Phase 1 Study of Topical Phenylephrine on the Scalp in Healthy Adult Women Aged 18 to 55

What this Trial Is About

This research aims to evaluate the pharmacokinetics of topical phenylephrine applied to the scalp in healthy adult females. The study focuses on understanding how this treatment is absorbed and processed in the body, particularly in relation to chemotherapy-induced alopecia and chemotherapy side effects. It is an early phase 1, open-label study sponsored by Applied Biology, Inc. Participants will receive topical phenylephrine applied to the scalp. The study does not use masking or blinding, and all participants receive the investigational device. The treatment period and evaluations occur over a three-week timeframe, with assessments focused on the pharmacokinetic profile and safety of the product. During the study, participants will undergo regular monitoring to assess the pharmacokinetic profile of phenylephrine at specified intervals up to three weeks. Safety and tolerability will also be closely tracked. Participants must attend study visits for evaluations including clinical assessments and tests to ensure the scalp is free from irritation or damage. The total duration of involvement spans from initial application through the three-week monitoring period.

Pharmacokinetic Study of Topical Phenylephrine