Skin MicrobiomePhase 3NCT07066280
Modulating the Skin Microbiome to Prevent Radiation Dermatitis in Breast Cancer
A Phase 3 study testing Skin Repairing Cream in people with Skin Microbiome and Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Acute radiation dermatitis (ARD) is the most common treatment-related adverse reaction following radiotherapy after modified radical mastectomy and/or prosthetic breast reconstruction in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Skin Microbiome, Breast Cancer, Radiation Dermatitis
- What is being tested?
- Skin Repairing Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to Jun 2026
- Phase
- Phase 3
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and <70 years, with pathologically confirmed breast cancer;
- TNM stage T1-3N1-3M0 or T3-4N0M0;
- Underwent mastectomy with or without implant reconstruction; ④ Medically fit for adjuvant radiotherapy (i.e., in good general condition to tolerate expected side effects such as fatigue, nausea, or vomiting); ⑤ No concurrent use of other skincare products throughout the study period;
- Voluntary participation with signed informed consent, agreeing to comply with investigator-directed use of the trial product.
Who cannot join
- Prior history of radiotherapy;
- Severe systemic diseases (e.g., significant cardiac, hepatic, or renal dysfunction; immunocompromising conditions such as lymphoma, acquired immunodeficiency syndrome [AIDS], or Wiskott-Aldrich syndrome) or history of other malignancies; ③ Skin reactions due to systemic therapies (e.g., chemotherapy, immunotherapy) or active dermatologic conditions in the treatment area;
- Known hypersensitivity to the natural weak-acid macromolecular/small molecular repair cream or any of its components; ⑤ Current participation in other clinical trials or participation within the past 3 months, or judged by investigators to have poor compliance that would prevent completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong
Chen Dr, +8617620002635, 576503385@qq.com
About this study
Official title: Skin Repairing Cream for the Prevention of Radiation Dermatitis and Regulation of Skin Microbial Environment in Breast Cancer: A Multicenter, Prospective, Randomized Controlled Study
Acute radiation dermatitis (ARD) is the most common treatment-related adverse reaction following radiotherapy after modified radical mastectomy and/or prosthetic breast reconstruction in breast cancer patients. Moderate-to-severe ARD may compromise cosmetic outcomes and quality of life, and even impair radiotherapy efficacy. Current pharmacological prophylactic measures clinically employed - including topical corticosteroids, superoxide dismutase, and trolamine cream - demonstrate suboptimal efficacy and lack high-level evidence-based medical support. Emerging research indicates an association between cutaneous microbial homeostasis and ARD development, suggesting that maintaining skin surface acidity and modulating microecological balance may represent more effective preventive strategies.
This study evaluates the efficacy and safety of a natural weak-acid macromolecular/small molecular repair cream in preventing ARD among post-operative breast cancer patients receiving radiotherapy through skin microbiome modulation. We enrolled 326 high-risk early-stage breast cancer patients scheduled for post-operative radiotherapy and randomized them to compare the superiority of the natural weak-acid repair cream versus conventional care with moisturizer. Concurrent skin microbiome sampling was performed to assess microecological changes and their impact on ARD development. The findings will provide high-level clinical evidence and theoretical basis for the safer and more effective application of this natural weak-acid repair cream in preventing post-radiotherapy ARD in breast cancer patients.
- Conditions
- Skin Microbiome, Breast Cancer, Radiation Dermatitis
- Being tested
- Skin Repairing Cream, Cetaphil® Moisturizing Cream as Inactive Control
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Repairing CreamDrug
Skin Repairing Cream containing natural weak-acid
Cetaphil® Moisturizing Cream as Inactive ControlOther
Cetaphil® Moisturizing Cream
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Skin Repairing Cream |
| Control group | Other | Not described Receives: Other: Cetaphil® Moisturizing Cream as Inactive Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute radiation dermatitis (ARD) of grade 2-5
Measured: Before RT and within two weeks of completion of RT
Secondary outcomes (1)
quality of life (QoL)
Quality of Life assessment using the Skindex-16 questionnaire.
Measured: Before RT and within two weeks of completion of RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start10 Apr 2025
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin MicrobiomeStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066280
- Sponsor's protocol ID
- SYSKY-2024-1129-01
- Status last verified
- Mar 2025
- First submitted
- 4 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Repairing Cream for the Prevention of Radiation Dermatitis and Regulation of Skin Microbial Environment in Breast Cancer: A Multicenter, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07066280
- Acronym / sponsor ID
- SYSKY-2024-1129-01
- Conditions
- Skin Microbiome, Breast Cancer, Radiation Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Jul 2025 (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.
Acute radiation dermatitis (ARD) is the most common treatment-related adverse reaction following radiotherapy after modified radical mastectomy and/or prosthetic breast reconstruction in breast cancer patients. Moderate-to-severe ARD may compromise cosmetic outcomes and quality of life, and even impair radiotherapy efficacy. Current pharmacological prophylactic measures clinically employed - including topical corticosteroids, superoxide dismutase, and trolamine cream - demonstrate suboptimal efficacy and lack high-level evidence-based medical support. Emerging research indicates an association between cutaneous microbial homeostasis and ARD development, suggesting that maintaining skin surface acidity and modulating microecological balance may represent more effective preventive strategies.
This study evaluates the efficacy and safety of a natural weak-acid macromolecular/small molecular repair cream in preventing ARD among post-operative breast cancer patients receiving radiotherapy through skin microbiome modulation. We enrolled 326 high-risk early-stage breast cancer patients scheduled for post-operative radiotherapy and randomized them to compare the superiority of the natural weak-acid repair cream versus conventional care with moisturizer. Concurrent skin microbiome sampling was performed to assess microecological changes and their impact on ARD development. The findings will provide high-level clinical evidence and theoretical basis for the safer and more effective application of this natural weak-acid repair cream in preventing post-radiotherapy ARD in breast cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Skin Repairing Cream |
| Control group | Other | Other: Cetaphil® Moisturizing Cream as Inactive Control |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 and <70 years, with pathologically confirmed breast cancer;
Key exclusion criteria (3 listed)
- Prior history of radiotherapy;
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 |
|---|---|---|
| Skin Repairing CreamSkin Repairing Cream containing natural weak-acid | Drug | Experimental group |
| Cetaphil® Moisturizing Cream as Inactive ControlCetaphil® Moisturizing Cream | Other | Control group |
Primary outcome
Incidence of acute radiation dermatitis (ARD) of grade 2-5
Time frame: Before RT and within two weeks of completion of RT
1 secondary outcome
quality of life (QoL)
Time frame: Before RT and within two weeks of completion of RT
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 15 Jul 2025.
- Individual participant dataSharing planned: No
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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?
A Phase 3 study testing Skin Repairing Cream in people with Skin Microbiome and Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 4 inclusion and 3 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 15 Jul 2025. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chen Dr (17620002635, 576503385@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute radiation dermatitis (ARD) of grade 2-5 (time frame: Before RT and within two weeks of completion of RT). 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 15 Jul 2025.