Chemotherapy Induced AlopeciaEarly Phase 1NCT07402330
Pharmacokinetic Study of DA-020
A Early Phase 1 study testing DA-020 (0.1%), DA-020 (0.2%) and DA-020 (0.5%) in people with Chemotherapy Induced Alopecia and Chemotherapy Side Effects, run by Applied Biology, Inc. at 2 sites in 2 countries.
Trial summary
Pharmacokinetic Study of DA-020 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy Induced Alopecia, Chemotherapy Side Effects
- What is being tested?
- DA-020 (0.1%), DA-020 (0.2%) and DA-020 (0.5%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Apr 2026to 30 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Pharmacokinetic Study of DA-020
Read the detailed description
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of DA-020
- Being tested
- DA-020 (0.1%), DA-020 (0.2%), DA-020 (0.5%)
- Keywords
- Chemotherapy Induced Alopecia, Chemotherapy Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-020 (0.1%)Drug
DA-020 (0.1%)
DA-020 (0.2%)Drug
DA-020 (0.2%)
DA-020 (0.5%)Drug
DA-020 (0.5%)
| Study group | Role | What they receive |
|---|---|---|
| DA-020 (0.1%) | Experimental | Topical Oxymetazoline 0.1% - 7mL Receives: Drug: DA-020 (0.1%) |
| DA-020 (0.2%) | Experimental | Topical Oxymetazoline 0.2% - 7mL Receives: Drug: DA-020 (0.2%) |
| DA-020 (0.5%) | Experimental | Topical Oxymetazoline 0.5% - 7mL Receives: Drug: DA-020 (0.5%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of DA-020 in Serum
Determine the amount of Oxymetazoline in serum after 1 time scalp application
Measured: Hours [0, 1, 2, 4, 8, 12, 24]
Secondary outcomes (1)
Safety and tolerability of DA-020
Determine blood pressure following a single application of DA-020
Measured: Hours [0, 1, 2, 4, 8, 12, 24]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start16 Apr 2026
- Primary completion19 Oct 2026
- Study completion30 Oct 2026
Why it stopped: Change of protocol moved to new study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daniel Alain, Inc., Follea International Limited
- Responsible party
- Sponsor
- Investigators
- Andy Goren, MD, Study director, University of Rome G. Marconi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402330
- Sponsor's protocol ID
- DA-020-PK
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27704205Soref 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.
PubMed 24811525
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of DA-020
- ClinicalTrials.gov ID
- NCT07402330
- Acronym / sponsor ID
- DA-020-PK
- Keywords
- Chemotherapy Induced Alopecia, Chemotherapy Alopecia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of protocol moved to new study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Daniel Alain, Inc., Follea International Limited
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 19 Oct 2026 (actual)
- Study completion
- 30 Oct 2026 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacokinetic Study of DA-020
Detailed description
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of DA-020
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DA-020 (0.1%) | Experimental | Drug: DA-020 (0.1%)Topical Oxymetazoline 0.1% - 7mL |
| DA-020 (0.2%) | Experimental | Drug: DA-020 (0.2%)Topical Oxymetazoline 0.2% - 7mL |
| DA-020 (0.5%) | Experimental | Drug: DA-020 (0.5%)Topical Oxymetazoline 0.5% - 7mL |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-020 (0.1%)DA-020 (0.1%) | Drug | DA-020 (0.1%) |
| DA-020 (0.2%)DA-020 (0.2%) | Drug | DA-020 (0.2%) |
| DA-020 (0.5%)DA-020 (0.5%) | Drug | DA-020 (0.5%) |
Primary outcome
Concentration of DA-020 in Serum
Time frame: Hours [0, 1, 2, 4, 8, 12, 24]
Determine the amount of Oxymetazoline in serum after 1 time scalp application
1 secondary outcome
Safety and tolerability of DA-020
Time frame: Hours [0, 1, 2, 4, 8, 12, 24]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 27704205Fahl 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.
- Background: PubMed 24811525Soref 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Goren, MD study director
University of Rome G. Marconi
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DA-020 (0.1%), DA-020 (0.2%) and DA-020 (0.5%) in people with Chemotherapy Induced Alopecia and Chemotherapy Side Effects, run by Applied Biology, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of DA-020 in Serum (time frame: Hours [0, 1, 2, 4, 8, 12, 24]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07402330, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026; AzTrials last refreshed its copy on 4 Nov 2026.