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

Dry Skin; Eczema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05048121
• Other study ID #: RCT-CLS0521
• Status: Completed
• Phase: N/A
• Start date: July 24, 2021
• Est. completion date: September 23, 2021

Study information

• Verified date: September 2021
• Source: Anbiome Labs LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 23, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Skin; Eczema
• Eczema

Intervention

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 PLC01021
Topical, face application of the cream base, two times a day in a period of 30 days

Locations

Country	Name	City	State
Bosnia and Herzegovina	Medical Department, SSST	Sarajevo
Bosnia and Herzegovina	Public Institution Sarajevo Pharmacies	Sarajevo

Sponsors (3)

Lead Sponsor	Collaborator
Anbiome Labs LLC	Public Institution Sarajevo Pharmacies, Sarajevo School of Science and Technology, Medical School Department

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Self-perceived efficacy	Self-perceived efficacy on the skin quality using Efficacy questionnaire at Week 4 as compared to baseline	4 weeks
Secondary	Sensory evaluation	Cosmetic acceptability questionnaire at Week 4	4 weeks
Secondary	Local Tolerance and Safety	Safety and Tolerance, Adverse Events Data Collection by the dermatological examiner	4 weeks