Chemotherapy Induced Alopecia, Chemotherapy Side Effects
Conditions
Keywords
Chemotherapy Induced Alopecia, Chemotherapy Alopecia
Brief summary
Pharmacokinetic Study of DA-020
Detailed description
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of DA-020
Interventions
DRUGDA-020 (0.1%)
DA-020 (0.1%)
DRUGDA-020 (0.2%)
DA-020 (0.2%)
DRUGDA-020 (0.5%)
DA-020 (0.5%)
Sponsors
Applied Biology, Inc.
Daniel Alain, Inc.
Follea International Limited
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of DA-020 in Serum | Hours [0, 1, 2, 4, 8, 12, 24] | Determine the amount of Oxymetazoline in serum after 1 time scalp application |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of DA-020 | Hours [0, 1, 2, 4, 8, 12, 24] | Determine blood pressure following a single application of DA-020 |
Countries
Brazil, Italy
Contacts
CONTACTAndy Goren, MD
STUDY_DIRECTORAndy Goren, MD
University of Rome G. Marconi
Outcome results
None listed