Pharmacokinetic Study of Topical Phenylephrine

Applied Biology

Status and phase: Enrolling; Early Phase 1

Conditions: Chemotherapy Side Effects; Chemotherapy Induced Alopecia

Treatments: Device: Phenylephrine

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07033845

DA-PK-001

Details and patient eligibility

About

Pharmacokinetic Study of Topical Phenylephrine

Full description

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

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

Phenylephrine

Experimental group

Description:

Topical Phenylephrine

Treatment:

Device: Phenylephrine