Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation

NCT06966388 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MCC-23-20546
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will evaluate the feasibility of at least twice daily use of azelaic acid in breast cancer patients undergoing radiation treatment.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Weekly during radiation treatment, and Up to three weeks following radiation treatment

Study Arms (1)

Topical Azelaic Acid

EXPERIMENTAL

Twice daily application of azelaic acid

Drug: Azelaic Acid

Interventions

Azelaic Acid DRUG

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.

Topical Azelaic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

azelaic acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Todd C. Adams, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massey IIT Research Operations

CONTACT

804-628-6430; masseyepd@vcu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)