Healthy Skin
Conditions
Brief summary
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.
Interventions
OTHERCosmetic product application - forearm
The cosmetic product will be applied twice daily for two weeks to the volar forearm test area.
OTHERDHA 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)
OTHERNo DHA stain
On day 1, the volar forearm test area will not undergo DHA staining.
OTHERNo cosmetic product application - forearm
The cosmetic product will not be applied for two weeks to the volar forearm test area.
OTHERCosmetic 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.
Sponsors
SGS proderm GmbH
Amazentis SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
On each volar forearm two test areas (each sized 3 cm x 3 cm) will be defined. Test area 1 will denote the lower right, 2 the upper right forearm. Test areas 3 and 4 on left forearm will be allocated accordingly. Each forearm test area will undergo one of four treatments (stained or unstained with DHA; and treated or untreated with cosmetic product) so all four treatments are experienced by every participant. Overall, the four treatment conditions (one treatment per test area) will be: 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin cell regeneration quantified by change in skin color measured by Chromameter (unit of measure: Individual Typological Angle; ITA°) | 14 days | Skin cell regeneration is quantified by the change in skin colour. Skin colour is measured with the Chromameter instrument (skin colour unit of measure: Individual Typological Angle \[ITA°\]). Therefore, skin cell regeneration is measured by the change in ITA°, such that a larger positive change in ITA° represents improved skin cell regeneration. Skin cell regeneration will be calculated 4, 8, 11, and 14 days after baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin hydration | 14 days | Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 14 days. |
| Skin barrier function | 14 days | Change from baseline in skin barrier function (assessed on Transepidermal water loss (TEWL) by Tewameter \[g/(m²h)\]) after 14 days. |
| Product traits | 14 days | Subjective evaluation of product traits assessed via questionnaire after 14 days. Product traits will be assessed by the subjects with a list of closed questions with the following predefined identical options to tick:-2 = Fully disagree; -1 = Rather disagree; 1 = Rather agree; 2 = Fully agree |
Countries
Germany
Outcome results
None listed