Evaluation of the Anti-aging Efficacy of a Novel Skin Health Product
NCT ID: NCT05300984
Last Updated: 2023-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2022-03-15
2022-05-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Anti-aging Efficacy of Four Skin Health Products
NCT05473832
Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product
NCT06619457
Anti-Wrinkle Efficacy Study of an Eye-Cream
NCT05805735
Proof of Concept Anti-ageing Clinical Study in Healthy Subjects
NCT03180645
Efficacy of Four Topical Products to Improve Skin Longevity
NCT07118943
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Topical Placebo Cream
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Topical Cream with 0.5% Active
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Group 2
Topical Placebo Cream
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Topical Cream with 1% Active
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Topical Placebo Cream
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Topical Cream with 0.5% Active
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Topical Cream with 1% Active
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Willingness to actively participate in the study and to come to the scheduled visits
* Female
* From 50 to 75 years of age
* Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
* Healthy skin in the test areas
* Vaccination of tetanus within the last 10 years (for biopsy sub group)
Exclusion Criteria
* 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
* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
* Diabetes mellitus (type 1 and 2)
* One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
* Documented allergies to cosmetic products and/or ingredients, skin care and/or skin cleansing products
* Intolerability against adhesive dressing (e.g. acrylate)
* Active skin disease at the test area
* Regular use of tanning beds
* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
* Any topical medication at the test area within the last 3 days prior to the start 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
* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
* Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like paracetamol within the last 3 days prior to the start of the study
* Therapy with antibiotics within the last 2 weeks prior to the start of the study
* 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
* Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
* History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)
50 Years
75 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
proDERM GmbH
INDUSTRY
Amazentis SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD
Role: STUDY_CHAIR
proDERM GmbH
Dr. rer. nat. Sabrina Laing, MD
Role: PRINCIPAL_INVESTIGATOR
proDERM GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
proderm GmbH
Schenefeld, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22.0052-23
Identifier Type: OTHER
Identifier Source: secondary_id
22.01.AMZ
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.