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Aldara

Phase 3FDA approved

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

Aldara development status

FDA approval on record Mar 2, 2004
Approval holderBausch
ApplicationNDA020723
Highest phase Phase 3
Registered trials 3 across 3 sponsors since Nov 2008

Aldara target and mechanism

ModalitySmall molecule

Also known as Aldara (Imiquimod)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Aldara clinical trials

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 KeratosisUnlock trial analytics

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?

Aldara is used for the treatment of actinic keratosis, a skin condition involving rough, scaly lesions caused by sun damage. It is a small molecule therapy in the dermatology therapeutic area. Aldara is also known by the name imiquimod.

Who makes Aldara?

Aldara is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the development of Aldara for actinic keratosis.

What phase is Aldara in?

Aldara is in Phase 3 clinical development for actinic keratosis. It has been studied in one completed Phase 3 trial. As a Phase 3 asset, it remains investigational and is not approved for this indication based on the available development information.

What clinical trials is Aldara in?

Aldara has been evaluated in a completed Phase 3 trial, NCT00294320, titled Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions. The trial enrolled 12 participants in France, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.

Is Aldara the same as imiquimod?

Yes, Aldara is also known as imiquimod. Imiquimod is the generic or alternative name for the same small molecule therapy developed by Viatris Inc. for actinic keratosis.