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ClinicalTrials.gov ID

NCT07402330

Lead Sponsor

Applied Biology, Inc.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Early Phase 1

Enrollment

60Estimated

Last Update Posted

Apr 13, 2026Actual

Start Date

Apr 16, 2026Estimated

Primary Completion Date

Oct 19, 2026Estimated

Completion Date

Nov 30, 2026Estimated

Official Title

Pharmacokinetic Study of DA-020

Brief Summary

Pharmacokinetic Study of DA-020

Detailed Description

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

• Chemotherapy Induced Alopecia
• Chemotherapy Side Effects

• DA-020 (0.1%)
• DA-020 (0.2%)
• DA-020 (0.5%)

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

Applied Biology, Inc.INDUSTRY

Collaborators

Daniel Alain, Inc.INDUSTRY

Follea International LimitedINDUSTRY

clinicalstudies@appliedbiology.com16507040850