Pharmacokinetic Study of Topical Phenylephrine

NCT ID: NCT07033845

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2025-12-28

Brief Summary

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Pharmacokinetic Study of Topical Phenylephrine

Detailed Description

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

Conditions

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Chemotherapy Induced Alopecia Chemotherapy Side Effects

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phenylephrine

Topical Phenylephrine

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DEVICE

Topical Phenylephrine

Interventions

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Phenylephrine

Topical Phenylephrine

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Daniel Alain, Inc.

UNKNOWN

Sponsor Role collaborator

Follea International Limited

INDUSTRY

Sponsor Role collaborator

Applied Biology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andy Goren, MD

Role: STUDY_DIRECTOR

University of Rome G. Marconi

Locations

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University of Rome ("G. Marconi")

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andy Goren, MD

Role: CONTACT

16507040850

Facility Contacts

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Andy Goren, MD

Role: primary

16507040850

References

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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.

Reference Type BACKGROUND
PMID: 27704205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24811525 (View on PubMed)

Other Identifiers

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DA-PK-001

Identifier Type: -

Identifier Source: org_study_id

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