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Elidel

Phase 2

Seborrheic Dermatitis | Small molecule | Dermatology |Novartis AG|Last Updated: Mar 14, 2022

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment113

FDA Designations

No designations recorded

Clinical trial landscape

Elidel · 1 trial · 1 indication

Phase 2 1
NCT00403559A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic DermatitisSeborrheic Dermatitis
COMPLETED113 Analytics
PHASE2COMPLETED
A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Seborrheic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.
One week from Baseline

F-IGA is defined as Facial Investigator's Global Assessment, which incorporates assessments of the severity of facial seborrheic dermatitis. Scoring is 0 to 3, 0 describing a better outcome with progressively worsening up to 3 representing a worse outcome (whole number only). 0 = Clear; 1 = Mild; 2 = Moderate and 3 = Severe. Scoring is based upon morphologic description of signs of erythema (0 =none, 1= faint, 2 =dull, 3 =deep/dark red) and scaling (0 = none, 1 = minute, powdery scale, 2 = thin flakes of scale, 3 = scales covering most of the involved areas).

Secondary Endpoints

Key Secondary Efficacy Will be the % of Patients With Facial Clearance
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Elidel Cream (pimecrolimus)EXPERIMENTALElidel Cream to be applied twice daily for 4 weeks
Ketoconazole Cream (Nizoral)ACTIVE_COMPARATORKetoconazole Cream to be applied twice daily for 4 weeks

Interventions

NameTypeDescription
ElidelDRUG -
Ketoconazole CreamDRUG -
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Eligibility Criteria

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

Inclusion Criteria: * Must be 18 or older and sign written informed consent. * Must be wiling and able to comply with protocol. * Must have active seborrheic dermatitis of the face. Exclusion Criteria: * No history of overt bacterial, viral or fungal infection of the head/neck. * No history or pr...

Countries:United States
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Frequently asked questions about Elidel

What is Elidel used for in Seborrheic Dermatitis?

Elidel is a small molecule being studied for the treatment of Seborrheic Dermatitis, a common skin condition. It is currently in Phase 2 clinical development and is not yet approved for this indication. The drug is being investigated as a topical treatment to address the symptoms of this dermatological condition.

Who makes Elidel?

Elidel is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical research to evaluate the safety and efficacy of Elidel for the treatment of Seborrheic Dermatitis.

What phase is Elidel in?

Elidel is in Phase 2 clinical development for the treatment of Seborrheic Dermatitis. It is an investigational drug and has not received regulatory approval for this use. The Phase 2 trial has been completed, with results expected to inform further development decisions.

What clinical trials is Elidel in?

Elidel has one completed Phase 2 clinical trial registered under NCT00403559, titled "A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis." The trial enrolled 113 participants in the United States, was randomized and double-blind, and used an active control.

Is Elidel the same as Pimecrolimus?

Elidel is also known as Pimecrolimus, as indicated in the clinical trial title. The drug is being investigated under the brand name Elidel for Seborrheic Dermatitis, and Pimecrolimus is the active pharmaceutical ingredient being studied in this Phase 2 trial.