Pharmacokinetic Study of DA-020

April 8, 2026 updated by: Applied Biology, Inc.
Pharmacokinetic Study of DA-020

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of DA-020

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DA-020 (0.1%)
Topical Oxymetazoline 0.1% - 7mL
Drug: DA-020 (0.1%)
DA-020 (0.1%)
Experimental: DA-020 (0.2%)
Topical Oxymetazoline 0.2% - 7mL
Drug: DA-020 (0.2%)
DA-020 (0.2%)
Experimental: DA-020 (0.5%)
Topical Oxymetazoline 0.5% - 7mL
Drug: DA-020 (0.5%)
DA-020 (0.5%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of DA-020 in Serum
Time Frame: Hours [0, 1, 2, 4, 8, 12, 24]
Determine the amount of Oxymetazoline in serum after 1 time scalp application
Hours [0, 1, 2, 4, 8, 12, 24]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of DA-020
Time Frame: Hours [0, 1, 2, 4, 8, 12, 24]
Determine blood pressure following a single application of DA-020
Hours [0, 1, 2, 4, 8, 12, 24]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Biology, Inc.

Collaborators

Follea International Limited
Daniel Alain, Inc.

Investigators

  • Study Director: Andy Goren, MD, University of Rome G. Marconi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 16, 2026

Primary Completion (Estimated)

October 19, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 7, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DA-020-PK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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