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NCT Number: NCT07033845

Pharmacokinetic Study of Topical Phenylephrine

Pharmacokinetic Study of Topical Phenylephrine

Recruiting

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Key information

Conditions

Chemotherapy Induced Alopecia Chemotherapy Side Effects

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Rome ("G. Marconi")

Rome, Italy

Location status: Recruiting

Location contact

Andy Goren, MD

CONTACT

[email protected]

16507040850

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenylephrine

Device

Topical Phenylephrine

Primary outcomes

  1. Pharmacokinetic profile of phenylephrine

    Time frame: 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 outcomes

  1. Safety and tolerability of phenylephrine

    Time frame: Week [0, 3]

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

Study contacts

Contact information is provided by the study sponsor or research team.

Andy Goren, MD

CONTACT

[email protected]

16507040850

Sponsors and collaborators

Lead sponsor

Applied Biology, Inc.

Industry

Collaborators

  • Daniel Alain, Inc.
  • Follea International Limited

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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