Dry Skin; Eczema, Overall Skin Appearance
Conditions
Keywords
Skin Hydration, Cosmetic Appearance, Skin Health, Skin Sensitiviry
Brief summary
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.
Interventions
OTHERCosmetic Active Ingredient CLS02021
Topical, face application of the cream base with the CLS02021, two times a day in a period of 30 days
OTHERPlacebo PLC01021
Topical, face application of the cream base, two times a day in a period of 30 days
Sponsors
Sarajevo School of Science and Technology, Medical School Department
Public Institution Sarajevo Pharmacies
Anbiome Labs LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and/or female subjects aged 18 to 69 years 2. Subjects who have given and signed written informed consent 3. Subjects who are willing to comply with the study requirements
Exclusion criteria
1. 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) 2. 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 3. Subjects with a history of skin cancer 4. Subjects who have started, stopped or changed of hormonal treatment (contraception, thyroid …) in the 3 months prior the study inclusion 5. Subjects who are sensitive to any compound in the base cream 6. Subjects who are sensitive to any active cosmetic compound including Sphingomielinaze, Hylauronic Acid, Lactic Acid or Lipothecoic acid 7. 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 8. 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 9. 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 10. Subjects having applied any topical products on face (including make- up) the day of the study inclusion 11. 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 12. Subjects belonging to the staff of the study center 13. Subjects in an exclusion period or participating in another biomedical research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moisturizing efficacy | 4 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sebum production / Skin quality effect | 4 weeks | Change in Instrument measured Skin greasiness by photometry (sebum production/secretion) on the face from baseline to Week 4 (performed by dermatological examiner-blinded) |
| Pore size / Skin quality effect | 4 weeks | 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) |
| Melanin production / Skin quality effect | 4 weeks | Change in Instrument measured Skin melanin production by photometry (light absorption) on the face from baseline to Week 4 (performed by dermatological examiner-blinded) |
| Sensitivity / Skin quality effect | 4 weeks | Change in Instrument measured Skin sensitivity by photometry (light reflection) on the face from baseline to Week 4 (performed by dermatological examiner-blinded) |
| Wrinkle depth / Skin quality effect | 4 weeks | 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) |
| Self-perceived efficacy | 4 weeks | Self-perceived efficacy on the skin quality using Efficacy questionnaire at Week 4 as compared to baseline |
| Sensory evaluation | 4 weeks | Cosmetic acceptability questionnaire at Week 4 |
| Local Tolerance and Safety | 4 weeks | Safety and Tolerance, Adverse Events Data Collection by the dermatological examiner |
| Pore cleanliness / Skin quality effect | 4 weeks | 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) |
Countries
Bosnia and Herzegovina
Outcome results
None listed