Quality of LifeONCO AESTHETICNCT07917117
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
An observational study of Quality of Life and Breast Neoplasms, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Breast Neoplasms, Skin Aging
- What is being tested?
- Intradermal injection
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 23 Oct 2026to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Ctra.Madrid-Cartagena, s/n, El Palmar
Murcia, Murcia, 30120
Antonio J Lozano, Doctor, ES-626980234 ext. +34, antoniojlozano@live.com
About this study
Official title: 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).
Read more
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.
- Conditions
- Quality of Life, Breast Neoplasms, Skin Aging, Hyaluronic Acid
- Being tested
- Intradermal injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal injectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | intradermal injection Receives: Other: Intradermal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the treatment and at 4 and 24 weeks after the initial treatment
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At week 4 and 24 post study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start23 Oct 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917117
- Sponsor's protocol ID
- 2023-11-6-HCUVA
- Acronym
- ONCO AESTHETIC
- Status last verified
- Nov 2026
- First submitted
- 22 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07917117
- Acronym / sponsor ID
- ONCO AESTHETIC / 2023-11-6-HCUVA
- Conditions
- Quality of Life, Breast Neoplasms, Skin Aging, Hyaluronic Acid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: Intradermal injectionintradermal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal injection12mg/ml cross-linked hyaluronic acid (VYC-12L) will be applied, distributed in 1 to 2 ml per side of the face in intradermal injection. | Other | Intervention |
Primary outcome
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.
4 secondary outcomes
Skin quality based on investigator and subject assessments compared to baseline
Time frame: 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
Change in Quality of Life From Baseline
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Breast Neoplasms, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio J Lozano, Doctor (ES 626980234 ext. +34, antoniojlozano@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Hydration and Elasticity From Baseline (time frame: Before the treatment and at 4 and 24 weeks after the initial treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.