NCT06762548

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Applied Biology, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy Induced Alopecia
• Chemotherapy Side Effects

Interventions

Type	Name	Description
DRUG	DA-007	Topical α1 agonist combination of Phenylephrine + Tyramine + Synephrine
DRUG	Placebo	Topical placebo solution

Timeline

• Start date: 2025-10-10
• Primary completion: 2026-09-11
• Completion: 2026-11-06
• First posted: 2025-01-07
• Last updated: 2025-05-23

Locations

1 site across 1 country: Italy