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PluroGel

Phase 1

Burns | Small molecule | Other |Medline Inc.|Last Updated: Dec 5, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05000983A Between Patient Study of Plurogel® Compared to Standard Topical Dressing in Burn InjuriesPHASE1 RECRUITING 25Oct 20, 2021Dec 31, 2027Dec 5, 20241 Canada
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Study Endpoints
Primary Endpoints
Primary outcome
1-14 days

Days to over 80% area of burn injury healed

Secondary Endpoints
Patient and caregiver satisfaction and perception of pain
At each dressing change
Proportion requiring surgery
1-14 days
Relative surface area skin grafted
1-14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Standard dressingACTIVE_COMPARATORTopical antibiotic ointment (Polysporin™ or formulary equivalent) and non-adherent petrolatum fine-meshed gauze (ADAPTIC™) applied every Monday, Wednesday and Friday (or equivalent).
Test dressingEXPERIMENTALA 0.5 cm layer of PluroGel® followed by the above standard dressing. In addition, this will be covered with moistened gauze, kept moist twice daily. (The additional factors are the use of PluroGel® and moistened gauze. Standard dressing will continue to be used.)
Interventions
NameTypeDescription
PluroGelDRUGA 0.5 cm layer of PluroGel® followed by the above standard dressing. In addition, this will be covered with moistened gauze, kept moist twice daily. (The additional factors are the use of PluroGel® and moistened gauze. Standard dressing will continue to be used.)
Standard dressingDRUGTopical antibiotic ointment (Polysporin™ or formulary equivalent) and non-adherent petrolatum fine-meshed gauze (ADAPTIC™) applied every Monday, Wednesday and Friday (or equivalent).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Persons with partial thickness face burns or unilateral limb burn injuries requiring admission. Exclusion Criteria: * Total burn surface area (TBSA) \>30%. * Burn depth full thickness or deeper on initial assessment. * Prior excision at another healthcare centre. * Patients ...

Countries:Canada
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05000983studyFirstPostDate: changed