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Imiquimod 3.75%

Phase 2

Actinic Keratosis | Small Molecules | Dermatology |Bausch Health Companies Inc.|Trials Updated: Jan 20, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Imiquimod 3.75% clinical trials

Imiquimod 3.75% · 1 trial · 1 indication

Phase 2 1
NCT03914417Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% CreamActinic Keratosis
COMPLETED21 Analytics
PHASE2COMPLETED
Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream
Actinic KeratosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Responders
Day 70

The number of participants with reduction in number of AKs on the face and/or scalp after application of imiquimod 3.75%.

Secondary Endpoints

Number of Treatment Related Adverse Events
Day 70
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Imiquimod 3.75% creamEXPERIMENTALapplied topically

Interventions

NameTypeDescription
Imiquimod 3.75% CreamDRUGApproximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen. Subjects were followed every 2 weeks during treatment (week 2, 4 and 6) and then at 4 and 8 weeks post last-imiquimod application (week 10 and 14).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adults at least 18 years old. * Subjects must be in good general health as confirmed by the medical history. * Subjects must be able to read, sign, and understand the informed consent. * Prior to imiquimod therapy, subjects must have at least 4-8 actinic keratoses on the face ...

Countries:United States
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