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
30 participants
INTERVENTIONAL
2025-06-23
2025-07-09
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 One Face Care Cosmetic Product
NCT06619457
Evaluation of the Anti-aging Efficacy of a Novel Skin Health Product
NCT05300984
The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Photoaging
NCT02126644
Clinical Evaluation of Day and Night Skin Care Creams Supplemented With MediCell Technology (MCT)'s Composition of Defensins and Supportive Molecules
NCT02765763
Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products
NCT03629405
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
A) Untreated with cosmetic product, stained with DHA (negative control) B) Treated with cosmetic product, stained with DHA C) Untreated with cosmetic product, unstained (negative control) D) Treated with cosmetic product, unstained
Treatments will be randomly and balanced assigned to the four volar forearm test areas.
E) All participants will also apply two cosmetic products to the facial area.
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Untreated, stained forearm
On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will not be applied for two weeks to the volar forearm test area.
DHA stain
On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours)
No cosmetic product application - forearm
The cosmetic product will not be applied for two weeks to the volar forearm test area.
Treated, stained forearm
On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area.
DHA stain
On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours)
Cosmetic product application - forearm
The cosmetic product will be applied twice daily for two weeks to the volar forearm test area.
Untreated, unstained forearm
On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will not be applied for two weeks to the volar forearm test area.
No DHA stain
On day 1, the volar forearm test area will not undergo DHA staining.
No cosmetic product application - forearm
The cosmetic product will not be applied for two weeks to the volar forearm test area.
Treated, unstained forearm
On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area.
No DHA stain
On day 1, the volar forearm test area will not undergo DHA staining.
Cosmetic product application - forearm
The cosmetic product will be applied twice daily for two weeks to the volar forearm test area.
Facial treatment
For two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily.
Cosmetic products application - face
For two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DHA stain
On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours)
No DHA stain
On day 1, the volar forearm test area will not undergo DHA staining.
Cosmetic product application - forearm
The cosmetic product will be applied twice daily for two weeks to the volar forearm test area.
No cosmetic product application - forearm
The cosmetic product will not be applied for two weeks to the volar forearm test area.
Cosmetic products application - face
For two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily.
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 and/or male
* From 18 to 65 years of age
* Healthy skin in the test area
* Uniform skin color in the test area
* Fitzpatrick I-III
* Able to read and follow directions as outlined in the protocol
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
* Insulin-dependent diabetes mellitus (type 1 and 2)
* Documented allergies to cosmetic products and/or ingredients,
* Documented allergies to plaster systems or tape adhesives
* Active skin disease at the test area like acute dermatitis, that requires actual topical medication on the test area and/or systemic drug treatment according to a physician
* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
* All kinds of beard (except a moustache) during the whole study
* Any topical medication at the test area within the last 3 days prior to the start of the study and throughout the entire course of the study
* Topical medication with anti-inflammatories, antihistamines within 1 week prior to the start of the study
* Topical medication with Immuno-suppressive medication within 2 weeks prior to the start of the study
* Systemic (oral) medication with Antibiotic (except penicillin) or anti-inflammatory steroids within 4 weeks prior to the start of the study and throughout the entire course of the study
* Systemic (oral) medication with anti-inflammatory non-steroids within 2 weeks prior to the start of the study and throughout the entire course of the study
* Phototherapy within 4 weeks prior to the start of the study and throughout the entire course of the study
* Systemic (oral) medication with retinoids within 6 months prior to the start of the study and throughout the entire course of the study
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SGS proderm GmbH
UNKNOWN
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.
Dr Katrin Unbereit
Role: PRINCIPAL_INVESTIGATOR
SGS proderm GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SGS 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.
25.0055-25
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.