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

Applied Biology

Status and phase: Not yet enrolling; Phase 3

Conditions: Chemotherapy Side Effects; Chemotherapy Induced Alopecia

Treatments: Drug: Placebo; Drug: DA-007

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06762548

DA-007-CIA

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

DA-007

Active Comparator group

Description:

Topical DA-007 Solution

Treatment:

Drug: DA-007

Placebo

Placebo Comparator group

Description:

Topical Placebo Solution

Treatment:

Drug: Placebo