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Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors (ONCO AESTHETIC)

2 novembre 2026 aggiornato da: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Improved Facial Skin Quality After Intradermal Injection of a Cross-linked 12mg/ml Hyaluronic Acid (VYC-12L) and Its Impact on Self-perception and Quality of Life in Patients With a Prior History of Breast Cancer Who Have Received and Completed Treatment With Chemotherapy and/or Systemic Monoclonal Antibodies.

Systemic treatments such as chemotherapy or monoclonal antibodies are an essential part of oncological treatment in breast cancer, which have demonstrated a survival benefit (1,2,3,4,5). This cancer is the most common cancer in women, being the cancer with the highest incidence worldwide (6), with an estimated 35,001 new cases in 2023 in Spain (7). This is why a large number of patients receive systemic treatments that help surgery and radiotherapy to achieve a cure of over 80% in our environment, with a 5-year overall survival of 85.5% having been described (7).

These systemic oncological treatments generate well-known skin alterations such as xerosis, pruritus, erythema, pigmentation alterations, papulo-pustular eruptions, dermatosis, and others such as psoriasis (8,9,10,11).

The multimodal treatment of cancer finally becomes a long and hard process which, added to the fear of the diagnosis itself, and the physical changes as a consequence of these treatments, end up reducing the state of mind of the patients who suffer from it (12,13,14).

Self-care and the aesthetic improvement of the patient's appearance are the main reasons for this.

There are aesthetic treatments, such as hyaluronic acid 12mg/ml cross-linked (VYC-12L) in intradermal injection, that could improve the quality and aesthetics of the facial skin, which could help to improve the self-perception of patients who receive it, helping them to recover their self-confidence and improve their quality of life.

Research Question:

To objectively compare the skin quality of patients with previous history of breast cancer who have received and completed treatment with chemotherapy and/or monoclonal antibodies, before and after intradermal injection a cross-linked hyaluronic acid 12mg/ml (VYC-12L) in addition to self-esteem and quality of life.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

50

Contatti e Sedi

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

Contatto studio

Luoghi di studio

  • Spagna
    • Murcia
      • Murcia, Murcia, Spagna, 30120
        • Reclutamento
        • Ctra.Madrid-Cartagena, s/n, El Palmar
        • Contatto:

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients with previous clinical history of having received and completed oncological treatment with chemotherapy and/or systemic monoclonal antibodies for breast cancer in the previous 1-18 months will be included.

Descrizione

Inclusion Criteria:

  • Patients over 18 years old of age.
  • Patients with a previous clinical history of having had breast cancer, who have received treatment and finished with chemotherapy and/or systemic monoclonal antibodies between the previous 1-18 months.
  • Patients who have received and completed treatment with neoadjuvant or adjuvant chemotherapy and/or monoclonal antibodies to breast cancer surgery between 1-18 months prior to recruitment.
  • Patients who, in the physician's opinion, can understand and properly answer study questionnaires.
  • Patients to whom participation in this study was offered and they voluntarily decided to join and signed the informed consent.

Exclusion Criteria:

  • Patients suffering from untreated epilepsy.
  • Patients with a tendency to develop hypertrophic scars.
  • Patients with known hypersensitivity to hyaluronic acid and/or gram-positive bacterial proteins since hyaluronic acid is produced by Streptococcus type bacteria.
  • Patients with known hypersensitivity to lidocaine or amide-type local anesthetics.
  • Patients suffering from porphyria.
  • Pregnant or lactating women.
  • Patients presenting inflammatory and/or infectious processes (acne, herpes, etc.).
  • Patients should not be subjected to laser treatments, deep chemical peels or dermabrasion during the duration of the study.
  • Patients with no history of psychiatric illnesses derived from the oncologic diagnosis such as confirmed major depression.

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

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Intervention

intradermal injection
Altro: Intradermal injection

12mg/ml cross-linked hyaluronic acid (VYC-12L) will be applied, distributed in 1 to 2 ml per side of the face in intradermal injection.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Skin Hydration and Elasticity From Baseline
Lasso di tempo: Before the treatment and at 4 and 24 weeks after the initial treatment

To assess the improvement compared to baseline on the hydration and elasticity using a Multidermascope Microcaya MDS 1000 skin analyzer device. Scale of 0 to 99, higher scores mean a better outcome.
Before the treatment and at 4 and 24 weeks after the initial treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Skin quality based on investigator and subject assessments compared to baseline
Lasso di tempo: At baseline, and on week 4 and 24 post study treatment

To assess the aesthetic improvement on skin quality based on investigator and subject assessments compared to baseline through an analysis with the VISIA device with 2D and 3D images at baseline using the FACE-Q Aesthetics - Psychological Function Scale . Scale of 0 to 100, higher scores mean a better outcome.
At baseline, and on week 4 and 24 post study treatment
Change in Self-Esteem From Baseline
Lasso di tempo: At baseline, and on week 4 and 24 post study treatment

To assess the overall improvement on self-esteem based on subjects assessments using the Rosemberg questionnaire (Rosenberg Self - Esteem Scale) at baseline. Scale of 0 to 40, higher scores mean a better outcome.
At baseline, and on week 4 and 24 post study treatment
Change in Quality of Life From Baseline
Lasso di tempo: At baseline, and on week 4 and 24 post study treatment

To assess the overall improvement on the quality of life based on subjects assessments using the EORTC QLQ-BR23 questionnaire quality of life specific to this patient population. Scale of 0 to 100, higher scores mean a better outcome.
At baseline, and on week 4 and 24 post study treatment
Global Aesthetic Improvement Based on GAIS Assessment
Lasso di tempo: At week 4 and 24 post study treatment

To assess an overall aesthetic improvement based on investigator and subject assessments of at least a one-point improvement on the Global Aesthetic Improvement Scale (GAIS). Scale of 1 to 5, higher scores mean a worse outcome.
At week 4 and 24 post study treatment

Collaboratori e investigatori

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

Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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)

23 ottobre 2026

Completamento primario (Stimato)

1 ottobre 2027

Completamento dello studio (Stimato)

1 ottobre 2028

Date di iscrizione allo studio

Primo inviato

22 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 novembre 2026

Primo Inserito (Effettivo)

4 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2023-11-6-HCUVA

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 .

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