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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chemotherapy Side Effects; Chemotherapy Induced Alopecia
• Intervention / Treatment: Drug: DA-007; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Andy Goren, MD; Phone Number: 16507040850; Email: clinicalstudies@appliedbiology.com

Study Locations

• Italy
  • Rome, Italy
    • University of Rome ("G. Marconi")
    • Contact: Andy Goren, MD; Phone Number: 16507040850; Email: clinicalstudies@appliedbiology.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DA-007; Topical DA-007 Solution	Drug: DA-007; Topical α1 agonist combination of Phenylephrine + Tyramine + Synephrine
Placebo Comparator: Placebo; Topical Placebo Solution	Drug: Placebo; Topical placebo solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of Hair Loss (Common Terminology Criteria for Adverse Events V5.0)	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.	Week [0,12]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair Re-Growth Post Treatment (Common Terminology Criteria for Adverse Events V5.0)	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.	Week [12, 24]

Collaborators and Investigators

• Sponsor: Applied Biology, Inc.
• Collaborators: Follea International Limited; Daniel Alain, Inc.
• Investigators: Study Director: Andy Goren, MD, University of Rome G. Marconi

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 10, 2025
• Primary Completion (Estimated): September 11, 2026
• Study Completion (Estimated): November 6, 2026

Study Registration Dates

• First Submitted: January 1, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 7, 2025

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Chemotherapy Induced Alopecia; Chemotherapy Alopecia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia Areata; Alopecia
• Other Study ID Numbers: DA-007-CIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No