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

Applied Biology

Status and phase: Not yet enrolling; Phase 3

Conditions: Female Pattern Baldness; Male Pattern Baldness; Androgenetic Alopecia

Treatments: Dietary Supplement: DA-005; Other: Placebo Topical Solution; Drug: Topical minoxidil 5%; Dietary Supplement: Placebo Oral Tablet; Drug: DA-002

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06501924

DA-005

Details and patient eligibility

About

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).

Full 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).

Enrollment: 516 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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516 participants in 3 patient groups

DA-005

Experimental group

Description:

Oral Botanical Supplement HIF-1a inhibitor

Treatment:

Other: Placebo Topical Solution

Dietary Supplement: DA-005

Topical Minoxidil 5%

Active Comparator group

Description:

Topical Minoxidil 5%

Treatment:

Dietary Supplement: Placebo Oral Tablet

Drug: Topical minoxidil 5%

DA-002

Experimental group

Description:

Topical Alpha 1 Agonist

Treatment:

Drug: DA-002

Dietary Supplement: Placebo Oral Tablet