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Clinical Trials in Italy / NCT06762548
Starting soon Phase 3

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

NCT06762548 · tracked via the Priya Life Science Italy tracker
Sponsor
Applied Biology, Inc
Phase
Phase 3
Started
2025-10-10
Last updated
2025-05-23

Condition(s) studied

Chemotherapy Induced AlopeciaChemotherapy Side Effects

Investigational drug(s) / intervention(s)

DA-007Placebo

DA-007: Topical α1 agonist combination of Phenylephrine + Tyramine + Synephrine

Placebo: Topical placebo solution

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Prevention of Hair Loss (Common Terminology Criteria for Adverse Events V5.0) — Week [0,12]
    Amount of hair loss during chemotherapy treatment measured by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0. The Common Terminology Criteria for Adverse Events is a common terminology developed by the National Cancer Institute to describe and grade adverse events related to cancer therapy.

Trial sites (1)

FacilityCityRegionStatus
University of Rome ("G. Marconi") Rome Italy

More Applied Biology, Inc. trials in Italy

Pharmacokinetic Study of DA-020 Starting soon
Clinical Study of DA-020 for the Treatment of Chemotherapy Induced Alopecia Recruiting
Pharmacokinetic Study of Topical Phenylephrine Recruiting

Other trials for the same condition

Pharmacokinetic Study of DA-020 Starting soon
Clinical Study of DA-020 for the Treatment of Chemotherapy Induced Alopecia Recruiting
Pharmacokinetic Study of Topical Phenylephrine Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06762548 on ClinicalTrials.gov ↗ ← All trials in Italy