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CHG

Phase 1

Surgery | Small molecule | Other |Medline Inc.|Last Updated: Apr 30, 2021

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
RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02530554Pilot Trial of Chlorhexidine Gluconate (CHG) Preoperative Skin PreparationPHASE1 COMPLETED 14Jul 1, 2015Aug 1, 2015Sep 28, 2020 -
NCT02530528Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin PreparationPHASE1 COMPLETED 27Feb 1, 2014Apr 1, 2014Apr 30, 2021 -
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Study Endpoints
Primary Endpoints
Log Change in Bacterial Flora on Abdomen and Groin
10 min, 6 hr and 8 hr

Change was calculated as the baseline time point minus the later time points over an 8 hour period.

Log Reduction of Bacterial Flora on Abdomen and Groin Sites
10 min, 6 hr and 8 hr

Evaluate the Log Reduction of Normal Flora at various sites and timepoints

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CHG ClothEXPERIMENTAL3 min application time
Comparator CHGACTIVE_COMPARATORMarketed 2% CHG
2% CHG 1 minEXPERIMENTALsingle administration, 1 min application time
2% CHG 2 minEXPERIMENTALsingle administration, 2 min application time
2% CHG 3 minEXPERIMENTALsingle administration, 3 min application time
Comparator 2% CHGACTIVE_COMPARATORSingle administration, Marketed CHG
Interventions
NameTypeDescription
CHGDRUGSingle application
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy * No dermatological conditions Exclusion Criteria: * Sensitivity to CHG * Sensitivity to natural latex rubber or adhesive skin products

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