Back to resultsRCT to Evaluate the Cosmetic Efficacy of Demo-cosmetic Active Ingredient CLS02021
Primary Purpose
Overall Skin Appearance, Dry Skin; Eczema
Status
Completed
Phase
Not Applicable
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
Cosmetic Active Ingredient CLS02021
Placebo PLC01021
Sponsored by
About this trial
This is an interventional supportive care trial for Overall Skin Appearance focused on measuring Skin Hydration, Cosmetic Appearance, Skin Health, Skin Sensitiviry
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 have started, stopped or changed of hormonal treatment (contraception, thyroid …) in the 3 months prior the study inclusion
- 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 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
- 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
- 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
- Subjects having applied any topical products on face (including make- up) the day of the study inclusion
- 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
- Subjects in an exclusion period or participating in another biomedical research study
Sites / Locations
- Medical Department, SSST
- Public Institution Sarajevo Pharmacies
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CLS02021 - Investigational Product arm
PLC01021 - Placebo Control arm
Arm Description
Cosmetic cream with proprietary cosmetic ingredient CLS02021.
Cosmetic cream, identical to the studied product but without cosmetic ingredient. Color, texture, scent and the packaging are identical as a IP.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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)
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)
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)
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)
Self-perceived efficacy
Self-perceived efficacy on the skin quality using Efficacy questionnaire at Week 4 as compared to baseline
Sensory evaluation
Cosmetic acceptability questionnaire at Week 4
Local Tolerance and Safety
Safety and Tolerance, Adverse Events Data Collection by the dermatological examiner
Full Information
NCT ID
NCT05048121
First Posted
August 27, 2021
Last Updated
September 23, 2021
Sponsor
Anbiome Labs LLC
Collaborators
Sarajevo School of Science and Technology, Medical School Department, Public Institution Sarajevo Pharmacies
1. Study Identification
Unique Protocol Identification Number
NCT05048121
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 24, 2021 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anbiome Labs LLC
Collaborators
Sarajevo School of Science and Technology, Medical School Department, Public Institution Sarajevo Pharmacies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overall Skin Appearance, Dry Skin; Eczema
Keywords
Skin Hydration, Cosmetic Appearance, Skin Health, Skin Sensitiviry
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLS02021 - Investigational Product arm
Arm Type
Experimental
Arm Description
Cosmetic cream with proprietary cosmetic ingredient CLS02021.
Arm Title
PLC01021 - Placebo Control arm
Arm Type
Placebo Comparator
Arm Description
Cosmetic cream, identical to the studied product but without cosmetic ingredient. Color, texture, scent and the packaging are identical as a IP.
Intervention Type
Other
Intervention Name(s)
Cosmetic Active Ingredient CLS02021
Intervention Description
Topical, face application of the cream base with the CLS02021, two times a day in a period of 30 days
Intervention Type
Other
Intervention Name(s)
Placebo PLC01021
Intervention Description
Topical, face application of the cream base, two times a day in a period of 30 days
Primary Outcome Measure Information:
Title
Moisturizing efficacy
Description
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)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Wrinkle depth / Skin quality effect
Description
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)
Time Frame
4 weeks
Title
Sebum production / Skin quality effect
Description
Change in Instrument measured Skin greasiness by photometry (sebum production/secretion) on the face from baseline to Week 4 (performed by dermatological examiner-blinded)
Time Frame
4 weeks
Title
Pore size / Skin quality effect
Description
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)
Time Frame
4 weeks
Title
Melanin production / Skin quality effect
Description
Change in Instrument measured Skin melanin production by photometry (light absorption) on the face from baseline to Week 4 (performed by dermatological examiner-blinded)
Time Frame
4 weeks
Title
Sensitivity / Skin quality effect
Description
Change in Instrument measured Skin sensitivity by photometry (light reflection) on the face from baseline to Week 4 (performed by dermatological examiner-blinded)
Time Frame
4 weeks
Title
Pore cleanliness / Skin quality effect
Description
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)
Time Frame
4 weeks
Title
Self-perceived efficacy
Description
Self-perceived efficacy on the skin quality using Efficacy questionnaire at Week 4 as compared to baseline
Time Frame
4 weeks
Title
Sensory evaluation
Description
Cosmetic acceptability questionnaire at Week 4
Time Frame
4 weeks
Title
Local Tolerance and Safety
Description
Safety and Tolerance, Adverse Events Data Collection by the dermatological examiner
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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 have started, stopped or changed of hormonal treatment (contraception, thyroid …) in the 3 months prior the study inclusion
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 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
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
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
Subjects having applied any topical products on face (including make- up) the day of the study inclusion
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
Subjects in an exclusion period or participating in another biomedical research study
Facility Information:
Facility Name
Medical Department, SSST
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Public Institution Sarajevo Pharmacies
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RCT to Evaluate the Cosmetic Efficacy of Demo-cosmetic Active Ingredient CLS02021
We'll reach out to this number within 24 hrs