Anti-Aging, Hydration
Conditions
Keywords
face cream, cannabinoids, prebiotics, post-biotics, efficacy test, face serum
Brief summary
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.
Detailed description
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.
Interventions
OTHERPHASE A (4 weeks)
APPLICATION OF THE SERUM ON THE HALF SIDE OF THE FACE TWICE A DAY
OTHERPHASE B (4 weeks)
APPLICATION OF THE CREAM ON THE HALF SIDE OF THE FACE TWICE A DAY
OTHERIntermediate phase
THIS IS THE INTERMEDIATE PHASE BETWEEN PHASE A AND PHASE B, WHERE ALL VOLUTEERS APPLY THE PLACEBO CREAM ON BOTH SIDES OF THE FACE.
Sponsors
PANAGOULA PAVLOU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1\. Healthy volunteers over 18 years old
Exclusion criteria
1. Pregnant women 2. Individuals who were currently taking hormonal therapy 3. Individuals who were currently taking medications that cause photosensitivity 4. Individuals with active lesions of any dermatological condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ELASTICITY | 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 elasticity was measured using the Cutometer 575 (Courage + Khazaka Electronic GmbH, Cologne, Germany). |
| HYDRATION | 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. | Stratun Corneum hydration was measured using the Corneometer ® CM 825 (Courage + Khazaka Electronic GmbH, Cologne, Germany). |
| SKIN MICROTOPOGRAPHY | 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. | The Skin Visioscan VC 98 (Courage + Khazaka Electronic GmbH, Cologne, Germany) was used to visualize the skin microtopography using a UVA camera. |
| TRANSEPIDERMAL WATER LOSS | 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 was measured using the MPA 5 TEWAMETER (Courage + Khazaka Electronic GmbH, Cologne, Germany). |
Countries
Greece
Contacts
STUDY_DIRECTORATHANASIA VARVARESOU, PROFESSOR
University of West Attica
Outcome results
None listed