Topical phenylephrine applied to the scalp to measure absorption
Pharmacokinetic Study of Topical Phenylephrine
EARLY_PHASE1 · Applied Biology, Inc. · NCT07033845
This will test how much topical phenylephrine is absorbed through the scalp in healthy women ages 18-55.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Applied Biology, Inc. (industry) |
| Locations | 1 site (Rome) |
| Trial ID | NCT07033845 on ClinicalTrials.gov |
What this trial studies
An open-label Phase 1 pharmacokinetic study measuring systemic exposure after topical phenylephrine is applied to the scalp of healthy adult women. Participants are healthy females aged 18-55 with BMI 18-30 and Fitzpatrick skin types I-IV, and must have an intact, non-irritated scalp. Blood samples and safety monitoring including ECGs will be collected over defined timepoints to characterize absorption, clearance, and immediate safety. Results will guide dosing and safety decisions for future development aimed at chemotherapy-related hair loss.
Who should consider this trial
Good fit: Healthy women 18-55 with BMI 18-30, Fitzpatrick skin types I-IV, undamaged scalps, no cardiovascular disease, and not taking CYP- or adrenergic-interacting medications are ideal candidates.
Not a fit: People currently receiving chemotherapy, those with significant hair loss or scalp disease, or anyone with cardiovascular disease or known sensitivity to phenylephrine are unlikely to receive direct benefit from this pharmacokinetic study.
Why it matters
Potential benefit: If successful, the results could show low systemic absorption and an acceptable safety profile that supports further development of a topical approach to reduce chemotherapy-related hair loss.
How similar studies have performed: This application is relatively novel for scalp use—phenylephrine's systemic effects are established, but there are limited clinical data on topical scalp application for preventing chemotherapy-related hair loss.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome
- University of Rome ("G. Marconi") — Rome, Italy (RECRUITING)
Study contacts
- Study coordinator: Andy Goren, MD
- Email: clinicalstudies@appliedbiology.com
- Phone: 16507040850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chemotherapy Induced Alopecia, Chemotherapy Side Effects, Chemotherapy Alopecia