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

NCT05048121 | Completed DMC

• 1 other identifier: RCT-CLS0521
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Overall Skin Appearance; Dry Skin; Eczema

Keywords

Skin Hydration; Cosmetic Appearance; Skin Health; Skin Sensitiviry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Wrinkle depth / Skin quality effect

  4 weeks

• Sebum production / Skin quality effect

  4 weeks

• Pore size / Skin quality effect

  4 weeks

• Melanin production / Skin quality effect

  4 weeks

• Sensitivity / Skin quality effect

  4 weeks

Study Arms (2)

CLS02021 - Investigational Product arm

EXPERIMENTAL

Cosmetic cream with proprietary cosmetic ingredient CLS02021.

Other: Cosmetic Active 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.

Other: Placebo PLC01021

Interventions

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

CLS02021 - Investigational Product arm

Placebo PLC01021 OTHER

Topical, face application of the cream base, two times a day in a period of 30 days

PLC01021 - Placebo Control arm

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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 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

Sponsors & Collaborators

• Anbiome Labs LLC: lead
• Sarajevo School of Science and Technology, Medical School Department: collaborator
• Public Institution Sarajevo Pharmacies: collaborator

Study Sites (2)

Medical Department, SSST

Sarajevo, 71000, Bosnia and Herzegovina

Location

Public Institution Sarajevo Pharmacies

Sarajevo, 71000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 17, 2021
• Study Start: July 24, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 23, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BO (2)