Pharmacokinetic Study of Topical Phenylephrine
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorApplied Biology, Inc.
About this trial
Pharmacokinetic Study of Topical Phenylephrine
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Phenylephrine
DeviceTopical Phenylephrine
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: PhenylephrineExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Week [0,3]Secondary outcomes
1
Safety and tolerability of phenylephrine
Determine blood pressure and dermatological adverse events following daily scalp application of topical phenylephrine for a period of 3 weeks
Time frame
Week [0, 3]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Applied Biology, Inc.
Lead sponsor
Daniel Alain, Inc.
Collaborator
Follea International Limited
Collaborator
Source ClinicalTrials.gov