Chemotherapy Induced Alopecia, Chemotherapy Side Effects
Conditions
Keywords
Chemotherapy Induced Alopecia, Chemotherapy Alopecia
Brief summary
Pharmacokinetic Study of Topical Phenylephrine
Detailed description
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of Topical Phenylephrine Applied to the Scalp in Healthy Adult Females
Interventions
DEVICEPhenylephrine
Topical Phenylephrine
Sponsors
Daniel Alain, Inc.
Follea International Limited
Applied Biology, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profile of phenylephrine | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of phenylephrine | Week [0, 3] | Determine blood pressure and dermatological adverse events following daily scalp application of topical phenylephrine for a period of 3 weeks |
Countries
Italy
Contacts
Primary ContactAndy Goren, MD
Outcome results
None listed