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

NCT06648850
clinicaltrials.gov
Phase
Phase 2/Phase 3
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Recruitment status
Not yet recruiting
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Participants
1,120
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Lead sponsor
Applied Biology, Inc.
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Start date
2026-05-01
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Summary
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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Short title
Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth
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Official title
Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2027-04-26
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First posted
2024-10-18
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Registry last updated
2026-04-13
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Primary completion date
2027-03-19
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Start date
2026-05-01
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Participants
1,120
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Participant count basis
Estimated
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Planned participants
1,120
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Protocol amendments
7
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Applied Biology, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06648850
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ClinicalTrials.gov ID
NCT06648850
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Mean Change in Hair Shedding

    Timeframe: Minutes [0,5]

    Number of hairs shedding during brushing at target area

  1. Mean Change in Hair Shedding

    Timeframe: Week [0, 4, 12, 24]

    Number of hairs shedding during brushing at target area

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

    Timeframe: Week [0, 4, 12, 24]

    Number of hairs in a 1-cm² target scalp area

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (2)

Lead sponsors (1)

Conditions (4)

Targets (3)