An observational study in Quality of Life, Breast Neoplasms and Skin Aging, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Observational
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 50 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia is the lead sponsor of 43 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Change in Skin Hydration and Elasticity From Baseline
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.
Time frame: Before the treatment and at 4 and 24 weeks after the initial treatment
Skin quality based on investigator and subject assessments compared to baseline
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.
Time frame: At baseline, and on week 4 and 24 post study treatment
Change in Self-Esteem From Baseline
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.
Time frame: At baseline, and on week 4 and 24 post study treatment
Change in Quality of Life From Baseline
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.
Time frame: At baseline, and on week 4 and 24 post study treatment
Global Aesthetic Improvement Based on GAIS Assessment
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.
Time frame: At week 4 and 24 post study treatment
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia