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

Applied Biology

Status and phase: Begins enrollment this month; Phase 3; Phase 2

Conditions: Female Pattern Hair Loss; Telogen Effluvium; Female Pattern Hair Loss, Androgenic Alopecia

Treatments: Other: Placebo; Other: DA-001 Topical + DA-005 Oral (HIF-1α supplement); Drug: DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement); Drug: Phenylephrine; Drug: DA-001

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06648850

DA-001-TE

Details and patient eligibility

About

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

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 5 patient groups, including a placebo group

DA-001 Topical

Experimental group

Description:

Phenylephrine 2.5% Topical + TAAR agonist

Treatment:

Drug: DA-001

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

Phenylephrine Topical

Experimental group

Description:

Phenylephrine 2.5% Topical

Treatment:

Drug: Phenylephrine

DA-001 Topical + DA-005 Oral (HIF-1α supplement)

Experimental group

Description:

DA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement)

Treatment:

Other: DA-001 Topical + DA-005 Oral (HIF-1α supplement)

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

Experimental group

Description:

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

Treatment:

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