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Not yet recruiting NCT06501924

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

Phase III Interventional Androgenetic Alopecia Female Pattern Baldness 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-005, Topical minoxidil 5%, DA-002, Placebo Oral Tablet.
Who it may be relevant to
Registry conditions: Androgenetic Alopecia, Female Pattern Baldness, 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 →

Overview

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).

Interventions

  • Dietary supplement DA-005
    Oral Botanical Supplement HIF-1a inhibitor
  • Drug Topical minoxidil 5%
    Topical minoxidil 5%
  • Drug DA-002
    Topical Alpha 1 Agonist (GRAS)
  • Dietary supplement Placebo Oral Tablet
    Placebo Oral Tablet
  • Other Placebo Topical Solution
    Placebo Topical Solution

Primary outcome measures

  • Target Area Hair Counts [Time frame: Week [0,12]]
  • Target Area Hair Counts [Time frame: Week [0,24]]

Eligibility criteria

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

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: NCT06501924 · DA-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗