Complete prevention of radiation-induced dermatitis using topical adrenergic vasoconstrictors.
William E Fahl
https://pubmed.ncbi.nlm.nih.gov/27704205Actively Recruiting
Early Phase 1
Age: 18Years - 55Years
FEMALE
Healthy Volunteers
ID07033845
Pharmacokinetic Study of Topical Phenylephrine Applied to the Scalp in Healthy Adult Females
Led by Applied Biology, Inc. · Updated on 2025-10-03
24
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
Sponsors
A
Applied Biology, Inc.
Lead Sponsor
D
Daniel Alain, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the pharmacokinetics of topical phenylephrine applied to the scalp in healthy adult females. The study focuses on understanding how this treatment is absorbed and processed in the body, particularly in relation to chemotherapy-induced alopecia and chemotherapy side effects. It is an early phase 1, open-label study sponsored by Applied Biology, Inc. Participants will receive topical phenylephrine applied to the scalp. The study does not use masking or blinding, and all participants receive the investigational device. The treatment period and evaluations occur over a three-week timeframe, with assessments focused on the pharmacokinetic profile and safety of the product. During the study, participants will undergo regular monitoring to assess the pharmacokinetic profile of phenylephrine at specified intervals up to three weeks. Safety and tolerability will also be closely tracked. Participants must attend study visits for evaluations including clinical assessments and tests to ensure the scalp is free from irritation or damage. The total duration of involvement spans from initial application through the three-week monitoring period.
CONDITIONS
Brief Title
Pharmacokinetic Study of Topical Phenylephrine
Who Can Participate
Age: 18Years - 55Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy females, age 18-55
- Body mass index (BMI) between 18 and 30 kg/m²
- Fitzpatrick Skin Types I-IV to standardize absorption risk
- Scalp free from irritation, skin disease, or damage
- Able to avoid using other topical scalp products during the study
You will not qualify if you...
- History of cardiovascular disease, hypertension, or arrhythmia
- Scalp infections, wounds, or significant hair loss
- Recent use of medications that affect CYP enzymes or adrenergic systems
- Known sensitivity to phenylephrine or ethanol
- Positive drug screen or abnormal ECG at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 3 weeks
Participants receive topical phenylephrine applied to the scalp to evaluate its pharmacokinetics and safety.
Multiple visits during the 3-week treatment period
Trial Site Locations
Total: 1 location
1
University of Rome ("G. Marconi")
Rome, Italy
Actively Recruiting
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Research Team
A
Andy Goren, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
A new strategy to prevent chemotherapy and radiotherapy-induced alopecia using topically applied vasoconstrictor.
Cheryl M Soref, William E Fahl
https://pubmed.ncbi.nlm.nih.gov/24811525