Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID06966388

Pilot Study Evaluating Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation Treatment

Led by Virginia Commonwealth University · Updated on 2026-01-27

33

Participants Needed

1

Research Sites

67 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the use of topical azelaic acid applied twice daily to evaluate its feasibility in breast cancer patients undergoing radiation therapy. This pilot study focuses on patients who self-identify as Black, Asian, Hispanic/Latin, or ethnically from the Mediterranean or Pacific rim, and who tan easily. The study is conducted during the phase 1 stage, aiming to understand how well patients can use this treatment alongside their radiation schedule and to assess the treatment process.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Self-report as Black, Asian, Hispanic/Latin, or ethnically from the Mediterranean or Pacific rim, or tan easily in the sun
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Patient confirms not pregnant, lactating, or planning pregnancy/fathering during the study
  • Histologic confirmation of breast cancer with TNM staging
  • Radiation treatment plan includes specific whole breast or chest wall radiation types and doses
  • Radiation may include treatment of regional lymph nodes, tumor bed boost, and tissue-equivalent bolus as decided by physician
  • Radiation will be photon-based, with possible use of photons and/or electrons if boost given
Not Eligible

You will not qualify if you...

  • Prior radiotherapy to planned treatment site
  • Current inflammatory breast cancer or gross skin involvement at radiation start
  • Use of immunotherapy or cytotoxic chemotherapy during radiation (HER2 or endocrine therapy allowed)
  • Active rash or dermatitis in treatment area or history of such conditions there
  • Active collagen vascular diseases like lupus, scleroderma, or dermatomyositis
  • History of organ or bone marrow transplant
  • Allergy or hypersensitivity to azelaic acid ingredients
  • Use within 28 days before baseline of topical/oral retinoids, certain systemic antibiotics, systemic corticosteroids or immunosuppressants (except some chemotherapy or IV contrast allergy treatments)
  • Use within 2 weeks before baseline of topical corticosteroids, antibiotics, or skin rash medications on treated breast
  • Planned radiation is proton or carbon therapy
  • Use of external beam partial breast irradiation, brachytherapy, or intraoperative radiation
  • Medical, psychological, or social conditions that may increase risk or limit study adherence

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

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Research Team

M

Massey IIT Research Operations

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

Frequently Asked Questions

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