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Development and Efficacy Tests of Cannabinoid, Prebiotic, and Postbiotic-based Face Serum and Cream (CPPFC-ET)

29. april 2026 opdateret af: PANAGOULA PAVLOU

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

16

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Grækenland
    • Egaleo
      • Athens, Egaleo, Grækenland, 12243
        • Panepistimioupolis Egaleo Park

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: FACE SERUM
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.
Andet: PHASE A (4 weeks)
APPLICATION OF THE SERUM ON THE HALF SIDE OF THE FACE TWICE A DAY
Aktiv komparator: FACE CREAM
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).
Andet: PHASE B (4 weeks)
APPLICATION OF THE CREAM ON THE HALF SIDE OF THE FACE TWICE A DAY
Placebo komparator: PLACEBO SERUM
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.
Andet: PHASE A (4 weeks)
APPLICATION OF THE SERUM ON THE HALF SIDE OF THE FACE TWICE A DAY
Placebo komparator: PLACEBO CREAM
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.
Andet: PHASE B (4 weeks)
APPLICATION OF THE CREAM ON THE HALF SIDE OF THE FACE TWICE A DAY
Andet: Intermediate 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ELASTICITY
Tidsramme: 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).
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
Tidsramme: 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).
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
Tidsramme: 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.
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
Tidsramme: 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).
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

PANAGOULA PAVLOU

Efterforskere

  • Studieleder: ATHANASIA VARVARESOU, PROFESSOR, University of West Attica

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. januar 2023

Primær færdiggørelse (Faktiske)

30. maj 2023

Studieafslutning (Faktiske)

30. september 2023

Datoer for studieregistrering

Først indsendt

22. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 3349/16-01-2023

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All IPD that underlie results in a publication

IPD-delingstidsramme

Beginning right after the approval of clinical trial and ending 5 years after the publication of results

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Hydrering

Kliniske forsøg med PHASE A (4 weeks)

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