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

• Sponsor: Anbiome Labs LLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT05048121
• Collaborator: Sarajevo School of Science and Technology, Medical School Department (Other), Public Institution Sarajevo Pharmacies (Other)
• Enrollment: 50
• Locations: 2
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site: 25
• Patients Per Site Per Month: 12.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overall Skin Appearance; Dry Skin; Eczema	Other: Cosmetic Active Ingredient CLS02021; Other: Placebo PLC01021	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• 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.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 (Participant, Care Provider, 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.
• Primary Purpose: Supportive Care
• Official Title: 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
• Actual Study Start Date: Jul 24, 2021
• Actual Primary Completion Date: Sep 15, 2021
• Actual Study Completion Date: Sep 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CLS02021 - Investigational Product arm Cosmetic cream with proprietary cosmetic ingredient CLS02021.	Other: Cosmetic Active Ingredient CLS02021; Topical, face application of the cream base with the CLS02021, two times a day in a period of 30 days
Placebo Comparator: PLC01021 - Placebo Control arm 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; Topical, face application of the cream base, two times a day in a period of 30 days

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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)

3. 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)

4. 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)

5. 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)

6. 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)

7. Self-perceived efficacy [4 weeks]

   Self-perceived efficacy on the skin quality using Efficacy questionnaire at Week 4 as compared to baseline

8. Sensory evaluation [4 weeks]

   Cosmetic acceptability questionnaire at Week 4

9. Local Tolerance and Safety [4 weeks]

   Safety and Tolerance, Adverse Events Data Collection by the dermatological examiner

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Department, SSST	Sarajevo		Bosnia and Herzegovina	71000
2	Public Institution Sarajevo Pharmacies	Sarajevo		Bosnia and Herzegovina	71000

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anbiome Labs LLC
• ClinicalTrials.gov Identifier: NCT05048121
• Other Study ID Numbers: RCT-CLS0521
• First Posted: Sep 17, 2021
• Last Update Posted: Sep 24, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Anbiome Labs LLC: Skin Hydration; Cosmetic Appearance; Skin Health; Skin Sensitiviry
• Additional relevant MeSH terms: Eczema

Study Results

No Results Posted as of Sep 24, 2021