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

November 2, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Murcia
      • Murcia, Murcia, Spain, 30120
        • Recruiting
        • Ctra.Madrid-Cartagena, s/n, El Palmar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention

intradermal injection
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Skin Hydration and Elasticity From Baseline
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin quality based on investigator and subject assessments compared to baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

October 22, 2026

First Submitted That Met QC Criteria

November 2, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-11-6-HCUVA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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