Topical Azelaic Acid for Breast Cancer Radiation
This study is looking at how practical it is for breast cancer patients to use a cream called azelaic acid twice a day while undergoing radiation therapy. The goal is to see if applying azelaic acid to the treated area twice daily, starting one week before radiation, continuing throughout treatment (usually 3-5 weeks), and for three weeks afterward, is feasible. You might be able to join if you are at least 18 years old, self-identify as Black, Asian, Hispanic/Latin, or from the Mediterranean/Pacific rim, or if you tan easily. The study is currently unclear on its recruitment status and plans to enroll 33 participants.
- Study design
- This is an interventional study, not specifying a phase, and plans to enroll 33 participants.
- What's involved
- You would apply azelaic acid cream twice daily (morning and evening) starting one week before radiation, continuing during radiation (up to 5 weeks), and for three weeks after radiation ends.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess feasibility one week prior to radiation treatment, daily during radiation treatment (up to 5 weeks), and three weeks following radiation treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06966388
Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation
Recruiting
PHASE1Ages 18+InterventionalSupportive careVirginia Commonwealth UniversityInvestigator-initiated
~33 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Azelaic Acid
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the feasibility of twice daily use of topical azelaic acid in patients undergoing breast radiation therapy
Measured over One week prior to radiation treatment, daily during radiation treatment up to 5 weeks, three weeks following radiation treatment
Conditions
Where it's being run
1 sites across 1 statesVirginia1
Study leadership
- Todd C. Adams, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
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.
Exclusion
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
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
What this trial measures
- Determine the feasibility of twice daily use of topical azelaic acid in patients undergoing breast radiation therapyOne 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.