Evaluation of the Anti-aging Efficacy of Four Skin Health Products

Skin Aging Clinical Trial

Official title:

Evaluation of the Anti-aging Efficacy of Four Cosmetic Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05473832
• Other study ID #: 22.0229-39
• Status: Completed
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: October 17, 2022

Study information

• Verified date: April 2023
• Source: Amazentis SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four different cosmetic products compared to an untreated control (split-face study design)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 17, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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 and male
• From 40 to 65 years of age
• BMI < 30 kg/m2
• Healthy skin in the test areas
• Uniform skin color and no erythema or dark pigmentation in the test area
• Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
• Ethnicity: at least one Black, Asian and Hispanic subject per study group

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
• 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
• Sun-tanned skin (important for the subgroup of subjects planned for Raman measurements)
• Regular use of tanning beds
• Any topical medication at the test area within the last 7 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
• 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

Related Conditions & MeSH terms

• Anti-Aging
• Skin Aging

Intervention

Other:
• Day Cream cosmetic product compared to untreated side
Applied once daily in the morning
• Night cream cosmetic product compared to untreated side
Applied once daily in the evening
• Eye cream cosmetic product compared to untreated side
Applied twice daily in the morning and in the evening around the eye area
• Serum cosmetic product compared to untreated side
Applied twice daily in the morning and in the evening

Locations

Country	Name	City	State
Germany	proderm GmbH	Schenefeld

Sponsors (2)

Lead Sponsor	Collaborator
Amazentis SA	proDERM GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).		8-weeks
Secondary	Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks		8-weeks
Secondary	Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks		8-weeks
Secondary	Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks		8-weeks
Secondary	Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks		8-weeks
Secondary	Change from baseline in ceramides by Raman Spectroscopy [a.u.] on a subgroup of n=12 subjects per test product group after 2, 4 and 8 weeks		8-weeks
Secondary	Change in Image grading (Photodocumentation via USR-Clip) for skin radiance (3 trained graders will rank each pair of images in a blinded fashion) after 2, 4 and 8 weeks		8-weeks
Secondary	Change in wrinkle scores (Photodocumentation via USR-Clip) for anti-wrinkle efficacy (3 trained graders will rank each pair of images at the area of the crow feet's in a blinded manner)		8-weeks
Secondary	Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks		8-weeks