Recent Updates
Recently added Catalysts

PluroGel

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

PluroGel · 1 trial · 1 indication

Phase 1 1
NCT05000983A Between Patient Study of Plurogel® Compared to Standard Topical Dressing in Burn InjuriesBurns
RECRUITING25 Analytics
PHASE1RECRUITING
A Between Patient Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries
BurnsUnlock trial analytics

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
Unlock Study Endpoints

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).
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about PluroGel

What is PluroGel used for?

PluroGel is an investigational small molecule being developed for the treatment of burns. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied as a topical dressing for burn injuries.

Who makes PluroGel?

PluroGel is being developed by Medline Inc., a company traded under the ticker symbol MDLN. The company is conducting clinical research to evaluate the safety and efficacy of PluroGel for the treatment of burns.

What phase is PluroGel in?

PluroGel is currently in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The ongoing Phase 1 trial is actively recruiting participants to study the drug's effects in patients with burn injuries.

What clinical trials is PluroGel in?

PluroGel is being studied in a Phase 1 clinical trial with the identifier NCT05000983. This trial is titled 'A Between Patient Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries' and is currently recruiting participants in Canada.

Is PluroGel the same as Plurogel?

Yes, PluroGel and Plurogel refer to the same investigational drug. The clinical trial NCT05000983 uses the spelling 'Plurogel' in its title, while the drug name is commonly written as 'PluroGel'. Both names refer to the same product being developed by Medline Inc.