Clinical trial NCT06762548: Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia
Official title: Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chemotherapy Induced Alopecia
Chemotherapy Side Effects
Keywords: Chemotherapy Induced Alopecia
Chemotherapy Alopecia
Lead sponsor: Applied Biology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Daniel Alain, Inc.
name: Follea International Limited
First posted: 2025-01-07
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevention of Hair Loss (Common Terminology Criteria for Adverse Events V5.0)
timeFrame: Week [0,12]
Secondary outcomes:
measure: Hair Re-Growth Post Treatment (Common Terminology Criteria for Adverse Events V5.0)
timeFrame: Week [12, 24]
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of Rome ("G. Marconi")
Study officials:
affiliation: University of Rome G. Marconi
name: Andy Goren, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.