Anti-aging Efficacy of Food Supplement and Cosmetic Routine (In&Out)

Amazentis

Status: Active, not recruiting

Conditions: Aging; Wrinkle

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

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06932770

25.0036-23

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

72 participants in 4 patient groups, including a placebo group

Food supplement and cosmetic routine

Experimental group

Description:

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

Treatment:

Dietary Supplement: Food Supplement active

Other: Skin care product active

Food supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Food Supplement active

Other: Skin care product placebo

Cosmetic routine

Experimental group

Description:

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

Treatment:

Dietary Supplement: Food supplement placebo

Other: Skin care product active

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Food supplement placebo

Other: Skin care product placebo