Clinical Study of DA-001 as a Treatment for Hair Shedding... | NCT06648850

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

NCT06648850

Sponsor

Applied Biology, Inc.

Status

Not yet recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

1,120Estimated

Phase

Phase 2Phase 3

Conditions

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

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2026Estimated

Primary Completion Date

Mar 19, 2027Estimated

Completion Date

Apr 26, 2027Estimated

First Submitted Date

Oct 17, 2024

First Submission Date that Met QC Criteria

Oct 17, 2024

First Posted Date

Oct 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2026

Last Update Posted Date

Apr 13, 2026Actual

Name	Class
Follea International Limited	INDUSTRY
Daniel Alain, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DA-001 Topical	Experimental	Phenylephrine 2.5% Topical + TAAR agonist	Drug: DA-001
Placebo	Placebo Comparator	Placebo	Other: Placebo
Phenylephrine Topical	Experimental	Phenylephrine 2.5% Topical (per application volume - males 5mL and females 20mL)	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)	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)	Other: DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)
Phenylephrine Topical 0.25% + Intact Pro Topical	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-001	Drug	Phenylephrine 2.5% Topical + TAAR Agonist (GRAS) Topical Solution	DA-001 Topical

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Andy Goren, MD	Contact	16507040850		clinicalstudies@appliedbiology.com

Name	Affiliation	Role
Andy Goren, MD	University of Rome G. Marconi	Study Director

Label	URL
Daniel Alain, Inc. - Updated Study Information	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines