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NCT Number: NCT07402330

Pharmacokinetic Study of DA-020

Pharmacokinetic Study of DA-020

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Key information

Conditions

Chemotherapy Induced Alopecia Chemotherapy Side Effects

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Hospital Samel, Manaus, Brazil

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Andy Goren, MD

CONTACT

[email protected]

16507040850

Sponsors and collaborators

Lead sponsor

Applied Biology, Inc.

Industry

Collaborators

  • Daniel Alain, Inc.
  • Follea International Limited

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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