RCT to Evaluate the Cosmetic Efficacy of Demo-cosmetic Active Ingredient CLS02021
NCT ID: NCT05048121
Last Updated: 2021-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2021-07-24
2021-09-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
QUADRUPLE
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.
Study Groups
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CLS02021 - Investigational Product arm
Cosmetic cream with proprietary cosmetic ingredient CLS02021.
Cosmetic Active Ingredient CLS02021
Topical, face application of the cream base with the CLS02021, two times a day in a period of 30 days
PLC01021 - Placebo Control arm
Cosmetic cream, identical to the studied product but without cosmetic ingredient. Color, texture, scent and the packaging are identical as a IP.
Placebo PLC01021
Topical, face application of the cream base, two times a day in a period of 30 days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Subjects who have given and signed written informed consent
3. Subjects who are willing to comply with the study requirements
Exclusion Criteria
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
18 Years
69 Years
ALL
Yes
Sponsors
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Sarajevo School of Science and Technology, Medical School Department
UNKNOWN
Public Institution Sarajevo Pharmacies
UNKNOWN
Anbiome Labs LLC
OTHER
Responsible Party
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Locations
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Medical Department, SSST
Sarajevo, , Bosnia and Herzegovina
Public Institution Sarajevo Pharmacies
Sarajevo, , Bosnia and Herzegovina
Countries
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Other Identifiers
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RCT-CLS0521
Identifier Type: -
Identifier Source: org_study_id
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