Pharmacokinetic Study of Topical Phenylephrine

Phase 1

Not yet recruiting

• Conditions: Chemotherapy Induced Alopecia; Chemotherapy Side Effects

• Registration Number: NCT07033845
• Lead Sponsor: Applied Biology, Inc.

Brief Summary

Pharmacokinetic Study of Topical Phenylephrine

Detailed Description

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

Study Timeline

• Study First Submitted: 2025-05-22
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-14
• Last Update Submitted: 2025-06-14
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Study Start: 2025-06-30
• Primary Completion: 2025-10-19
• Study Completion: 2025-12-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of phenylephrine	Week [0,3]	Determine the amount of phenylephrine and its metabolites in serum daily scalp application of topical phenylephrine for a period of 3 weeks

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of phenylephrine	Week [0, 3]	Determine blood pressure and dermatological adverse events following daily scalp application of topical phenylephrine for a period of 3 weeks

Trial Locations

Locations (1)

University of Rome ("G. Marconi"); 🇮🇹 Rome, Italy