Clinical Study of DA-002 and DA-005 As a Treatment for Hair Loss

Phase 3

Not yet recruiting

• Conditions: Androgenetic Alopecia; Female Pattern Baldness; Male Pattern Baldness
• Interventions: Dietary Supplement: DA-005; Drug: Topical minoxidil 5%; Drug: DA-002; Other: Placebo Topical Solution; Dietary Supplement: Placebo Oral Tablet

• Registration Number: NCT06501924
• Lead Sponsor: Applied Biology, Inc.

Brief Summary

The primary objective of the study is to assess the safety and efficacy of DA-005 and DA-002 as a treatment for hair loss (androgenetic alopecia).

Detailed Description

DA-005 is a botanical supplement with demonstrated HIF-1a inhibitory action. The ingredients were tested in-vitro and have demonstrated the HIF-1a inhibitory effect. The primary aim of the study is to compare DA-005 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).

DA-002 is a topical alpha 1 agonist. The ingredients were tested in-vitro and have demonstrated hair growth effects. The secondary aim of the study is to compare DA-002 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-12
• Study First Posted: 2024-07-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Study Start: 2025-01-15
• Primary Completion: 2025-10-17
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

• Age 18 or older
• Diagnosed with androgenetic alopecia
• 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-002 or DA-005
• 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-005	DA-005	Oral Botanical Supplement HIF-1a inhibitor
DA-005	Placebo Topical Solution	Oral Botanical Supplement HIF-1a inhibitor
Topical Minoxidil 5%	Topical minoxidil 5%	Topical Minoxidil 5%
Topical Minoxidil 5%	Placebo Oral Tablet	Topical Minoxidil 5%
DA-002	DA-002	Topical Alpha 1 Agonist
DA-002	Placebo Oral Tablet	Topical Alpha 1 Agonist

Primary Outcome Measures

Name	Time	Method
Target Area Hair Counts	Week [0,24]	Target Area Hair Counts