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Imiquimod

Phase 3

Carcinoma, Basal Cell | Small molecule | Oncology |Viatris Inc.|Last Updated: Feb 22, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment111

FDA Designations

No designations recorded

Clinical trial landscape

Imiquimod · 2 trials · 2 indications

Phase 3 2
NCT00189280Aldara for the Treatment of Large and/or Multiple sBCCCarcinoma, Basal Cell
COMPLETED111 Analytics
NCT00189241A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell CarcinomaBasal Cell Carcinoma
COMPLETED160 Analytics
PHASE3COMPLETED
Aldara for the Treatment of Large and/or Multiple sBCC
Carcinoma, Basal Cell
NCT00189280111
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PHASE3COMPLETED
A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma
Basal Cell Carcinoma
NCT00189241160
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Study Endpoints

Primary Endpoints

Clinical clearance of sBCC
12 or 16 weeks after treatment
To evaluate the long-term sustained clearance rate, defined as the proportion of subjects who are clinically clear of sBCC at the treated sBCC target tumour site at the 12 week posttreatment visit and remain clear during the 5 year follow-up period.

Secondary Endpoints

Reduction in size of tumour
12 or 16 weeks after treatment
Rate of clearance, Cosmetic outcome
12 or 16 weeks after treatment
Sustained clearance rate over 3 year follow-up
3 years after treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
imiqimod 5% creamEXPERIMENTAL -

Interventions

NameTypeDescription
ImiquimodDRUGcream 5%, 5 days out of seven, for 6 weeks
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Eligibility Criteria

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

Inclusion Criteria: * One or more sBCC on torso, neck or face * Total surface area \<= 40 sq cm Exclusion Criteria: * Pregnancy or women who are breastfeeding * Xeroderma pigmentosum, albinism, epidermodysplasia verruciformis, any genetic anomaly accompanied by skin tumors * Metatypical, adnexal,...

Countries:FranceGermany
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Frequently asked questions about Imiquimod

What is Imiquimod used for?

Imiquimod is a small molecule drug being developed by Viatris Inc. for the treatment of basal cell carcinoma and actinic keratosis. It is an investigational therapy that has been studied in clinical trials for these skin conditions.

What does Imiquimod target?

Imiquimod is a small molecule drug that works through immune response modulation. It is being studied for its effectiveness in treating superficial basal cell carcinoma and actinic keratosis, particularly in organ transplant recipients.

Who makes Imiquimod?

Imiquimod is being developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol VTRS. The company is conducting clinical trials to evaluate the drug's effectiveness in treating certain skin conditions.

What phase is Imiquimod in?

Imiquimod is in Phase 3 clinical development for basal cell carcinoma. It has completed Phase 3 trials, including a study evaluating the effectiveness of Imiquimod 5% cream in superficial basal cell carcinoma with 160 participants.

What clinical trials is Imiquimod in?

Imiquimod has been studied in several completed clinical trials. NCT00189241 was a Phase 3 trial in Germany for basal cell carcinoma with 160 participants. NCT00189267 was a Phase 2 trial for actinic keratosis in organ transplant recipients. NCT00189280 was a Phase 3 trial in France for basal cell carcinoma.

Is Imiquimod the same as Aldara?

Imiquimod is also known as Aldara, as indicated by the clinical trial NCT00189280 titled 'Aldara for the Treatment of Large and/or Multiple sBCC'. This trial evaluated the drug for the treatment of superficial basal cell carcinoma.