Pharmacokinetic Study of Topical Phenylephrine

Early Phase 1RecruitingNCT07033845

Applied Biology, Inc.24 enrolled

Overview

A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of Topical Phenylephrine Applied to the Scalp in Healthy Adult Females

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chemotherapy Induced Alopecia Chemotherapy Side Effects

Interventions

PhenylephrineDEVICE

Topical Phenylephrine

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy females, age 18-55 * BMI: 18-30 kg/m² * Fitzpatrick Skin Types I-IV (to standardize absorption risk) * Scalp free from irritation, dermatologic disease, or damage * Able to refrain from using other topical scalp products Exclusion Criteria: * History of cardiovascular disease, hypertension, or arrhythmia * Scalp infections, wounds, or significant hair loss * Recent use of medications that interfere with CYP enzymes or adrenergic systems * Known sensitivity to phenylephrine or ethanol * Positive drug screen or abnormal ECG at screening

Locations (1)

University of Rome ("G. Marconi")

Rome, Italy

RECRUITING

Outcomes

Primary Outcomes

Pharmacokinetic profile of phenylephrine

Determine the amount of phenylephrine and its metabolites in serum daily scalp application of topical phenylephrine for a period of 3 weeks

Time frame: Week [0,3]

Secondary Outcomes

Safety and tolerability of phenylephrine

Determine blood pressure and dermatological adverse events following daily scalp application of topical phenylephrine for a period of 3 weeks

Time frame: Week [0, 3]

Central Contacts

Andy Goren, MD

CONTACT

16507040850 clinicalstudies@appliedbiology.com

Data from ClinicalTrials.gov

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