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Diclofenac

Phase 3

Actinic Keratosis | Small molecule | Dermatology |Teva Pharmaceutical Industries Limited|Last Updated: May 5, 2017

Target and mechanism

ModalitySmall molecule

Also known as Diclofenac sodium

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment492

FDA Designations

No designations recorded

Clinical trial landscape

Diclofenac · 1 trial · 1 indication

Phase 3 1
NCT02611804A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald ScalpActinic Keratosis
COMPLETED492 Analytics
PHASE3COMPLETED
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp
Actinic Keratosis
NCT02611804492
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Study Endpoints

Primary Endpoints

Proportion of Patients with Treatment Success at Visit 4
Day 90
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Diclofenac Sodium Gel, 3%EXPERIMENTALDiclofenac Sodium Gel, 3%, applied twice daily for 60 days
Solaraze®ACTIVE_COMPARATORSolaraze® (diclofenac sodium) Gel, 3%, applied twice daily for 60 days
Vehicle of Test ProductPLACEBO_COMPARATORVehicle of Test Product, Gel, applied twice daily for 60 days

Interventions

NameTypeDescription
Diclofenac sodiumDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites30

Inclusion Criteria: * Willing and able to provide written informed consent for the study. * At least 18 years of age * Immunocompetent male or nonpregnant and nonlactating female. Each female subject of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at l...

Countries:United States
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