RCT to Evaluate the Cosmetic Efficacy of Demo-cosmetic Active Ingredient CLS02021

Study Overview
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Brief Summary
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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.

Official Title
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Multicentric, Randomized, Placebo Controlled, Intra-subject, Double Blind Study to Evaluate the Moisturizing Efficacy of a Dermo-cosmetic Product (CLS02021) Versus a Standard Moisturizer During a 4-week Application Period in Healthy Subjects

Conditions
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Overall Skin Appearance, Dry Skin; Eczema

Intervention / Treatment
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* Other: Cosmetic Active Ingredient CLS02021
* Other: Placebo PLC01021


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and/or female subjects aged 18 to 69 years Subjects who have given and signed written informed consent Subjects who are willing to comply with the study requirements Exclusion Criteria: Subjects with any systemic disorder or face dermatoses including acne that would in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, or psoriasis) Subjects with a condition or receiving a medication and/or with a history of medical/surgical events which, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study Subjects with a history of skin cancer Subjects who have started, stopped or changed of hormonal treatment (contraception, thyroid …) in the 3 months prior the study inclusion Subjects who are sensitive to any compound in the base cream Subjects who are sensitive to any active cosmetic compound including Sphingomielinaze, Hylauronic Acid, Lactic Acid or Lipothecoic acid Subjects who have used systemic drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 4 weeks prior to study inclusion Subjects who have used topical drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 4 weeks prior to study inclusion Subjects who have used scrub, anti-seborrheic topical cosmetic products and/or who have applied self-tanning products on face in the 1 week prior the study inclusion Subjects having applied any topical products on face (including make- up) the day of the study inclusion Subjects who have planned a major surgery during the study requiring hospitalization under general anesthesia and the use of systemic or topical drugs (e.g. antibiotics, anti-inflammatory) for more than 1 week Subjects belonging to the staff of the study center Subjects in an exclusion period or participating in another biomedical research study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLS02021 - Investigational Product arm<br>Cosmetic cream with proprietary cosmetic ingredient CLS02021. | Other: Cosmetic Active Ingredient CLS02021<br>* Topical, face application of the cream base with the CLS02021, two times a day in a period of 30 days<br>|
| Placebo Comparator: PLC01021 - Placebo Control arm<br>Cosmetic cream, identical to the studied product but without cosmetic ingredient. Color, texture, scent and the packaging are identical as a IP. | Other: Placebo PLC01021<br>* Topical, face application of the cream base, two times a day in a period of 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Hydration, Cosmetic Appearance, Skin Health, Skin Sensitiviry