Breast CancerPhase 1NCT06966388
Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation
A Phase 1 study testing Azelaic Acid in people with Breast Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This pilot study will evaluate the feasibility of at least twice daily use of azelaic acid in breast cancer patients undergoing radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Azelaic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2025to 30 Nov 2027
- Phase
- Phase 1
- 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
Who may be able to join
- Age ≥ 18 years
- Self-reports as Black, Asian, Hispanic/Latin, ethnically originating from the Mediterranean rim or Pacific rim, or she/he tans easily in the sun
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 1, Section 18)
- Attestation by the patient that she/he is not pregnant, lactating, or planning to become pregnant, or planning to father a baby during the study period
- Histologic confirmation of breast malignancy (with TNM staging) If the patient did not receive adjuvant chemotherapy, adjuvant radiation must start within 180 days of lumpectomy or mastectomy. If the patient received adjuvant chemotherapy, adjuvant radiation should start within 60 days of the last dose of chemotherapy
- Treatment plan includes one of the following:
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- Conventionally fractionated whole breast radiation (45-50 Gray in 25 fractions)
- Moderately hypofractionated whole breast radiation (42.56 Gray in 16 fractions or 40 Gray in 15 fractions)
- Conventionally fractionated chest wall radiation (45-50 Gray in 25 fractions)
- Partial breast radiation (42.56 Gray in 16 fractions, 40 Gray in 15 fractions, or 30 Gray in 5 fractions) if using 3D conformal radiation or if the tumor is located close to the skin surface
- Treatment of the regional lymph nodes, a tumor bed boost (4-8 fractions), and use of tissue-equivalent bolus on the chest wall may be included at the discretion of the treating physician.
- Radiation will be photon-based. Note: If the patient receives a boost, photons and/or electrons may be used at the discretion of the treating physician.
Who cannot join
- Prior radiotherapy to any portion of the planned treatment site
- Current inflammatory breast cancer or gross dermal involvement at initiation of radiotherapy
- Concomitant immunotherapy or cytotoxic chemotherapy. Concomitant HER2 directed therapy or concomitant endocrine therapy is allowed
- Active rash or dermatitis within the treatment field, or a history of any rash or dermatologic condition within the treatment field
- Active collagen vascular diseases (ie lupus erythematosus, scleroderma, dermatomyositis)
- History of organ transplant or bone marrow transplant
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- History of hypersensitivity or allergic reaction to any ingredients in the topical azelaic acid formulation
- Has used within 28 days prior to baseline:
- topical retinoids to the breast
- oral retinoids
- systemic (oral or injectable) antibiotics known to have an impact on the severity of skin rash or sun-sensitivity (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim)
- systemic corticosteroids or immunosuppressive drugs, except as part of standard chemotherapy treatment or used for an IV contrast allergy
- Has used on treated breast within 2 weeks prior to baseline:
- topical corticosteroids
- topical antibiotics
- topical medications for skin rash (eg, metronidazole, azelaic acid)
- Radiation therapy will be proton therapy or carbon therapy
- External beam partial breast irradiation, brachytherapy partial breast irradiation, or intraoperative radiation are included in the treatment plan Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Massey CTO CPC Team, 804-628-6430, MasseyCPC@vcu.edu
Todd C. Adams, MD
About this study
Official title: Pilot Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation
This pilot study will evaluate the feasibility of at least twice daily use of azelaic acid in breast cancer patients undergoing radiation treatment.
Read the detailed description
Patients will use azelaic acid twice daily (morning and evening) beginning 1 week before radiation treatment, and will continue use until 3 weeks after completion of radiation treatment
- Conditions
- Breast Cancer
- Being tested
- Azelaic Acid
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelaic AcidDrug
A thin layer of Azelaic acid should be applied to the entire area of radiation treatment twice daily, each day of the week (including weekends) starting one week prior to the start of radiation, then during the entire course of radiation treatment (usually 3-5 weeks), and for 3 weeks following the completion of radiation treatment.
| Study group | Role | What they receive |
|---|---|---|
| Topical Azelaic Acid | Experimental | Twice daily application of azelaic acid Receives: Drug: Azelaic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of twice daily use of topical azelaic acid in patients undergoing breast radiation therapy
The percentage of days patients used azelaic acid at least once.
Measured: One week prior to radiation treatment, daily during radiation treatment up to 5 weeks, three weeks following radiation treatment
Secondary outcomes (1)
Evaluate patient-reported tolerability of topical azelaic acid
The percentage of patients that self report adverse events
Measured: Weekly during radiation treatment, and Up to three weeks following radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start13 Aug 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd C. Adams, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966388
- Sponsor's protocol ID
- MCC-23-20546
- Status last verified
- Jul 2026
- First submitted
- 2 May 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation
- ClinicalTrials.gov ID
- NCT06966388
- Acronym / sponsor ID
- MCC-23-20546
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 11 May 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.
This pilot study will evaluate the feasibility of at least twice daily use of azelaic acid in breast cancer patients undergoing radiation treatment.
Detailed description
Patients will use azelaic acid twice daily (morning and evening) beginning 1 week before radiation treatment, and will continue use until 3 weeks after completion of radiation treatment
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical Azelaic Acid | Experimental | Drug: Azelaic AcidTwice daily application of azelaic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Self-reports as Black, Asian, Hispanic/Latin, ethnically originating from the Mediterranean rim or Pacific rim, or she/he tans easily in the sun
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 1, Section 18)
- Attestation by the patient that she/he is not pregnant, lactating, or planning to become pregnant, or planning to father a baby during the study period
- Histologic confirmation of breast malignancy (with TNM staging) If the patient did not receive adjuvant chemotherapy, adjuvant radiation must start within 180 days of lumpectomy or mastectomy. If the patient received adjuvant chemotherapy, adjuvant radiation should start within 60 days of the last dose of chemotherapy
Key exclusion criteria (18 listed)
- Prior radiotherapy to any portion of the planned treatment site
- Current inflammatory breast cancer or gross dermal involvement at initiation of radiotherapy
- Concomitant immunotherapy or cytotoxic chemotherapy. Concomitant HER2 directed therapy or concomitant endocrine therapy is allowed
- Active rash or dermatitis within the treatment field, or a history of any rash or dermatologic condition within the treatment field
- Active collagen vascular diseases (ie lupus erythematosus, scleroderma, dermatomyositis)
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 |
|---|---|---|
| Azelaic AcidA thin layer of Azelaic acid should be applied to the entire area of radiation treatment twice daily, each day of the week (including weekends) starting one week prior to the start of radiation, then during the entire course of radiation treatment (usually 3-5 weeks), and for 3 weeks following the completion of radiation treatment. | Drug | Topical Azelaic Acid |
Primary outcome
Determine the feasibility of twice daily use of topical azelaic acid in patients undergoing breast radiation therapy
Time frame: One week prior to radiation treatment, daily during radiation treatment up to 5 weeks, three weeks following radiation treatment
The percentage of days patients used azelaic acid at least once.
1 secondary outcome
Evaluate patient-reported tolerability of topical azelaic acid
Time frame: Weekly during radiation treatment, and Up to three weeks following radiation 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 14 Jul 2026.
- 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.
Todd C. Adams, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azelaic Acid in people with Breast Cancer, run by Virginia Commonwealth University at 1 site in United States.
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 12 inclusion and 18 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 14 Jul 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Massey IIT Research Operations (804-628-6430, masseyepd@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the feasibility of twice daily use of topical azelaic acid in patients undergoing breast radiation therapy (time frame: One week prior to radiation treatment, daily during radiation treatment up to 5 weeks, three weeks following radiation 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 14 Jul 2026.