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

NCT07565922 | Completed

• 1 other identifier: 3349/16-01-2023
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Anti-Aging; Hydration

Keywords

face cream; cannabinoids; prebiotics; post-biotics; efficacy test; face serum

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (4)

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.

Other: PHASE A (4 weeks)

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).

Other: PHASE B (4 weeks)

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.

Other: PHASE A (4 weeks)

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.

Other: PHASE B (4 weeks); Other: Intermediate phase

Interventions

PHASE A (4 weeks) OTHER

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

FACE SERUM; PLACEBO SERUM

PHASE B (4 weeks) OTHER

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

FACE CREAM; PLACEBO CREAM

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.

PLACEBO CREAM

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy volunteers over 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• PANAGOULA PAVLOU: lead

Study Sites (1)

Panepistimioupolis Egaleo Park

Athens, Egaleo, 12243, Greece

Location

Study Officials

• ATHANASIA VARVARESOU, PROFESSOR

  University of West Attica

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ACADEMIC SCHOLAR OF THE UNIVERSITY OF WEST ATTICA

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 4, 2026
• Study Start: January 16, 2023
• Primary Completion: May 30, 2023
• Study Completion: September 30, 2023
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning right after the approval of clinical trial and ending 5 years after the publication of results

Locations

GR (1)