NCT07402330

Brief Summary

Pharmacokinetic Study of DA-020

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
7mo left

Started Apr 2026

Shorter than P25 for early_phase_1

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Nov 2026

First Submitted

Initial submission to the registry

February 2, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

February 2, 2026

Last Update Submit

April 8, 2026

Conditions

Chemotherapy Induced AlopeciaChemotherapy Side Effects

Keywords

Chemotherapy Induced AlopeciaChemotherapy Alopecia

Outcome Measures

Primary Outcomes (1)

  • Concentration of DA-020 in Serum

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

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

Secondary Outcomes (1)

  • Safety and tolerability of DA-020

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

Study Arms (3)

DA-020 (0.1%)

EXPERIMENTAL

Topical Oxymetazoline 0.1% - 7mL

Drug: DA-020 (0.1%)

DA-020 (0.2%)

EXPERIMENTAL

Topical Oxymetazoline 0.2% - 7mL

Drug: DA-020 (0.2%)

DA-020 (0.5%)

EXPERIMENTAL

Topical Oxymetazoline 0.5% - 7mL

Drug: DA-020 (0.5%)

Interventions

DA-020 (0.1%)DRUG

DA-020 (0.1%)

DA-020 (0.1%)
DA-020 (0.2%)DRUG

DA-020 (0.2%)

DA-020 (0.2%)
DA-020 (0.5%)DRUG

DA-020 (0.5%)

DA-020 (0.5%)

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Samel

Manaus, Brazil

Location

University of Rome ("G. Marconi")

Rome, Italy

Location

Related Publications (2)

  • Fahl WE. Complete prevention of radiation-induced dermatitis using topical adrenergic vasoconstrictors. Arch Dermatol Res. 2016 Dec;308(10):751-757. doi: 10.1007/s00403-016-1691-2. Epub 2016 Oct 4.

    PMID: 27704205BACKGROUND

  • Soref CM, Fahl WE. A new strategy to prevent chemotherapy and radiotherapy-induced alopecia using topically applied vasoconstrictor. Int J Cancer. 2015 Jan 1;136(1):195-203. doi: 10.1002/ijc.28961. Epub 2014 May 16.

    PMID: 24811525BACKGROUND

Study Officials

  • Andy Goren, MD

    University of Rome G. Marconi

    STUDY DIRECTOR

Central Study Contacts

Andy Goren, MD

CONTACT

16507040850clinicalstudies@appliedbiology.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 11, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

October 19, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)BR(1)