Elidel (Pimecrolimus) - Summary

ELIDEL SUMMARY

Elidel

Elidel® (pimecrolimus) Cream 1% contains the compound pimecrolimus, the 33-epi-chloro-derivative of the macrolactam ascomycin.

Elidel® (pimecrolimus) Cream 1% is indicated for short-term and intermittent long-term therapy in the treat-ment of mild to moderate atopic dermatitis in non-immunocompromised patients 2 years of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies (see DOSAGE AND ADMINISTRATION).

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NEWS HIGHLIGHTS

Media Articles Related to Elidel (Pimecrolimus)

Atopic Dermatitis
Source: MedicineNet mupirocin Specialty [2008.06.03]
Title: Atopic Dermatitis
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 6/3/2008

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Published Studies Related to Elidel (Pimecrolimus)

A prospective randomized trial of topical pimecrolimus for cetuximab-associated acnelike eruption. [2009.10]
BACKGROUND: Clinical trials addressing the acneiform rash associated with epidermal growth factor receptor inhibitors are lacking. OBJECTIVE: We evaluated the ability of topical pimecrolimus to reduce the severity of cetuximab-related facial rash... CONCLUSIONS: Pimecrolimus application did not translate into clinically meaningful benefit for patients with cetuximab-related facial rash.

Different effects of pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis. [2009.09]
BACKGROUND: Genetic defects leading to skin barrier dysfunction were recognized as risk factors for atopic dermatitis (AD). It is essential that drugs applied to patients with AD restore the impaired epidermal barrier to prevent sensitization by environmental allergens. OBJECTIVES: We investigated the effect of 2 common treatments, a calcineurin inhibitor and a corticosteroid, on the skin barrier... CONCLUSION: The present study demonstrates that both betamethasone and pimecrolimus improve clinical and biophysical parameters and epidermal differentiation. Because pimecrolimus improved the epidermal barrier and did not cause atrophy, it might be more suitable for long-term treatment of AD.

Effects of pimecrolimus cream 1% in the treatment of patients with atopic dermatitis who demonstrate a clinical insensitivity to topical corticosteroids: a randomized, multicentre vehicle-controlled trial. [2009.08]
BACKGROUND: Colonization with Staphylococcus aureus in atopic dermatitis (AD) is often associated with worsening of clinical symptoms. Staphylococcus aureus produces superantigens that contribute to cutaneous inflammation and corticosteroid (CS) resistance. OBJECTIVES: To investigate the relationship between CS insensitivity, S. aureus colonization and superantigen production in AD, and to explore the efficacy of pimecrolimus cream in CS-insensitive AD... CONCLUSIONS: In a cohort of patients with clinical insensitivity to CS there was a significant positive correlation between S. aureus and disease severity. Results suggest that for some of these patients, treatment with pimecrolimus cream 1% is useful, especially in the head/neck area.

Different effects of pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis. [2009.05]
BACKGROUND: Genetic defects leading to skin barrier dysfunction were recognized as risk factors for atopic dermatitis (AD). It is essential that drugs applied to patients with AD restore the impaired epidermal barrier to prevent sensitization by environmental allergens. OBJECTIVES: We investigated the effect of 2 common treatments, a calcineurin inhibitor and a corticosteroid, on the skin barrier... CONCLUSION: The present study demonstrates that both betamethasone and pimecrolimus improve clinical and biophysical parameters and epidermal differentiation. Because pimecrolimus improved the epidermal barrier and did not cause atrophy, it might be more suitable for long-term treatment of AD.

The GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) trial. [2009.03]
OBJECTIVES: The aim of this study was to compare, in a randomized multicenter trial, paclitaxel-eluting stents (CoStar, Conor Medsystems, Menlo Park, California) versus pimecrolimus-eluting stents (Corio, Conor Medsystems) versus stents with dual elution of both drugs (SymBio, Conor Medsystems) in native coronary arteries. BACKGROUND: The CoStar cobalt-chromium reservoir-based stent platform, eluting paclitaxel in a controlled way via a bioresorbable polymer, reduces restenosis versus its respective bare-metal stent. The reservoir system allows the use of other drugs targeted to different mechanisms involved in the process of vascular restenosis and simultaneous loading of multiple, synergistic drugs... CONCLUSIONS: Stents eluting pimecrolimus or the dual combination of pimecrolimus and paclitaxel failed to show angiographic noninferiority when compared with paclitaxel-eluting stents. (A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems; NCT00322569).

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Clinical Trials Related to Elidel (Pimecrolimus)

Safety Study of Elidel (Pimecrolimus) 1% Cream to Treat Netherton Syndrome [Completed]
Netherton syndrome is a genetic condition that can result in abnormal skin functioning. People with this condition often have red and scaling skin; sparse or short hair; and problems with absorption of medicines or chemicals that are applied to the skin. If these chemicals are absorbed at a high level, they may cause health problems. Elidel (pimecrolimus) is a new medicine that is available as a cream. It has been shown to help improve the appearance of the skin in patients with another skin condition known as atopic dermatitis, and is approved by the United States (US) Food and Drug Administration for use in children with mild to moderate atopic dermatitis. The purpose of this study is to determine if Elidel is safe, to see whether the medication is absorbed through the skin, and to see if side effects are associated with its use in children with Netherton syndrome.

A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis [Completed]
A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis

Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects [Completed]
This study is not being conducted in the United States.

To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b. i.d.) versus once daily (o. d.) in preventing the progression to disease "relapse".

Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis [Completed]
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.

Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting [Completed]
An open-label, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic dermatitis in a daily practice

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PATIENT REVIEWS / RATINGS / COMMENTS

Elidel review by 37 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		hypothryoid-related dry skin
Dosage & duration:		once every 12 hours (dosage frequency: twice a day) for the period of five years
Other conditions:		hypothyroidism
Other drugs taken:		thyroid medication
		Reported Results
Benefits:		Elidel reduced my dry skin by about 80-85%. It increased exfoliation, which is very slowed down in hypothyroid-related dry skin, got rid of many of the blocked pores due to poor exfoliation, and stopped the vast majority of the flaking, burning, and redness I had suffered from before I used it.
Side effects:		The first week I used Elidel I got some flu-like symptoms, as warned on the package insert. It stands to reason that Elidel would make one very sun-sensitive, as it shuts down the skin's immune system; I didn't have a problem with this, as I always wore sunscreen, but it made me nervous. As I understand it, Elidel isn't formulated to help the skin help itself; instead it just shuts off the skin's erroneous response. For some skin conditions, this is sufficient, but it wasn't for me.
Comments:		After washing my face with gentle cleanser, I applied a small amount of Elidel to my entire face, before following up with a moisturizer (or two), then sunscreen.

Elidel review by 22 year old male patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Eczema
Dosage & duration:		Cream Form (dosage frequency: 2 times a day) for the period of 2 weeks
Other conditions:		Allergies
Other drugs taken:		No other drugs
		Reported Results
Benefits:		Decreased eczema patches, however did not fully heal them. The treatment did not help my skin being scaly from eczema.
Side effects:		There were no noticeable side effects.
Comments:		The treatment consisted of 2 times a day of applying the cream into the face for eczema. Pimecrolimus came in cream form so it would rub off easily.

Elidel review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		atopic dernatitis
Dosage & duration:		1% cream twice daily as needed (dosage frequency: twice a day as prescribed) for the period of two weeks
Other conditions:		cold sores sometimes on the lips and under the nose
Other drugs taken:		none
		Reported Results
Benefits:		No benefits, only very bad side effects (see below)
Side effects:		redness, tingling, headache, skin lesions and cold sores developing in the place of application
Comments:		Once I applied it for my dermatitis (the doc. prescribed it to me because she said it was non-steroidal), there was redness and tinging on the side of the application, which I thought was a normal side affect that should go away on its own. I kept applying it diligently as prescribed. In c couple of days there was a rash on the area ( I called the doctor about it and she said to stop using it for a couple of days and then apply it , since that might have a been a normal side effect). I did what she told me to, so I reapplied the drug again in a couple of days, there was redness and irritation and then later on the following day I had a cold sore developing on the spot (the affected area where I was applying the cream was the upper lip and the noso-labial folds). Plus to everything else I had a bad a headache, which as I found later could have been the side effect of that medication. I went to another dermatologist and she said that she would have never prescribed that medication for the face especially if I have a tendency to develop cold sores because that medication serves as a immunosuppressant.