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

Not Applicable

Completed

• Conditions: Dry Skin; Eczema; Overall Skin Appearance
• Interventions: Other: Placebo PLC01021; Other: Cosmetic Active Ingredient CLS02021

• Registration Number: NCT05048121
• Lead Sponsor: Anbiome Labs LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-24
• Study First Submitted: 2021-08-27
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-09
• Primary Completion: 2021-09-15
• Study First Posted: 2021-09-17
• Study Completion: 2021-09-23
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PLC01021 - Placebo Control arm	Placebo PLC01021	Cosmetic cream, identical to the studied product but without cosmetic ingredient. Color, texture, scent and the packaging are identical as a IP.
CLS02021 - Investigational Product arm	Cosmetic Active Ingredient CLS02021	Cosmetic cream with proprietary cosmetic ingredient CLS02021.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Self-perceived efficacy	4 weeks	Self-perceived efficacy on the skin quality using Efficacy questionnaire at Week 4 as compared to baseline
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)
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)
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)
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)
Local Tolerance and Safety	4 weeks	Safety and Tolerance, Adverse Events Data Collection by the dermatological examiner
Sensory evaluation	4 weeks	Cosmetic acceptability questionnaire at Week 4

Trial Locations

Locations (2)

Medical Department, SSST; 🇧🇦 Sarajevo, Bosnia and Herzegovina

Public Institution Sarajevo Pharmacies; 🇧🇦 Sarajevo, Bosnia and Herzegovina