).

  12 weeks

Secondary Outcomes (7)

• Skin barrier function

  12 weeks

• Skin hydration

  12 weeks

• Skin firmness

  12 weeks

• Skin elasticity

  12 weeks

• Wrinkles and fine lines

  12 weeks

Study Arms (4)

Food supplement and cosmetic routine

EXPERIMENTAL

The "food supplement and cosmetic routine" arm will consume the food supplement active and apply the skin care product active.

Dietary Supplement: Food Supplement active; Other: Skin care product active

Food supplement

EXPERIMENTAL

The "food supplement" arm will consume the food supplement active and apply the skin care product placebo.

Dietary Supplement: Food Supplement active; Other: Skin care product placebo

Cosmetic routine

EXPERIMENTAL

The "cosmetic routine" arm will consume the food supplement placebo and apply the skin care product active.

Dietary Supplement: Food supplement placebo; Other: Skin care product active

Placebo

PLACEBO COMPARATOR

The "placebo" arm will consume the food supplement placebo and apply the skin care product placebo.

Dietary Supplement: Food supplement placebo; Other: Skin care product placebo

Interventions

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; Food supplement and cosmetic routine

Food supplement placebo DIETARY_SUPPLEMENT

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

Cosmetic routine; Placebo

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.

Cosmetic routine; Food supplement and cosmetic routine

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.

Food supplement; Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Amazentis SA: lead
• SGS proderm GmbH: collaborator

Study Sites (1)

SGS proderm GmbH

Schenefeld, Hamburg, 22869, Germany

Location

Study Officials

• Katrin Unbereit

  SGS proderm GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: April 23, 2025
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)