Menu
Not yet recruiting NCT06762548

Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia

Phase III Interventional Chemotherapy Induced Alopecia Chemotherapy Side Effects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DA-007, Placebo.
Who it may be relevant to
Registry conditions: Chemotherapy Induced Alopecia, Chemotherapy Side Effects. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Clinical Study of DA-007 As a Treatment for Chemotherapy Induced Alopecia

Detailed 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-007), 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-007 can reduce scalp blood perfusion and thus reduce hair loss due to chemotherapy.

Interventions

  • Drug DA-007
    Topical α1 agonist combination of Phenylephrine + Tyramine + Synephrine
  • Drug Placebo
    Topical placebo solution

Primary outcome measures

  • Prevention of Hair Loss (Common Terminology Criteria for Adverse Events V5.0) [Time frame: Week [0,12]]
Secondary outcome measures (1)
  • Hair Re-Growth Post Treatment (Common Terminology Criteria for Adverse Events V5.0) [Time frame: Week [12, 24]]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Italy · 1 center
  • University of Rome ("G. Marconi") — Rome

Publications

  • Fahl WE. Complete prevention of radiation-induced dermatitis using topical adrenergic vasoconstrictors. Arch Dermatol Res. 2016 Dec;308(10):751-757. doi: 10.1007/s00403-016-1691-2. Epub 2016 Oct 4. PMID 27704205
  • Soref CM, Fahl WE. A new strategy to prevent chemotherapy and radiotherapy-induced alopecia using topically applied vasoconstrictor. Int J Cancer. 2015 Jan 1;136(1):195-203. doi: 10.1002/ijc.28961. Epub 2014 May 16. PMID 24811525

Identifiers

NCT: NCT06762548 · DA-007-CIA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗