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

NCT06762548 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: DA-007-CIA
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chemotherapy Induced Alopecia; Chemotherapy Side Effects

Keywords

Chemotherapy Induced Alopecia; Chemotherapy Alopecia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hair Re-Growth Post Treatment (Common Terminology Criteria for Adverse Events V5.0)

  Week [12, 24]

Study Arms (2)

DA-007

ACTIVE COMPARATOR

Topical DA-007 Solution

Drug: DA-007

Placebo

PLACEBO COMPARATOR

Topical Placebo Solution

Drug: Placebo

Interventions

DA-007 DRUG

Topical α1 agonist combination of Phenylephrine + Tyramine + Synephrine

DA-007

Placebo DRUG

Topical placebo solution

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Applied Biology, Inc.: lead
• Daniel Alain, Inc.: collaborator
• Follea International Limited: collaborator

Study Sites (1)

University of Rome ("G. Marconi")

Rome, Italy

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Andy Goren, MD

  University of Rome G. Marconi

  STUDY DIRECTOR

Central Study Contacts

Andy Goren, MD

CONTACT

16507040850; clinicalstudies@appliedbiology.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 7, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): September 11, 2026
• Study Completion (Estimated): November 6, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)