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Clinical Study of DA-020 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-020), 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-020 can reduce scalp blood perfusion and thus reduce hair loss due to chemotherapy.
Age
18 - 65 years
Sex
FEMALE
Healthy Volunteers
No
University of Rome ("G. Marconi")
Rome, Italy
Start Date
March 16, 2026
Primary Completion Date
October 5, 2026
Completion Date
December 7, 2026
Last Updated
February 11, 2026
60
ESTIMATED participants
DA-020
DRUG
Placebo
DRUG
DA-020 and Hyperforin
DRUG
Lead Sponsor
Applied Biology, Inc.
Collaborators
NCT06725953
NCT07201389
Data Source & Attribution
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