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The study includes the evaluation of efficacy of face serum/cream in healthy volunteers aged 25-60 years with the following methods: a) self-assessment questionnaire b) biophysical organological measurements of skin elasticity, skin microtopography, transepidermal water loss and stratum corneum hydration.
This study aimed to develop and evaluate a face serum and a face cream incorporating Cannabis extract, a prebiotic mixture containing Glycerin, Lactitol, Xylitol, and heat-treated Lactobacillus plantarum HEAL19, a non-viable probiotic (post-biotic) that retains structural components and functional benefits. Efficacy was evaluated through a randomized, placebo-controlled study involving sixteen healthy female volunteers aged 24-53. Each participant applied the active serum to one half of the face and a placebo one to the other, twice daily for 4 weeks (phase 1). This was followed by a 4-week period during which a placebo cream was used by all volunteers. Subsequently, each volunteer applied the active cream to one half of the face and a placebo one to the other, twice daily for 4 weeks (phase 2). Assessments included transepidermal water loss, skin microtopography, elasticity, and hydration, alongside self-assessment questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FACE SERUM | Active Comparator | Face serum with active components (cannabinoids, prebiotics, post-biotics) was applied twice a day on the half side of the face for 4 weeks (phase 1). This was followed by a 4-week period during which a placebo cream was used. |
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| FACE CREAM | Active Comparator | Face cream with active components (cannabinoids, prebiotics, post-biotics) was applied twice a day on the half side of the face for 4 weeks (phase 2). |
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| PLACEBO SERUM | Placebo Comparator | Placebo serum without active components (cannabinoids, prebiotics, post-biotics) was applied twice a day on the half side of the face for 4 weeks (phase 1). This was followed by a 4-week period during which a placebo cream was used. |
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| PLACEBO CREAM | Placebo Comparator | Placebo cream without active components (cannabinoids, prebiotics, post-biotics) was applied for 4-week period after phase 1 to all volunteers. Then it was used during the second phase of the trial (4 weeks) on the half side of the face. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHASE A (4 weeks) | Other | APPLICATION OF THE SERUM ON THE HALF SIDE OF THE FACE TWICE A DAY |
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| Measure | Description | Time Frame |
|---|---|---|
| ELASTICITY | Skin elasticity was measured using the Cutometer 575 (Courage + Khazaka Electronic GmbH, Cologne, Germany). | Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage. |
| HYDRATION | Stratun Corneum hydration was measured using the Corneometer ® CM 825 (Courage + Khazaka Electronic GmbH, Cologne, Germany). | Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage. |
| SKIN MICROTOPOGRAPHY | The Skin Visioscan VC 98 (Courage + Khazaka Electronic GmbH, Cologne, Germany) was used to visualize the skin microtopography using a UVA camera. | Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage. |
| TRANSEPIDERMAL WATER LOSS | Transepidermal water loss was measured using the MPA 5 TEWAMETER (Courage + Khazaka Electronic GmbH, Cologne, Germany). | Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage. |
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Inclusion Criteria:
1. Healthy volunteers over 18 years old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ATHANASIA VARVARESOU, PROFESSOR | University of West Attica | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panepistimioupolis Egaleo Park | Athens | Egaleo | 12243 | Greece |
All IPD that underlie results in a publication
Beginning right after the approval of clinical trial and ending 5 years after the publication of results
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| PHASE B (4 weeks) | Other | APPLICATION OF THE CREAM ON THE HALF SIDE OF THE FACE TWICE A DAY |
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| Intermediate phase | Other | THIS IS THE INTERMEDIATE PHASE BETWEEN PHASE A AND PHASE B, WHERE ALL VOLUTEERS APPLY THE PLACEBO CREAM ON BOTH SIDES OF THE FACE. |
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