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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Androgenetic Alopecia; Female Pattern Hair Loss; Male Pattern Baldness; Telogen Effluvium; Androgenetic Alopecia (AGA); Female Pattern Hair Loss, Androgenic Alopecia
• Intervention / Treatment: Other: Placebo; Drug: DA-001; Drug: Phenylephrine; Other: DA-001 Topical + DA-005 Oral (HIF-1α supplement); Other: DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement); Drug: Phenylephrine Topical 0.25% + Intact Pro Topical; Other: Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)

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 Type: Interventional
• Enrollment (Estimated): 1120
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Andy Goren, MD; Phone Number: 16507040850; Email: clinicalstudies@appliedbiology.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo Topical Solution
Experimental: DA-001 Topical; Phenylephrine 2.5% Topical + TAAR agonist	Drug: DA-001; Phenylephrine 2.5% Topical + TAAR Agonist (GRAS) Topical Solution
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); DA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + 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); Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)
Experimental: Phenylephrine Topical; Phenylephrine 2.5% Topical (per application volume - males 5mL and females 20mL)	Drug: Phenylephrine; Phenylephrine 2.5% Topical
Experimental: Phenylephrine Topical 0.25% + Intact Pro Topical	Drug: Phenylephrine Topical 0.25% + Intact Pro Topical; Phenylephrine 0.25% + Intact Pro (50% stronger)
Experimental: Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)	Other: Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement); Phenylephrine 0.25% + Intact Pro (50% stronger) + DA-005 Oral (HIF-1α supplement)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	Week [0, 4, 12, 24]

Collaborators and Investigators

• Sponsor: Applied Biology, Inc.
• Collaborators: Follea International Limited; Daniel Alain, Inc.
• Investigators: Study Director: Andy Goren, MD, University of Rome G. Marconi

Publications and helpful links

Helpful Links

• Daniel Alain, Inc. - Updated Study Information

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 19, 2027
• Study Completion (Estimated): April 26, 2027

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hair growth; Hair Shedding
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Organic Chemicals; Amines; Alcohols; Amino Alcohols; Ethanolamines; Phenylephrine
• Other Study ID Numbers: DA-001-TE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No