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Not yet recruiting NCT06648850

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

Phase II / Phase III Interventional Telogen Effluvium Female Pattern Hair Loss Female Pattern Hair Loss, Androgenic Alopecia Male Pattern Baldness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DA-001, Placebo, Phenylephrine, DA-001 Topical + DA-005 Oral (HIF-1α supplement).
Who it may be relevant to
Registry conditions: Telogen Effluvium, Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia, Male Pattern Baldness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Mean Change in Hair Shedding [Time frame: Minutes [0,5]]
Secondary outcome measures (2)
  • Mean Change in Hair Shedding [Time frame: Week [0, 4, 12, 24]]
  • Mean Change in Target Area Hair Count (TAHC) [Time frame: Week [0, 4, 12, 24]]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06648850 · DA-001-TE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗