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Completed

NCT Number: NCT05048121

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

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.

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Key information

Conditions

Overall Skin Appearance Dermatitis Dry Skin; Eczema Eczema Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Department, SSST, Sarajevo, Bosnia and Herzegovina

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cosmetic Active Ingredient CLS02021

Other

Topical, face application of the cream base with the CLS02021, two times a day in a period of 30 days

Placebo PLC01021

Other

Topical, face application of the cream base, two times a day in a period of 30 days

Primary outcomes

  1. 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)

Secondary outcomes

  1. Wrinkle depth / Skin quality effect

    Time frame: 4 weeks

    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)

  2. Sebum production / Skin quality effect

    Time frame: 4 weeks

    Change in Instrument measured Skin greasiness by photometry (sebum production/secretion) on the face from baseline to Week 4 (performed by dermatological examiner-blinded)

  3. Pore size / Skin quality effect

    Time frame: 4 weeks

    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)

  4. Melanin production / Skin quality effect

    Time frame: 4 weeks

    Change in Instrument measured Skin melanin production by photometry (light absorption) on the face from baseline to Week 4 (performed by dermatological examiner-blinded)

  5. Sensitivity / Skin quality effect

    Time frame: 4 weeks

    Change in Instrument measured Skin sensitivity by photometry (light reflection) on the face from baseline to Week 4 (performed by dermatological examiner-blinded)

  6. Pore cleanliness / Skin quality effect

    Time frame: 4 weeks

    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)

  7. Self-perceived efficacy

    Time frame: 4 weeks

    Self-perceived efficacy on the skin quality using Efficacy questionnaire at Week 4 as compared to baseline

  8. Sensory evaluation

    Time frame: 4 weeks

    Cosmetic acceptability questionnaire at Week 4

  9. Local Tolerance and Safety

    Time frame: 4 weeks

    Safety and Tolerance, Adverse Events Data Collection by the dermatological examiner

Sponsors and collaborators

Lead sponsor

Anbiome Labs LLC

Other

Collaborators

  • Public Institution Sarajevo Pharmacies
  • Sarajevo School of Science and Technology, Medical School Department

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2021
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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