Chemotherapy Induced AlopeciaPhase 1/2NCT07397325
Clinical Study of DA-020 for the Treatment of Chemotherapy Induced Alopecia
A Phase 1/2 study testing DA-020 and DA-020 and Hyperforin in people with Chemotherapy Induced Alopecia and Chemotherapy Side Effects, run by Applied Biology, Inc. at 2 sites in 2 countries.
Trial summary
Clinical Study of DA-020 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-020 and DA-020 and Hyperforin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 May 2026to 5 Mar 2027
- Phase
- Phase 1/2
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
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- 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
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Brazil1 site, 1 recruiting
- Recruiting
Hospital Samel
Manaus
Daniel Fonseca, MD, +55 92 2129-2200, clinicalstudies@appliedbilogy.com
Daniel Fonseca, MD
Italy1 site, 1 recruiting
- Not yet recruiting
University of Rome ("G. Marconi")
Rome
Andy Goren, MD, 16507040850, clinicalstudies@appliedbiology.com
About this study
Clinical Study of DA-020 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-020), 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-020 can reduce scalp blood perfusion and thus reduce hair loss due to chemotherapy.
- Being tested
- DA-020, Placebo, DA-020 and Hyperforin
- 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-020Drug
7mL application of DA-020 (Topical Oxymetazoline)
PlaceboDrug
Topical placebo solution
DA-020 and HyperforinDrug
7mL application of DA-020 (Topical Oxymetazoline) and Hyperforin (1.5%)
| Study group | Role | What they receive |
|---|---|---|
| DA-020 | Active comparator | Topical DA-020 Solution Receives: Drug: DA-020 |
| Placebo | Placebo comparator | Topical Placebo Solution Receives: Drug: Placebo |
| DA-020 and Hyperforin (1.5%) | Active comparator | DA-020 and Hyperforin (1.5%) Receives: Drug: DA-020 and Hyperforin |
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 posted9 Feb 2026
- Study start16 May 2026
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Mar 2027 (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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT07397325
- Sponsor's protocol ID
- DA-020-CIA
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2026
- Last updated
- 21 Aug 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