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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05473832
Other study ID # 22.0229-39
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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