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

Phase 3Not Yet RecruitingNCT06762548

Applied Biology, Inc.140 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

140

Conditions

Chemotherapy Induced Alopecia Chemotherapy Side Effects

Interventions

DA-007DRUG

Topical α1 agonist combination of Phenylephrine + Tyramine + Synephrine

PlaceboDRUG

Topical placebo solution

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Rome ("G. Marconi")

Rome, Italy

Outcomes

Primary Outcomes

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.

Time frame: Week [0,12]

Secondary Outcomes

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.

Time frame: Week [12, 24]

Central Contacts

Andy Goren, MD

CONTACT

16507040850 clinicalstudies@appliedbiology.com

Data from ClinicalTrials.gov

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