Chemotherapy Induced AlopeciaEarly Phase 1NCT07033845
Pharmacokinetic Study of Topical Phenylephrine
A Early Phase 1 study testing Phenylephrine in people with Chemotherapy Induced Alopecia and Chemotherapy Side Effects, run by Applied Biology, Inc. at 1 site in Italy.
Trial summary
Pharmacokinetic Study of Topical Phenylephrine 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?
- Phenylephrine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2025to 28 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Rome ("G. Marconi")
Rome
Andy Goren, MD, 16507040850, clinicalstudies@appliedbiology.com
About this study
Pharmacokinetic Study of Topical Phenylephrine
Read the detailed description
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of Topical Phenylephrine Applied to the Scalp in Healthy Adult Females
- Being tested
- Phenylephrine
- 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.
PhenylephrineDevice
Topical Phenylephrine
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Experimental | Topical Phenylephrine Receives: Device: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of phenylephrine
Determine the amount of phenylephrine and its metabolites in serum daily scalp application of topical phenylephrine for a period of 3 weeks
Measured: Week [0,3]
Secondary outcomes (1)
Safety and tolerability of phenylephrine
Determine blood pressure and dermatological adverse events following daily scalp application of topical phenylephrine for a period of 3 weeks
Measured: Week [0, 3]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start30 Jun 2025
- Primary completion19 Oct 2025 (estimated)
- Study completion28 Dec 2025 (estimated)
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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
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
- NCT07033845
- Sponsor's protocol ID
- DA-PK-001
- Status last verified
- Sep 2025
- First submitted
- 22 May 2025
- Last updated
- 3 Oct 2025
- 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 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Topical Phenylephrine
- ClinicalTrials.gov ID
- NCT07033845
- Acronym / sponsor ID
- DA-PK-001
- Keywords
- Chemotherapy Induced Alopecia, Chemotherapy Alopecia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Daniel Alain, Inc., Follea International Limited
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 19 Oct 2025 (estimated)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 24 Jun 2025 (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 Topical Phenylephrine
Detailed description
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of Topical Phenylephrine Applied to the Scalp in Healthy Adult Females
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Experimental | Device: PhenylephrineTopical Phenylephrine |
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 |
|---|---|---|
| PhenylephrineTopical Phenylephrine | Device | Phenylephrine |
Primary outcome
Pharmacokinetic profile of phenylephrine
Time frame: Week [0,3]
Determine the amount of phenylephrine and its metabolites in serum daily scalp application of topical phenylephrine for a period of 3 weeks
1 secondary outcome
Safety and tolerability of phenylephrine
Time frame: Week [0, 3]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- 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.
Andy Goren, MD study director
University of Rome G. Marconi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Phenylephrine in people with Chemotherapy Induced Alopecia and Chemotherapy Side Effects, run by Applied Biology, Inc. at 1 site in Italy.
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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andy Goren, MD (16507040850, clinicalstudies@appliedbiology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile of phenylephrine (time frame: Week [0,3]). 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 NCT07033845, 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 3 Oct 2025; AzTrials last refreshed its copy on 2 Nov 2026.