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PEP005

Phase 3

Actinic Keratosis | Small molecule | Dermatology |IQVIA Holdings, Inc.|Last Updated: Apr 15, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

PEP005 · 1 trial · 1 indication

Phase 3 1
NCT00917306A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)Actinic Keratosis
COMPLETED102 Analytics
PHASE3COMPLETED
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
Actinic Keratosis
NCT00917306102
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Study Endpoints

Primary Endpoints

Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
57 days

Secondary Endpoints

Efficacy (complete and partial clearance of AK lesions)
57 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PEP005 gelEXPERIMENTALPEP005 gel, 0.05% administered once daily for 2 consecutive days

Interventions

NameTypeDescription
PEP005 GelDRUG0.05% two day treatment
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Patient is male or female and at least 18 years of age. * Female patient must be of either: * Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus) * Childbearing potential, provided ther...

Countries:United StatesAustralia
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