Not yet recruiting NCT07402330
Pharmacokinetic Study of DA-020
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DA-020 (0.1%), DA-020 (0.2%), DA-020 (0.5%).
- Who it may be relevant to
- Registry conditions: Chemotherapy Induced Alopecia, Chemotherapy Side Effects. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Pharmacokinetic Study of DA-020
Detailed description
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of DA-020
Interventions
- Drug DA-020 (0.1%)
DA-020 (0.1%) - Drug DA-020 (0.2%)
DA-020 (0.2%) - Drug DA-020 (0.5%)
DA-020 (0.5%)
Primary outcome measures
- Concentration of DA-020 in Serum [Time frame: Hours [0, 1, 2, 4, 8, 12, 24]]
Secondary outcome measures (1)
- Safety and tolerability of DA-020 [Time frame: Hours [0, 1, 2, 4, 8, 12, 24]]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Hospital Samel — Manaus
Italy · 1 center
- University of Rome ("G. Marconi") — Rome
Publications
- 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 27704205
- 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 24811525
Identifiers
NCT: NCT07402330 · DA-020-PK