Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

29 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

16

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Grecia
    • Egaleo
      • Athens, Egaleo, Grecia, 12243
        • Panepistimioupolis Egaleo Park

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: PHASE A (4 weeks)
APPLICATION OF THE SERUM ON THE HALF SIDE OF THE FACE TWICE A DAY
Comparatore attivo: 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).
Altro: PHASE B (4 weeks)
APPLICATION OF THE CREAM ON THE HALF SIDE OF THE FACE TWICE A DAY
Comparatore placebo: 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.
Altro: PHASE A (4 weeks)
APPLICATION OF THE SERUM ON THE HALF SIDE OF THE FACE TWICE A DAY
Comparatore placebo: 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.
Altro: PHASE B (4 weeks)
APPLICATION OF THE CREAM ON THE HALF SIDE OF THE FACE TWICE A DAY
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
ELASTICITY
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

PANAGOULA PAVLOU

Investigatori

  • Direttore dello studio: ATHANASIA VARVARESOU, PROFESSOR, University of West Attica

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 gennaio 2023

Completamento primario (Effettivo)

30 maggio 2023

Completamento dello studio (Effettivo)

30 settembre 2023

Date di iscrizione allo studio

Primo inviato

22 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 3349/16-01-2023

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

All IPD that underlie results in a publication

Periodo di condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su PHASE A (4 weeks)

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Ethiopia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi