Clinical Study of DA-001 as a Treatment for Telogen Effluvium

Phase 3

Not yet recruiting

• Conditions: Telogen Effluvium
• Interventions: Drug: DA-001; Other: Placebo; Drug: Phenylephrine; Other: Intact5

• Registration Number: NCT06648850
• Lead Sponsor: Applied Biology, Inc.

Brief Summary

The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for telogen effluvium

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 telogen effluvium.

Study Timeline

• Study First Submitted: 2024-10-17
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Study Start: 2025-10-01
• Primary Completion: 2026-02-16
• Study Completion: 2026-04-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 480

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-001	DA-001	Phenylephrine + Alpha 1 Agonist + TAAR Agonist
Placebo	Placebo	Placebo
Phenylephrine	Phenylephrine	Phenylephrine
Intact5	Intact5	Cosmetic formulation containing bitter orange extract

Primary Outcome Measures

Name	Time	Method
Number of Hairs Shedding	Minutes [0,5]	Number of hairs shedding during brushing at target area

Secondary Outcome Measures

Name	Time	Method
Number of Hairs Shedding	Week [0,4]	Number of hairs shedding during brushing at target area