Overall Skin AppearanceNCT05048121
RCT to Evaluate the Cosmetic Efficacy of Demo-cosmetic Active Ingredient CLS02021
A study testing Cosmetic Active Ingredient CLS02021 in people with Overall Skin Appearance and Dry Skin; Eczema, run by Anbiome Labs LLC at 2 sites in Bosnia and Herzegovina.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Overall Skin Appearance, Dry Skin; Eczema
- What is being tested?
- Cosmetic Active Ingredient CLS02021
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesBosnia and Herzegovina
- Study dates
- 24 Jul 2021to 23 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Bosnia and Herzegovina2 sites
Medical Department, SSST
Sarajevo, 71000
Public Institution Sarajevo Pharmacies
Sarajevo, 71000
About this study
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
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.
- Conditions
- Overall Skin Appearance, Dry Skin; Eczema
- Being tested
- Cosmetic Active Ingredient CLS02021, Placebo PLC01021
- Keywords
- Skin Hydration, Cosmetic Appearance, Skin Health, Skin Sensitiviry
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic Active Ingredient CLS02021Other
Topical, face application of the cream base with the CLS02021, two times a day in a period of 30 days
Placebo PLC01021Other
Topical, face application of the cream base, two times a day in a period of 30 days
| Study group | Role | What they receive |
|---|---|---|
| CLS02021 - Investigational Product arm | Experimental | Cosmetic cream with proprietary cosmetic ingredient CLS02021. Receives: Other: Cosmetic Active Ingredient CLS02021 |
| PLC01021 - Placebo Control arm | Placebo comparator | Cosmetic cream, identical to the studied product but without cosmetic ingredient. Color, texture, scent and the packaging are identical as a IP. Receives: Other: Placebo PLC01021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Secondary outcomes (9)
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)
Measured: 4 weeks
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)
Measured: 4 weeks
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)
Measured: 4 weeks
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)
Measured: 4 weeks
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)
Measured: 4 weeks
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)
Measured: 4 weeks
Self-perceived efficacy
Self-perceived efficacy on the skin quality using Efficacy questionnaire at Week 4 as compared to baseline
Measured: 4 weeks
Sensory evaluation
Cosmetic acceptability questionnaire at Week 4
Measured: 4 weeks
Local Tolerance and Safety
Safety and Tolerance, Adverse Events Data Collection by the dermatological examiner
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start24 Jul 2021
- Primary completion15 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overall Skin AppearanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anbiome Labs LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Sarajevo School of Science and Technology, Medical School Department, Public Institution Sarajevo Pharmacies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048121
- Sponsor's protocol ID
- RCT-CLS0521
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05048121
- Acronym / sponsor ID
- RCT-CLS0521
- Conditions
- Overall Skin Appearance, Dry Skin; Eczema
- Keywords
- Skin Hydration, Cosmetic Appearance, Skin Health, Skin Sensitiviry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Anbiome Labs LLCUniversity, hospital or other
- Collaborators
- Sarajevo School of Science and Technology, Medical School Department, Public Institution Sarajevo Pharmacies
- Study start
- 24 Jul 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CLS02021 - Investigational Product arm | Experimental | Other: Cosmetic Active Ingredient CLS02021Cosmetic cream with proprietary cosmetic ingredient CLS02021. |
| PLC01021 - Placebo Control arm | Placebo comparator | Other: Placebo PLC01021Cosmetic cream, identical to the studied product but without cosmetic ingredient. Color, texture, scent and the packaging are identical as a IP. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic Active Ingredient CLS02021Topical, face application of the cream base with the CLS02021, two times a day in a period of 30 days | Other | CLS02021 - Investigational Product arm |
| Placebo PLC01021Topical, face application of the cream base, two times a day in a period of 30 days | Other | PLC01021 - Placebo Control arm |
Primary outcome
Moisturizing efficacy
Time frame: 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)
9 secondary outcomes
Wrinkle depth / Skin quality effect
Time frame: 4 weeks
Sebum production / Skin quality effect
Time frame: 4 weeks
Pore size / Skin quality effect
Time frame: 4 weeks
Melanin production / Skin quality effect
Time frame: 4 weeks
Sensitivity / Skin quality effect
Time frame: 4 weeks
Pore cleanliness / Skin quality effect
Time frame: 4 weeks
Self-perceived efficacy
Time frame: 4 weeks
Sensory evaluation
Time frame: 4 weeks
Local Tolerance and Safety
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic Active Ingredient CLS02021 in people with Overall Skin Appearance and Dry Skin; Eczema, run by Anbiome Labs LLC at 2 sites in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moisturizing efficacy (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.