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

StatusNot Yet Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Start date: Feb 16, 2026 to May 1, 2026v10 Show 5 more changesShow less
    • Enrollment increased: 800 → 1120 participants
    • Study completion pushed from Mar 26, 2027 to Apr 26, 2027
    • Trial arms changed: 5 → 7
    • Primary completion date: Feb 19, 2027 to Mar 19, 2027
    • Interventions: DA-001 (Drug), DA-001 Topical + DA-005 Oral (HIF-1α supplement) (Other), DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α… to DA-001 (Drug), DA-001 Topical + DA-005 Oral (HIF-1α supplement) (Other), DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α…
  2. Start date: Jan 5, 2026 to Feb 16, 2026
    • Enrollment target: 600 to 800
    • Primary completion date: Dec 5, 2026 to Feb 19, 2027
    • Study completion date: Dec 31, 2026 to Mar 26, 2027
    v9
  3. Phase: Phase 3 to Phase 2/3v8 Show 10 more changesShow less
    • Primary completion date: Feb 16, 2026 to Dec 5, 2026
    • Start date: Oct 1, 2025 to Jan 5, 2026
    • Primary endpoint revised
    • Enrollment target: 480 to 600
    • Study completion date: Apr 17, 2026 to Dec 31, 2026
    • Interventions: DA-001 (Drug), Intact5 (Other), Phenylephrine (Drug), Placebo (Other) to DA-001 (Drug), DA-001 Topical + DA-005 Oral (HIF-1α supplement) (Other), DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α…
    • Secondary endpoints: 1 to 2
    • Study arms: 4 to 5
    • Study description expanded, about 4 words
    • Study title expanded, about 4 words
  4. Primary completion date: Jun 16, 2025 to Feb 16, 2026
    • Start date: Feb 15, 2025 to Oct 1, 2025
    • Study completion date: Aug 1, 2025 to Apr 17, 2026
    v7
  5. Start date: Jan 15, 2025 to Feb 15, 2025
    • Primary completion date: May 16, 2025 to Jun 16, 2025
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study description expanded, about 1 wordv5
  2. Enrollment target: 360 to 480
    • Interventions: DA-001 (Drug), Phenylephrine (Drug), Placebo (Other) to DA-001 (Drug), Intact5 (Other), Phenylephrine (Drug), Placebo (Other)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study arms: 3 to 4
    v4
  3. Enrollment target: 240 to 360v3 Show 5 more changesShow less
    • Start date: Nov 15, 2024 to Jan 15, 2025
    • Primary completion date: Mar 28, 2025 to May 16, 2025
    • Study completion date: May 16, 2025 to Aug 1, 2025
    • Interventions: DA-001 (Drug), Placebo Topical Solution (Other) to DA-001 (Drug), Phenylephrine (Drug), Placebo (Other)
    • Study arms: 2 to 3
  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06648850
Lead Sponsor Applied Biology, Inc.
Collaborators: Follea International Limited, Daniel Alain, Inc.
Conditions
(from sponsor)		 Telogen Effluvium, Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia, Male Pattern Baldness, Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Related terms Alopecia
Enrollment 1,120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov