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Pimecrolimus

Phase 3

Atopic Dermatitis | Small molecule | Dermatology |Novartis AG|Last Updated: May 27, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment584

FDA Designations

No designations recorded

Clinical trial landscape

Pimecrolimus · 5 trials · 3 indications

Phase 3 4Phase 2 1
NCT00232115Pimecrolimus Cream 1% in Adult Patients With Perioral DermatitisPerioral Dermatitis
COMPLETED124 Analytics
NCT00231998Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic DermatitisAtopic Dermatitis
COMPLETED240 Analytics
NCT00232011Extension Study to Assess Safety and Efficacy of Pimecrolimus in Adult Patients With Atopic DermatitisAtopic Dermatitis
COMPLETED160 Analytics
NCT00351052Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic DermatitisAtopic Dermatitis
COMPLETED184 Analytics
PHASE3COMPLETED
Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
Perioral DermatitisUnlock trial analytics
PHASE3COMPLETED
Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis
Atopic DermatitisUnlock trial analytics
PHASE3COMPLETED
Extension Study to Assess Safety and Efficacy of Pimecrolimus in Adult Patients With Atopic Dermatitis
Atopic DermatitisUnlock trial analytics
PHASE3COMPLETED
Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Reduction of the Perioral Dermatitis Severity Index
Safety assessed by adverse events (AEs)
Corticoid-sparing effect of pimecrolimus cream 1%
12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom
change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)

Secondary Endpoints

Time to disease recurrence
Response rates
Patient's quality of life assessment
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPimecrolimus
2PLACEBO_COMPARATORVehicle
Pimecrolimus 0.3%EXPERIMENTALASM981 0.3%
Pimecrolimus 1%EXPERIMENTALASM981 1%
Vehicle with carbopolPLACEBO_COMPARATOR -
Vehicle without carbopolPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PimecrolimusDRUGPimecrolimus cream 1 %
PlaceboDRUGVehicle cream (placebo)
Pimecrolimus Cream 1%DRUGPimecrolimus cream 1 %
VehicleDRUGPlacebo
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Eligibility Criteria

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

Inclusion Criteria: * clinically diagnosed perioral dermatitis associated or not associated with topical steroid use (the periorbital area may also be involved in addition to the perioral region) * minimum severity score (PODSI) ≥ 4 * age 18 and older Exclusion Criteria: * Ongoing use of the foll...

Countries:GermanyJapanUnited States
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Frequently asked questions about Pimecrolimus

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.