Telogen EffluviumPhase 2/3NCT06648850
Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth
A Phase 2/3 study testing DA-001, Phenylephrine and DA-001 Topical + DA-005 Oral (HIF-1α supplement) in people with Telogen Effluvium and Female Pattern Hair Loss, run by Applied Biology, Inc..
Trial summary
The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telogen Effluvium, Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
- What is being tested?
- DA-001, Phenylephrine and DA-001 Topical + DA-005 Oral (HIF-1α supplement)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 26 Apr 2027
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Diagnosed with telogen effluvium
- Willing and able to apply the treatment as directed, comply with study
- Otherwise healthy
- Able to give informed consent
Who cannot join
- A medical history that may interfere with study objectives
- Women who are pregnant, lactating, or planning to become pregnant during the study period
- Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
- Subjects who have known allergies to any excipient in DA-001
- Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
- Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
- Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
- Subject is unable to provide consent or make the allotted clinical visits
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth
Read the detailed description
DA-001 is a topical alpha 1 agonist combined with a TAAR receptor agonist. DA-001 was studied in a population of women that suffer from excessive hair shedding. DA-001 demonstrated significant reduction in hair shedding.
This study aims to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth.
- Conditions
- Telogen Effluvium, Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia, Male Pattern Baldness, Androgenetic Alopecia, Androgenetic Alopecia (AGA)
- Being tested
- DA-001, Placebo, Phenylephrine, DA-001 Topical + DA-005 Oral (HIF-1α supplement), DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)
- Keywords
- Hair Shedding, hair growth
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-001Drug
Phenylephrine 2.5% Topical + TAAR Agonist (GRAS) Topical Solution
PlaceboOther
Placebo Topical Solution
PhenylephrineDrug
Phenylephrine 2.5% Topical
DA-001 Topical + DA-005 Oral (HIF-1α supplement)Other
DA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement)
DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)Other
Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)
Phenylephrine Topical 0.25% + Intact Pro TopicalDrug
Phenylephrine 0.25% + Intact Pro (50% stronger)
Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)Other
Phenylephrine 0.25% + Intact Pro (50% stronger) + DA-005 Oral (HIF-1α supplement)
| Study group | Role | What they receive |
|---|---|---|
| DA-001 Topical | Experimental | Phenylephrine 2.5% Topical + TAAR agonist Receives: Drug: DA-001 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| Phenylephrine Topical | Experimental | Phenylephrine 2.5% Topical (per application volume - males 5mL and females 20mL) Receives: Drug: Phenylephrine |
| DA-001 Topical + DA-005 Oral (HIF-1α supplement) | Experimental | DA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement) Receives: Other: DA-001 Topical + DA-005 Oral (HIF-1α supplement) |
| DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement) | Experimental | Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement) Receives: Other: DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement) |
| Phenylephrine Topical 0.25% + Intact Pro Topical | Experimental | Phenylephrine Topical 0.25% + Intact Pro Topical Receives: Drug: Phenylephrine Topical 0.25% + Intact Pro Topical |
| Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement) | Experimental | Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement) Receives: Other: Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Hair Shedding
Number of hairs shedding during brushing at target area
Measured: Minutes [0,5]
Secondary outcomes (2)
Mean Change in Hair Shedding
Number of hairs shedding during brushing at target area
Measured: Week [0, 4, 12, 24]
Mean Change in Target Area Hair Count (TAHC)
Number of hairs in a 1-cm² target scalp area
Measured: Week [0, 4, 12, 24]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 May 2026 (estimated)
- Primary completion19 Mar 2027 (estimated)
- Study completion26 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telogen EffluviumStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Follea International Limited, Daniel Alain, Inc.
- Responsible party
- Sponsor
- Investigators
- Andy Goren, MD, Study director, University of Rome G. Marconi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648850
- Sponsor's protocol ID
- DA-001-TE
- Status last verified
- Apr 2026
- First submitted
- 17 Oct 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth
- ClinicalTrials.gov ID
- NCT06648850
- Acronym / sponsor ID
- DA-001-TE
- Conditions
- Telogen Effluvium, Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia, Male Pattern Baldness, Androgenetic Alopecia, Androgenetic Alopecia (AGA)
- Keywords
- Hair Shedding, hair growth
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Follea International Limited, Daniel Alain, Inc.
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 19 Mar 2027 (estimated)
- Study completion
- 26 Apr 2027 (estimated)
- First posted
- 18 Oct 2024 (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.
The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth
Detailed description
DA-001 is a topical alpha 1 agonist combined with a TAAR receptor agonist. DA-001 was studied in a population of women that suffer from excessive hair shedding. DA-001 demonstrated significant reduction in hair shedding.
This study aims to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| DA-001 Topical | Experimental | Drug: DA-001Phenylephrine 2.5% Topical + TAAR agonist |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| Phenylephrine Topical | Experimental | Drug: PhenylephrinePhenylephrine 2.5% Topical (per application volume - males 5mL and females 20mL) |
| DA-001 Topical + DA-005 Oral (HIF-1α supplement) | Experimental | Other: DA-001 Topical + DA-005 Oral (HIF-1α supplement)DA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement) |
| DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement) | Experimental | Other: DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement) |
| Phenylephrine Topical 0.25% + Intact Pro Topical | Experimental | Drug: Phenylephrine Topical 0.25% + Intact Pro TopicalPhenylephrine Topical 0.25% + Intact Pro Topical |
| Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement) | Experimental | Other: Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Diagnosed with telogen effluvium
- Willing and able to apply the treatment as directed, comply with study
- Otherwise healthy
- Able to give informed consent
Key exclusion criteria (8 listed)
- A medical history that may interfere with study objectives
- Women who are pregnant, lactating, or planning to become pregnant during the study period
- Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
- Subjects who have known allergies to any excipient in DA-001
- Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
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-001Phenylephrine 2.5% Topical + TAAR Agonist (GRAS) Topical Solution | Drug | DA-001 Topical |
| PlaceboPlacebo Topical Solution | Other | Placebo |
| PhenylephrinePhenylephrine 2.5% Topical | Drug | Phenylephrine Topical |
| DA-001 Topical + DA-005 Oral (HIF-1α supplement)DA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement) | Other | DA-001 Topical + DA-005 Oral (HIF-1α supplement) |
| DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement) | Other | DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement) |
| Phenylephrine Topical 0.25% + Intact Pro TopicalPhenylephrine 0.25% + Intact Pro (50% stronger) | Drug | Phenylephrine Topical 0.25% + Intact Pro Topical |
| Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)Phenylephrine 0.25% + Intact Pro (50% stronger) + DA-005 Oral (HIF-1α supplement) | Other | Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement) |
Primary outcome
Mean Change in Hair Shedding
Time frame: Minutes [0,5]
Number of hairs shedding during brushing at target area
2 secondary outcomes
Mean Change in Hair Shedding
Time frame: Week [0, 4, 12, 24]
Mean Change in Target Area Hair Count (TAHC)
Time frame: Week [0, 4, 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 13 Apr 2026.
- Daniel Alain, Inc. - Updated Study InformationLink provided by the sponsor.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing DA-001, Phenylephrine and DA-001 Topical + DA-005 Oral (HIF-1α supplement) in people with Telogen Effluvium and Female Pattern Hair Loss, run by Applied Biology, Inc..
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 8 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean Change in Hair Shedding (time frame: Minutes [0,5]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.