Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established
Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream.
- Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
- ELIDEL Cream is not indicated for use in children less than 2 years of age.
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).
Published Studies Related to Elidel (Pimecrolimus)
Pimecrolimus vs. tacrolimus for the topical treatment of unresponsive oral
erosive lichen planus: a 8 week randomized double-blind controlled study. 
CONCLUSION: Both medications would currently appear to be a treatment of choice
Bilateral comparison study of pimecrolimus cream 1% and a ceramide-hyaluronic acid emollient foam in the treatment of patients with atopic dermatitis. [2011.06]
Topical corticosteroids have been the mainstay of treatment for atopic dermatitis (AD) over the last decade, especially in the setting of acute flares. However, heavy and prolonged use of topical corticosteroid is undesirable as it is associated with side effects such as, skin atrophy, telangiectasia, striae, steroid-induced dermatoses, rosacea, acne exacerbation, and in some severe and rare cases, systemic effects such as hypothalamic-pituitary-adrenal axis suppression, growth retardation and ocular problems.
A double-blind, randomized controlled trial of clobetasol versus pimecrolimus in patients with vulvar lichen sclerosus. [2011.06]
BACKGROUND: Lichen sclerosus (LS) is a lymphocyte-mediated chronic cutaneous disorder with a predilection for the vulva. The current gold standard treatment is topical ultrapotent corticosteroids such as clobetasol. OBJECTIVE: We sought to compare the safety and efficacy of clobetasol and pimecrolimus in the treatment of vulvar LS... CONCLUSION: Both clobetasol and pimecrolimus appear efficacious and well tolerated for the treatment of vulvar LS; however, clobetasol is more effective than pimecrolimus and should remain first-line therapy for LS. Copyright (c) 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
Clinical and cytological effects of pimecrolimus cream 1% after resolution of active atopic dermatitis lesions by topical corticosteroids: a randomized controlled trial. [2011.02]
BACKGROUND: Topical pimecrolimus may maintain remissions of atopic dermatitis (AD) by inhibiting subclinical inflammation. OBJECTIVE: To evaluate clinical and cytological effects of pimecrolimus in topical corticosteroid-treated and resolved AD lesions... CONCLUSION: Topical pimecrolimus was effective at maintaining betamethasone-17alpha-valerate-induced AD remission by inhibiting recurrences of the inflammatory infiltrate in the skin. Copyright (c) 2010 S. Karger AG, Basel.
A bilateral comparison study of pimecrolimus cream 1% and a topical medical
device cream in the treatment of patients with atopic dermatitis. 
Corticosteroids are the mainstay of therapy for atopic dermatitis, but long-term
use is associated with adverse effects. We sought to evaluate the clinical
efficacy of two steroid-sparing creams for atopic dermatitis... In conclusion, a lipid-rich, non-steroidal, topical
medical device cream was as effective in improving atopic dermatitis as
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.
Bilateral Comparison Study of Elidel 1% and Hylatopic Plus Emollient Foam for the Treatment of Subjects With Atopic Dermatitis [Recruiting]
This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic
dermatitis. It is designed to assess and compare the efficacy of ElidelÂ® (pimecrolimus)
cream 1% and Hylatopicâ„˘ Plus Emollient Foamâ„˘ in subjects with atopic dermatitis. Subjects
will apply ElidelÂ® (pimecrolimus) cream 1% twice daily for four weeks on a chosen target
eczematous area located on one side of the body and then apply Hylatopicâ„˘ Plus Emollient
Foamâ„˘ three times daily on a symmetrical target eczematous area on the opposite side of the
body. A randomized list will be created to determine which side the subject applies each
Subjects will be consented prior to any study evaluations or procedures. After signing the
consent and meeting all inclusion/exclusion criteria, qualified and enrolled subjects will
apply study medication (ElidelĂ‚Â® and HylatopicĂ˘Â„Â˘ Plus Emollient FoamĂ˘Â„Â˘) to chosen affected
areas for four weeks. Photography will be used to record the location of target lesions at
the baseline, week two and week four/final visits. Subject's disease status will be
assessed by two methods: 1) Physician's Global Assessment (PGA) and 2) Target Lesion Symptom
Score (TLSS) (see sections V. B.2 and V. B.3). PGA as well as TLSS will be made at baseline
(Day 0), week two (Day 14 +/- 2 days) and week 4/final visit (Day 28 +/- 2days) visits for
each of the target lesions. Half scales (i. e. 0. 5, 1. 5) will not be used. The presence or
absence of skin atrophy and telangiectasias will be noted at each study visit as well.
Additionally, subjects' self-assessments of their perception of degree of disease and
itching severity control will be collected at each visit for each target lesion. This
assessment will be made using a four point scale and Itch Severity Scale (visual analogue
score) respectively (see section V. B.4). Lastly, subjects will take a Product Preference
Survey at week 4/final visit (Day 28 +/- 2days). Parents (or guardians) will moderate
Product Preference Surveys for subjects that are younger than 12 years of age.
Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema [Recruiting]
The purpose of this study is to determine the effect of topical pimecrolimus on the immune
system by assessing the levels of antimicrobial peptides in the skin of patients with
eczema. It is hypothesized that pimecrolimus applied topically will repair the body's
immune system in patients with eczema by increasing antimicrobial peptides.
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".
Reports of Suspected Elidel (Pimecrolimus) Side Effects
Hodgkin's Disease (15),
Neuropathy Peripheral (8),
Maternal Exposure During Pregnancy (8),
Anaemia (8), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 9 ratings/reviews, Elidel has an overall score of 6.67. The effectiveness score is 6.44 and the side effect score is 8.89. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Elidel review by 74 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || Idiopathic excema|
|Dosage & duration:|| || thin film (dosage frequency: twice/day) for the period of 6 years|
|Other conditions:|| || None|
|Other drugs taken:|| || None|
|Benefits:|| || Skin inflamation disappeared |
|Side effects:|| || None|
|Comments:|| || A thin film using a cotton swab applied over the region on the base of my neck.
I tiried at least four other prescription and even more over the counter topical meds and none of them helped. I would prefer not to use "elidel" because there are some warnings over its use. My MD told me to use only if nothing else works, and nothing else is of any help.|
Elidel review by 22 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Moderately Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || Eczema|
|Dosage & duration:|| || cream form (dosage frequency: 2 times a day) for the period of 2 weeks|
|Other conditions:|| || skin allergies|
|Other drugs taken:|| || none|
|Benefits:|| || Fast acting, did not have to worry about skin thinning|
|Side effects:|| || None that I noticed|
|Comments:|| || The treatment consisted of applying the cream form of Pimecrolimus twice a day on the face for eczema treatment. The cream itself wore off very fast which limited how effective it acted. However, benefits were seen within the first week of use.|
Elidel review by 36 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Ineffective|
|Side effects:|| || Severe Side Effects|
|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|
|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. |
Page last updated: 2014-11-30