Pharmacokinetic Study of DA-020

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorApplied Biology, Inc.

About this trial

Pharmacokinetic Study of DA-020

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

  • DA-020 (0.1%)

    Drug

    DA-020 (0.1%)

  • DA-020 (0.2%)

    Drug

    DA-020 (0.2%)

  • DA-020 (0.5%)

    Drug

    DA-020 (0.5%)

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: DA-020 (0.1%)Experimental treatment 1 intervention
Group B: DA-020 (0.2%)Experimental treatment 1 intervention
Group C: DA-020 (0.5%)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Concentration of DA-020 in Serum

Determine the amount of Oxymetazoline in serum after 1 time scalp application

Time frame
Hours [0, 1, 2, 4, 8, 12, 24]

Secondary outcomes

1

Safety and tolerability of DA-020

Determine blood pressure following a single application of DA-020

Time frame
Hours [0, 1, 2, 4, 8, 12, 24]

Other outcomes

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

This trial is not recruiting at the moment. You can still explore other options: