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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2026-11-06

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chemotherapy Induced Alopecia Chemotherapy Side Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DA-007

Topical DA-007 Solution

Group Type ACTIVE_COMPARATOR

DA-007

Intervention Type DRUG

Topical α1 agonist combination of Phenylephrine + Tyramine + Synephrine

Placebo

Topical Placebo Solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Topical placebo solution

Interventions

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DA-007

Topical α1 agonist combination of Phenylephrine + Tyramine + Synephrine

Intervention Type DRUG

Placebo

Topical placebo solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No