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Not yet recruitingNCT06648850Updated Apr 13, 2026

Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth

A Phase 2/3 interventional study of DA-001 and Placebo in Telogen Effluvium, Female Pattern Hair Loss and Female Pattern Hair Loss, Androgenic Alopecia, sponsored by Applied Biology, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Applied Biology, Inc. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
1,120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Telogen Effluvium
  • Female Pattern Hair Loss
  • Female Pattern Hair Loss, Androgenic Alopecia
  • Male Pattern Baldness
  • Androgenetic Alopecia
  • Androgenetic Alopecia (AGA)

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Keywords

  • Hair Shedding
  • hair growth
03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 1,120 is above the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Applied Biology, Inc. is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
  • Subjects who have known allergies to any in DA-001
  • Subjects who are currently participating in another clinical study or have completed another clinical study with an 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,120 participants (estimated)

Study arms

  • Experimental
    DA-001 Topical

    Phenylephrine 2.5% Topical + TAAR agonist

    Drug: DA-001

  • Placebo comparator
    Placebo

    Placebo

    Other: Placebo

  • Experimental
    Phenylephrine Topical

    Phenylephrine 2.5% Topical (per application volume - males 5mL and females 20mL)

    Drug: Phenylephrine

  • Experimental
    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)

  • Experimental
    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)

  • Experimental
    Phenylephrine Topical 0.25% + Intact Pro Topical

    Phenylephrine Topical 0.25% + Intact Pro Topical

    Drug: Phenylephrine Topical 0.25% + Intact Pro Topical

  • Experimental
    Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)

    Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)

    Other: Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)

Interventions

  • DrugDA-001

    Phenylephrine 2.5% Topical + TAAR Agonist (GRAS) Topical Solution

  • OtherPlacebo

    Placebo Topical Solution

  • Phenylephrine 2.5% Topical

  • OtherDA-001 Topical + DA-005 Oral (HIF-1α supplement)

    DA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement)

  • OtherDA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)

    Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)

  • DrugPhenylephrine Topical 0.25% + Intact Pro Topical

    Phenylephrine 0.25% + Intact Pro (50% stronger)

  • OtherPhenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)

    Phenylephrine 0.25% + Intact Pro (50% stronger) + DA-005 Oral (HIF-1α supplement)

06

What researchers measure

Primary outcomes

  1. Mean Change in Hair Shedding

    Number of hairs shedding during brushing at target area

    Time frame: Minutes [0,5]

Secondary outcomes

  1. Mean Change in Hair Shedding

    Number of hairs shedding during brushing at target area

    Time frame: Week [0, 4, 12, 24]

  2. Mean Change in Target Area Hair Count (TAHC)

    Number of hairs in a 1-cm² target scalp area

    Time frame: Week [0, 4, 12, 24]

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06648850
Collaborators
Follea International Limited, Daniel Alain, Inc.
Responsible party
Sponsor
First posted
Oct 18, 2024
Start date
May 1, 2026 (estimated)
Primary completion
Mar 19, 2027 (estimated)
Completion
Apr 26, 2027 (estimated)
Last update
Apr 13, 2026

Study contacts

Andy Goren, MD
Contact
clinicalstudies@appliedbiology.com
16507040850
Andy Goren, MD
study director · University of Rome G. Marconi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Phenylephrine

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