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Clinical Study of DA-020 for the Treatment of Chemotherapy Induced Alopecia

Clinical Study of DA-020 for the Treatment of Chemotherapy Induced Alopecia

Recruiting
18-65 years
Female
Phase 1/2

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Overview

Clinical Study of DA-020 as a Treatment for Chemotherapy Induced Alopecia

Description

Chemotherapy induced alopecia (CIA) is a common adverse event of oncological treatment. The significant psychological burden of CIA, particularly in women, leads some (\~8%) to reject life saving therapeutic regimens. Several studies have demonstrated the effectiveness of scalp vasoconstriction as a prophylactic treatment for CIA. Recently, US Food and Drug Administration (FDA) approved a scalp-cooling device as a prophylactic treatment for CIA. Scalp cooling results in reduced local blood perfusion and consequently reduced chemotherapeutic agents reaching the hair follicle niche; however, scalp cooling requires prolongation of the time required to attend the chemotherapy unit (\>2 hrs) as well as common adverse events including intolerance to cold. A previous study demonstrated that the α1 agonist, phenylephrine hydrochloride, applied topically can penetrate the scalp and bind α1 receptors. As such, a topically applied α1 agonist would reduce scalp blood perfusion. A novel formula (DA-020), containing an α1 agonist, that can also penetrate the scalp and bind α1 receptors. The aim of the study is to test the hypothesis that DA-020 can reduce scalp blood perfusion and thus reduce hair loss due to chemotherapy.

Eligibility

Inclusion Criteria:

  • Diagnosed with stage I or stage II breast cancer
  • Scheduled but not begun, at least 4 cycles of taxane and/or anthracycline-based chemotherapy.
  • Ages 18-65
  • Able to give informed consent

Exclusion Criteria:

  • Resting blood pressure outside the range of 105-140/ 55-99
  • Uncontrolled or severe hypertension
  • Female pattern hair loss or hair loss disorder
  • Folliculitis
  • Scalp psoriasis
  • Seborrheic dermatitis
  • Inflammatory scalp conditions such as lichen planopillaris
  • Subjects wearing wigs prior to chemotherapy
  • Use of MAO inhibitors
  • Unable to provide consent or make allotted clinical visits

Study details
    Chemotherapy Induced Alopecia
    Chemotherapy Side Effects

NCT07397325

Applied Biology, Inc.

22 August 2026

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