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A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of May 31, 2024 to Oct 16, 2024
    • Site details revised at 4 of 4 sites
    v7
  2. Study sites: 3 to 4
    • Eligibility criteria expanded, about 14 words
    • Study description expanded, about 62 words
    v6
  3. Primary completion date: Aug 31, 2023 to May 31, 2024v5 Show 5 more changesShow less
    • Enrollment target: 64 to 85
    • Study completion date: May 31, 2028 to May 31, 2029
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 3 of 10 entries
    • Study description expanded, about 59 words
  4. Trial status: Active, Not Recruiting to Recruitingv4 Show 7 more changesShow less
    • Primary completion date: Sep 21, 2022 to Aug 31, 2023
    • Enrollment target: 44 to 64
    • Study completion date: Jun 2027 to May 31, 2028
    • Eligibility criteria shortened, about 13 words
    • Secondary endpoints: 7 to 10
    • Study description expanded, about 79 words
    • Site details revised at 3 of 3 sites
  5. Primary completion date changed from estimate of Nov 2021 to Sep 21, 2022v3 Show 8 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 37 to confirmed 44
    • Study completion date: Jan 2022 to Jun 2027
    • Eligibility criteria expanded, about 103 words
    • Secondary endpoints: 5 to 7
    • Study description expanded, about 81 words
    • Site details revised at 3 of 3 sites
  6. Enrollment target: 22 to 37v2 Show 7 more changesShow less
    • Study sites: 1 to 3
    • Primary completion date: Sep 2021 to Nov 2021
    • Start date changed from estimate of Sep 2020 to Oct 7, 2020
    • Secondary endpoints: 4 to 5
    • Study description shortened, about 15 words
    • Eligibility criteria expanded, about 5 words
    • Study title expanded, about 5 words
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
Trial Details
NCT Number NCT04540900
Lead Sponsor Krystal Biotech, Inc.
Conditions
(from sponsor)		 Skin Roughness, Wrinkle, Fine Lines, Skin Thickness
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov