Chemotherapy Induced AlopeciaPhase 3NCT06762548
Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia
A Phase 3 study testing DA-007 in people with Chemotherapy Induced Alopecia and Chemotherapy Side Effects, run by Applied Biology, Inc. at 1 site in Italy.
Trial summary
Clinical Study of DA-007 As a Treatment for Chemotherapy Induced Alopecia Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chemotherapy Induced Alopecia, Chemotherapy Side Effects
- What is being tested?
- DA-007
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2027to 6 Nov 2028
- Phase
- Phase 3
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Resting blood pressure outside the range of 105-140/ 55-99
- Uncontrolled or severe hypertension
- Female pattern hair loss or hair loss disorder
- Folliculitis
- Scalp psoriasis
- Seborrheic dermatitis
Show all 10Show fewer
- Inflammatory scalp conditions such as lichen planopillaris
- Subjects wearing wigs prior to chemotherapy
- Use of MAO inhibitors
- Unable to provide consent or make allotted clinical visits
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
University of Rome ("G. Marconi")
Rome
Andy Goren, MD, 16507040850, clinicalstudies@appliedbiology.com
About this study
Clinical Study of DA-007 As a Treatment for Chemotherapy Induced Alopecia
Read the detailed description
Chemotherapy induced alopecia (CIA) is a common adverse event of oncological treatment. The significant psychological burden of CIA, particularly in women, leads some (~8%) to reject life saving therapeutic regimens. Several studies have demonstrated the effectiveness of scalp vasoconstriction as a prophylactic treatment for CIA. Recently, US Food and Drug Administration (FDA) approved a scalp-cooling device as a prophylactic treatment for CIA. Scalp cooling results in reduced local blood perfusion and consequently reduced chemotherapeutic agents reaching the hair follicle niche; however, scalp cooling requires prolongation of the time required to attend the chemotherapy unit (>2 hrs) as well as common adverse events including intolerance to cold. A previous study demonstrated that the α1 agonist, phenylephrine hydrochloride, applied topically can penetrate the scalp and bind α1 receptors. As such, a topically applied α1 agonist would reduce scalp blood perfusion. A novel formula (DA-007), containing an α1 agonist, that can also penetrate the scalp and bind α1 receptors. The aim of the study is to test the hypothesis that DA-007 can reduce scalp blood perfusion and thus reduce hair loss due to chemotherapy.
- Being tested
- DA-007, Placebo
- 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-007Drug
Topical α1 agonist combination of Phenylephrine + Tyramine + Synephrine
PlaceboDrug
Topical placebo solution
| Study group | Role | What they receive |
|---|---|---|
| DA-007 | Active comparator | Topical DA-007 Solution Receives: Drug: DA-007 |
| Placebo | Placebo comparator | Topical Placebo Solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week [12, 24]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start10 Oct 2027 (estimated)
- Primary completion11 Mar 2028 (estimated)
- Study completion6 Nov 2028 (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
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 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
- NCT06762548
- Sponsor's protocol ID
- DA-007-CIA
- Status last verified
- Oct 2026
- First submitted
- 1 Jan 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia
- ClinicalTrials.gov ID
- NCT06762548
- Acronym / sponsor ID
- DA-007-CIA
- Keywords
- Chemotherapy Induced Alopecia, Chemotherapy Alopecia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Daniel Alain, Inc., Follea International Limited
- Study start
- 10 Oct 2027 (estimated)
- Primary completion
- 11 Mar 2028 (estimated)
- Study completion
- 6 Nov 2028 (estimated)
- First posted
- 7 Jan 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.
Clinical Study of DA-007 As a Treatment for Chemotherapy Induced Alopecia
Detailed description
Chemotherapy induced alopecia (CIA) is a common adverse event of oncological treatment. The significant psychological burden of CIA, particularly in women, leads some (~8%) to reject life saving therapeutic regimens. Several studies have demonstrated the effectiveness of scalp vasoconstriction as a prophylactic treatment for CIA. Recently, US Food and Drug Administration (FDA) approved a scalp-cooling device as a prophylactic treatment for CIA. Scalp cooling results in reduced local blood perfusion and consequently reduced chemotherapeutic agents reaching the hair follicle niche; however, scalp cooling requires prolongation of the time required to attend the chemotherapy unit (>2 hrs) as well as common adverse events including intolerance to cold. A previous study demonstrated that the α1 agonist, phenylephrine hydrochloride, applied topically can penetrate the scalp and bind α1 receptors. As such, a topically applied α1 agonist would reduce scalp blood perfusion. A novel formula (DA-007), containing an α1 agonist, that can also penetrate the scalp and bind α1 receptors. The aim of the study is to test the hypothesis that DA-007 can reduce scalp blood perfusion and thus reduce hair loss due to chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-007 | Active comparator | Drug: DA-007Topical DA-007 Solution |
| Placebo | Placebo comparator | Drug: PlaceboTopical Placebo Solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Resting blood pressure outside the range of 105-140/ 55-99
- Uncontrolled or severe hypertension
- Female pattern hair loss or hair loss disorder
- Folliculitis
- Scalp psoriasis
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-007Topical α1 agonist combination of Phenylephrine + Tyramine + Synephrine | Drug | DA-007 |
| PlaceboTopical placebo solution | Drug | Placebo |
Primary outcome
Prevention of Hair Loss (Common Terminology Criteria for Adverse Events V5.0)
Time frame: Week [0,12]
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.
1 secondary outcome
Hair Re-Growth Post Treatment (Common Terminology Criteria for Adverse Events V5.0)
Time frame: Week [12, 24]
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 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.
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 Phase 3 study testing DA-007 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 4 inclusion and 10 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: opening soon, 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 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. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Prevention of Hair Loss (Common Terminology Criteria for Adverse Events V5.0) (time frame: Week [0,12]). 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 NCT06762548, 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.