NCT06648850

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

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,120 (estimated)
• Sponsor: Applied Biology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-03-19
• Completion: 2027-04-26
• First posted: 2024-10-18
• Last updated: 2026-04-13