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NCT Number: NCT06648850

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-001

Drug

Phenylephrine 2.5% Topical + TAAR Agonist (GRAS) Topical Solution

Placebo

Other

Placebo Topical Solution

Phenylephrine

Drug

Phenylephrine 2.5% Topical

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

Other

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

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

Other

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

Phenylephrine Topical 0.25% + Intact Pro Topical

Drug

Phenylephrine 0.25% + Intact Pro (50% stronger)

Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)

Other

Phenylephrine 0.25% + Intact Pro (50% stronger) + DA-005 Oral (HIF-1α supplement)

Primary outcomes

  1. Mean Change in Hair Shedding

    Time frame: Minutes [0,5]

    Number of hairs shedding during brushing at target area

Secondary outcomes

  1. Mean Change in Hair Shedding

    Time frame: Week [0, 4, 12, 24]

    Number of hairs shedding during brushing at target area

  2. Mean Change in Target Area Hair Count (TAHC)

    Time frame: Week [0, 4, 12, 24]

    Number of hairs in a 1-cm² target scalp area

Study contacts

Contact information is provided by the study sponsor or research team.

Andy Goren, MD

CONTACT

[email protected]

16507040850

Sponsors and collaborators

Lead sponsor

Applied Biology, Inc.

Industry

Collaborators

  • Daniel Alain, Inc.
  • Follea International Limited

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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