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Pimecrolimus 1%

Phase 3

Chronic Hand Dermatitis | Small molecule | Dermatology |Novartis AG|Last Updated: Feb 15, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment652

FDA Designations

No designations recorded

Clinical trial landscape

Pimecrolimus 1% · 1 trial · 1 indication

Phase 3 1
NCT00226707Pimecrolimus Cream 1% in Patients (18 Years of Age and Over) With Mild to Moderate Chronic Hand DermatitisChronic Hand Dermatitis
COMPLETED652 Analytics
PHASE3COMPLETED
Pimecrolimus Cream 1% in Patients (18 Years of Age and Over) With Mild to Moderate Chronic Hand Dermatitis
Chronic Hand DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Investigators Global Assessment (IGA) of the target hand at day 43 or at time of early discontinuation.

Secondary Endpoints

IGA of the non-target hand
Itching/burning assessment for the target and non-target hand
Non-key signs of hand dermatitis (vesiculation, oozing/crusts, edema/population, lichenification) at each study visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Pimecrolimus Cream 1%DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * \- Patients who are outpatients at baseline (Day 1) * Patients must be 18 years of age or above * Patients must have chronic hand dermatitis based upon clinical diagnosis with mild to moderate dermatitis of the target hand at baseline, as defined by an Investigator's Global As...

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Frequently asked questions about Pimecrolimus 1%

What is Pimecrolimus used for?

Pimecrolimus is a small molecule being developed by Novartis AG for dermatological conditions. It is studied for Lichen Sclerosus, Perioral Dermatitis, Chronic Hand Dermatitis, Keratoconjunctivitis Sicca, and Atopic Dermatitis. Clinical trials have evaluated it in forms such as a cream and an ophthalmic suspension.

Who makes Pimecrolimus?

Pimecrolimus is developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is a small molecule in the dermatology therapeutic area, with completed clinical trials across multiple indications.

What phase is Pimecrolimus in?

Pimecrolimus is in Phase 3 clinical development. It has completed Phase 3 trials for Chronic Hand Dermatitis and Atopic Dermatitis, and Phase 2 trials for Keratoconjunctivitis Sicca and Lichen Sclerosus. It remains investigational and is not approved for these uses.

What clinical trials is Pimecrolimus in?

Pimecrolimus has completed several clinical trials. NCT00226707 studied the cream in Chronic Hand Dermatitis, NCT00231998 was an extension study in pediatric Atopic Dermatitis, NCT00128245 tested an ophthalmic suspension in Keratoconjunctivitis Sicca, and NCT00393263 compared it to clobetasol in vulvar Lichen Sclerosus.

Is Pimecrolimus the same as Elidel?

Pimecrolimus is the active ingredient in Elidel, a brand name for the 1% cream used to treat atopic dermatitis. The clinical trials listed include studies of pimecrolimus cream in various dermatological conditions, and the drug is also being investigated in other formulations.