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

Anbiome Labs

Status: Completed

Conditions: Dry Skin; Eczema; Overall Skin Appearance

Treatments: Other: Cosmetic Active Ingredient CLS02021; Other: Placebo PLC01021

Study type: Interventional

Funder types: Other

Identifiers

NCT05048121

RCT-CLS0521

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

CLS02021 - Investigational Product arm

Experimental group

Description:

Cosmetic cream with proprietary cosmetic ingredient CLS02021.

Treatment:

Other: Cosmetic Active Ingredient CLS02021

PLC01021 - Placebo Control arm

Placebo Comparator group

Description:

Cosmetic cream, identical to the studied product but without cosmetic ingredient. Color, texture, scent and the packaging are identical as a IP.

Treatment:

Other: Placebo PLC01021