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

Phase 3

Not yet recruiting

• Conditions: Chemotherapy Induced Alopecia; Chemotherapy Side Effects
• Interventions: Drug: DA-007; Drug: Placebo

• Registration Number: NCT06762548
• Lead Sponsor: Applied Biology, Inc.

Brief Summary

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.

Study Timeline

• Study First Submitted: 2025-01-01
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Study Start: 2025-10-10
• Primary Completion: 2026-09-11
• Study Completion: 2026-11-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-007	DA-007	Topical DA-007 Solution
Placebo	Placebo	Topical Placebo Solution

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Hair Re-Growth Post Treatment (Common Terminology Criteria for Adverse Events V5.0)	Week [12, 24]	Amount of hair re-growth post 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 Locations

Locations (1)

University of Rome ("G. Marconi"); 🇮🇹 Rome, Italy