Skin Cell Regeneration Efficacy of Cosmetic Product (Exfoliator)

Amazentis

Status: Completed

Conditions: Healthy Skin

Treatments: Other: No cosmetic product application - forearm; Other: Cosmetic product application - forearm; Other: No DHA stain; Other: DHA stain; Other: Cosmetic products application - face

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07096466

25.0055-25

Details and patient eligibility

About

The objective of the study is to investigate the effect of one cosmetic product (exfoliator) containing Mitopure on the skin cell regeneration as well as on the skin hydration and skin barrier function in comparison to an untreated control area on the volar forearms.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 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 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

• 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
• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Untreated, stained forearm

Experimental group

Description:

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.

Treatment:

Other: DHA stain

Other: No cosmetic product application - forearm

Treated, stained forearm

Experimental group

Description:

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.

Treatment:

Other: DHA stain

Other: Cosmetic product application - forearm

Untreated, unstained forearm

Experimental group

Description:

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.

Treatment:

Other: No DHA stain

Other: No cosmetic product application - forearm

Treated, unstained forearm

Experimental group

Description:

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.

Treatment:

Other: No DHA stain

Other: Cosmetic product application - forearm

Facial treatment

Experimental group

Description:

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.

Treatment:

Other: Cosmetic products application - face