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| Name | Class |
|---|---|
| Sarajevo School of Science and Technology, Medical School Department | UNKNOWN |
| Public Institution Sarajevo Pharmacies | UNKNOWN |
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This study will explore the potential of probiotic based, novel cosmetic active ingredient to rebuild the collagen based skin barrier with the overall aim to rejuvenate ageing or damaged skin, improve skin integrity, appearance, beauty, and support personal well-being and vitality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLS02021 - Investigational Product arm | Experimental | Cosmetic cream with proprietary cosmetic ingredient CLS02021. |
|
| PLC01021 - Placebo Control arm | Placebo Comparator | Cosmetic cream, identical to the studied product but without cosmetic ingredient. Color, texture, scent and the packaging are identical as a IP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic Active Ingredient CLS02021 | Other | Topical, face application of the cream base with the CLS02021, two times a day in a period of 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Moisturizing efficacy | Change in Instrument measured hydration and elasticity using corneometry (Bioelectrical Impedance Analysis) on the face from baseline to Week 4 (performed by dermatological examiner-blinded) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle depth / Skin quality effect | Change in Instrument measured Skin wrinkle depth by photometry (shadow method and picture processing) on the face from baseline to Week 4 (performed by dermatological examiner-blinded) | 4 weeks |
| Sebum production / Skin quality effect |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Department, SSST | Sarajevo | 71000 | Bosnia and Herzegovina | |||
| Public Institution Sarajevo Pharmacies |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 7, 2022 | |
| Reset | Mar 17, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 7, 2022 | Mar 17, 2023 |
| ID | Term |
|---|---|
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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Infra-subject comparisons study. As the study is intraindividual, every subject will apply study product on the one side of the face and placebo on the other side of the face at the same time. Subject will not be aware what product is the study product and application is indicated only by the side of the face products are applied.
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Randomized, double blind, placebo controlled. All products will be packed in the identical packaging and will be labeled in accordance to randomization technique.
Label will contain: 4 digit, randomization code of the sample and visible sign "LEFT" or "RIGHT".
Visible sign ''Left'' or ''Right'' will indicate the side of the face the product will be applied.
| Placebo PLC01021 | Other | Topical, face application of the cream base, two times a day in a period of 30 days |
|
Change in Instrument measured Skin greasiness by photometry (sebum production/secretion) on the face from baseline to Week 4 (performed by dermatological examiner-blinded) |
| 4 weeks |
| Pore size / Skin quality effect | Change in Instrument measured Skin pore size by photometry (polarized light and picture processing) on the face from baseline to Week 4 (performed by dermatological examiner-blinded) | 4 weeks |
| Melanin production / Skin quality effect | Change in Instrument measured Skin melanin production by photometry (light absorption) on the face from baseline to Week 4 (performed by dermatological examiner-blinded) | 4 weeks |
| Sensitivity / Skin quality effect | Change in Instrument measured Skin sensitivity by photometry (light reflection) on the face from baseline to Week 4 (performed by dermatological examiner-blinded) | 4 weeks |
| Pore cleanliness / Skin quality effect | Change in Instrument measured Pore cleanliness by photometry (polarized light and picture processing) on the face from baseline to Week 4 (performed by dermatological examiner-blinded) | 4 weeks |
| Self-perceived efficacy | Self-perceived efficacy on the skin quality using Efficacy questionnaire at Week 4 as compared to baseline | 4 weeks |
| Sensory evaluation | Cosmetic acceptability questionnaire at Week 4 | 4 weeks |
| Local Tolerance and Safety | Safety and Tolerance, Adverse Events Data Collection by the dermatological examiner | 4 weeks |
| Sarajevo |
| 71000 |
| Bosnia and Herzegovina |