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Aldara

Phase 3

Actinic Keratosis | Small molecule | Dermatology |Viatris Inc.|Last Updated: Feb 7, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Aldara · 1 trial · 1 indication

Phase 3 1
NCT00294320Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis LesionsActinic Keratosis
COMPLETED12 Analytics
PHASE3COMPLETED
Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions
Actinic Keratosis
NCT0029432012
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Study Endpoints

Primary Endpoints

To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts.
8 weeks after the end of treatment

Secondary Endpoints

To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.
8 weeks after the end of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL250mg of Imiquimod cream application once daily 3 times per week.
2PLACEBO_COMPARATOR250mg vehicle cream for application once daily 3 times per week.

Interventions

NameTypeDescription
Aldara (Imiquimod)DRUG250mg of Imiquimod cream for application once daily 3 times per week.
Vehicle creamOTHER250mg vehicle cream for application once daily 3 times per week.
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Eligibility Criteria

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

Inclusion Criteria: * At least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions * Free of any significant findings (e.g tattoos) in the potential application site area. * Willing to discontinue sun-tanning and use of sunbed/sun parlour use * Willing to stop use...

Countries:France
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Frequently asked questions about Aldara

What is Aldara used for in Actinic Keratosis?

Aldara is a small molecule drug used for the treatment of Actinic Keratosis, a skin condition characterized by rough, scaly patches on the skin caused by sun damage. It is being developed by Viatris Inc. and is currently in Phase 3 clinical development.

Who makes Aldara?

Aldara is developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker symbol VTRS. The drug is being investigated for the treatment of Actinic Keratosis and is currently in Phase 3 clinical trials.

What phase is Aldara in?

Aldara is in Phase 3 clinical development for the treatment of Actinic Keratosis. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed to evaluate its efficacy and safety.

What clinical trials is Aldara in?

Aldara has one completed Phase 3 clinical trial, identified by the NCT number NCT00294320. This trial, titled 'Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions,' enrolled 12 participants in France and was a randomized, double-blind, placebo-controlled study.

Is Aldara the same as imiquimod?

Aldara is a brand name for the drug imiquimod, which is a small molecule used topically to treat actinic keratosis. The clinical trial data provided for Aldara includes a Phase 3 study that evaluated non-invasive techniques to monitor lesion clearance in patients with actinic keratosis.