NCT07033845

Brief Summary

Pharmacokinetic Study of Topical Phenylephrine

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2025

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

May 22, 2025

Last Update Submit

September 30, 2025

Conditions

Chemotherapy Induced AlopeciaChemotherapy Side Effects

Keywords

Chemotherapy Induced AlopeciaChemotherapy Alopecia

Outcome Measures

Primary Outcomes (1)

  • 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

    Week [0,3]

Secondary Outcomes (1)

  • Safety and tolerability of phenylephrine

    Week [0, 3]

Study Arms (1)

Phenylephrine

EXPERIMENTAL

Topical Phenylephrine

Device: Phenylephrine

Interventions

PhenylephrineDEVICE

Topical Phenylephrine

Phenylephrine

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rome ("G. Marconi")

Rome, Italy

RECRUITING

Related Publications (2)

  • Fahl WE. Complete prevention of radiation-induced dermatitis using topical adrenergic vasoconstrictors. Arch Dermatol Res. 2016 Dec;308(10):751-757. doi: 10.1007/s00403-016-1691-2. Epub 2016 Oct 4.

    PMID: 27704205BACKGROUND

  • Soref CM, Fahl WE. A new strategy to prevent chemotherapy and radiotherapy-induced alopecia using topically applied vasoconstrictor. Int J Cancer. 2015 Jan 1;136(1):195-203. doi: 10.1002/ijc.28961. Epub 2014 May 16.

    PMID: 24811525BACKGROUND

Study Officials

  • Andy Goren, MD

    University of Rome G. Marconi

    STUDY DIRECTOR

Central Study Contacts

Andy Goren, MD

CONTACT

16507040850clinicalstudies@appliedbiology.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

June 24, 2025

Study Start

June 30, 2025

Primary Completion

October 19, 2025

Study Completion

December 28, 2025

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)