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

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

Conditions

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

Interventions

DRUG

DA-001

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

OTHER

Placebo

Placebo Topical Solution

DRUG

Phenylephrine

Phenylephrine 2.5% Topical

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)

OTHER

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

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

DRUG

Phenylephrine Topical 0.25% + Intact Pro Topical

Phenylephrine 0.25% + Intact Pro (50% stronger)

OTHER

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

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

Sponsors & Collaborators

• Follea International Limited

  collaborator INDUSTRY

• Daniel Alain, Inc.

  collaborator INDUSTRY

• Applied Biology, Inc.

  lead INDUSTRY

Principal Investigators

• Andy Goren, MD · University of Rome G. Marconi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2027-03-19

Completion

2027-04-26