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Completed

NCT Number: NCT07565922

Development and Efficacy Tests of Cannabinoid, Prebiotic, and Postbiotic-based Face Serum and Cream

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.

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Key information

Conditions

Anti-Aging Hydration

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Panepistimioupolis Egaleo Park

Athens, Egaleo, 12243, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers over 18 years old

Exclusion criteria

  • Pregnant women
  • Individuals who were currently taking hormonal therapy
  • Individuals who were currently taking medications that cause photosensitivity
  • Individuals with active lesions of any dermatological condition

Treatment and study plan

PHASE A (4 weeks)

Other

APPLICATION OF THE SERUM ON THE HALF SIDE OF THE FACE TWICE A DAY

PHASE B (4 weeks)

Other

APPLICATION OF THE CREAM ON THE HALF SIDE OF THE FACE TWICE A DAY

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.

Primary outcomes

  1. ELASTICITY

    Time frame: 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).

  2. HYDRATION

    Time frame: 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).

  3. SKIN MICROTOPOGRAPHY

    Time frame: 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.

  4. TRANSEPIDERMAL WATER LOSS

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

PANAGOULA PAVLOU

Other

Registry information

Official study title

Study of the Effectiveness of Moisturizing/Anti-aging Cosmetic Products for External Application in Healthy Volunteers

Acronym: CPPFC-ET

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 4, 2026
Registry last updated
May 4, 2026

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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