Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorApplied Biology, Inc.
About this trial
Clinical Study of DA-007 As a Treatment for Chemotherapy Induced Alopecia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with stage I or stage II breast cancer
Scheduled but not begun, at least 4 cycles of taxane and/or anthracycline-based chemotherapy.
Ages 18-65
Able to give informed consent
Disqualifiers
Resting blood pressure outside the range of 105-140/ 55-99
Uncontrolled or severe hypertension
Female pattern hair loss or hair loss disorder
Folliculitis
Trial design
Design model
Parallel
Treatments tested in this trial
DA-007
DrugTopical α1 agonist combination of Phenylephrine + Tyramine + Synephrine
Placebo
DrugTopical placebo solution
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: DA-007Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Prevention of Hair Loss (Common Terminology Criteria for Adverse Events V5.0)
Amount of hair loss during chemotherapy treatment measured by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0. The Common Terminology Criteria for Adverse Events is a common terminology developed by the National Cancer Institute to describe and grade adverse events related to cancer therapy.
Time frame
Week [0,12]Secondary outcomes
1
Hair Re-Growth Post Treatment (Common Terminology Criteria for Adverse Events V5.0)
Amount of hair re-growth post chemotherapy treatment measured by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0. The Common Terminology Criteria for Adverse Events is a common terminology developed by the National Cancer Institute to describe and grade adverse events related to cancer therapy.
Time frame
Week [12, 24]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Applied Biology, Inc.
Lead sponsor
Daniel Alain, Inc.
Collaborator
Follea International Limited
Collaborator
Source ClinicalTrials.gov
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