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

2. November 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

50

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Spanien
    • Murcia
      • Murcia, Murcia, Spanien, 30120
        • Rekrutierung
        • Ctra.Madrid-Cartagena, s/n, El Palmar
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Intervention

intradermal injection
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Skin Hydration and Elasticity From Baseline
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Skin quality based on investigator and subject assessments compared to baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2027

Studienabschluss (Geschätzt)

1. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

22. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. November 2026

Zuerst gepostet (Tatsächlich)

4. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2023-11-6-HCUVA

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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