Clinical trial NCT05048121: RCT to Evaluate the Cosmetic Efficacy of Demo-cosmetic Active Ingredient CLS02021
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overall Skin Appearance
Dry Skin; Eczema
Keywords: Skin Hydration
Cosmetic Appearance
Skin Health
Skin Sensitiviry
Lead sponsor: Anbiome Labs LLC
Sponsor class: OTHER
Collaborators: name: Sarajevo School of Science and Technology, Medical School Department
name: Public Institution Sarajevo Pharmacies
First posted: 2021-09-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Moisturizing efficacy
timeFrame: 4 weeks
Secondary outcomes:
measure: Wrinkle depth / Skin quality effect
timeFrame: 4 weeks
measure: Sebum production / Skin quality effect
timeFrame: 4 weeks
measure: Pore size / Skin quality effect
timeFrame: 4 weeks
measure: Melanin production / Skin quality effect
timeFrame: 4 weeks
measure: Sensitivity / Skin quality effect
timeFrame: 4 weeks
measure: Pore cleanliness / Skin quality effect
timeFrame: 4 weeks
measure: Self-perceived efficacy
timeFrame: 4 weeks
measure: Sensory evaluation
timeFrame: 4 weeks
measure: Local Tolerance and Safety
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sarajevo
country: Bosnia and Herzegovina
facility: Medical Department, SSST
city: Sarajevo
country: Bosnia and Herzegovina
facility: Public Institution Sarajevo Pharmacies
Study officials:
References: