Anti-aging Efficacy of Food Supplement and Cosmetic Routine | NCT06932770

NCT06932770

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
SGS proderm GmbH	UNKNOWN

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Skin barrier function	Change from baseline in skin barrier function (assessed onTransepidermal water loss (TEWL) by Tewameter [g/(m²h)]) after 6 and 12 weeks	12 weeks
Skin hydration	Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 6 and 12 weeks

Eligibility Module

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