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

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06648850

Enrollment

1120

Registered

2024-10-18

Start date

2026-05-01

Completion date

2027-04-26

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Hair Shedding, hair growth

Brief 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

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.

Interventions

DRUGDA-001

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

OTHERPlacebo

Placebo Topical Solution

DRUGPhenylephrine

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 informed consent

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 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

Design outcomes

Primary

Measure	Time frame	Description
Mean Change in Hair Shedding	Minutes [0,5]	Number of hairs shedding during brushing at target area

Secondary

Measure	Time frame	Description
Mean Change in Hair Shedding	Week [0, 4, 12, 24]	Number of hairs shedding during brushing at target area
Mean Change in Target Area Hair Count (TAHC)	Week [0, 4, 12, 24]	Number of hairs in a 1-cm² target scalp area

Contacts

CONTACTAndy Goren, MD

clinicalstudies@appliedbiology.com16507040850

STUDY_DIRECTORAndy Goren, MD

University of Rome G. Marconi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026