Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease

NCT00507832 | Completed Phase 2 DMC

• 1 other identifier: SST-Pr-2-2005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The development of the topical calcineurin inhibitor pimecrolimus resulted in a significant improvement in the treatment of atopic dermatitis. In addition, an excellent amelioration of pruritus could be regularly observed. Up to now, several itchy dermatoses such as chronic irritative hand dermatitis, rosacea, graft-versus-host-disease, lichen sclerosus, prurigo simplex, scrotal eczema, and inverse psoriasis were reported as single cases also to respond to a pimecrolimus treatment. In prurigo nodularis, pruritus is the main symptom and it is of immediate importance to find an effective antipruritic therapy. Pruritus is regularly severe and therapy refractory to topical steroids or systemic antihistamines. Capsaicin cream is one effective possibility to reduce the itch in these diseases. However, it has to be applied 3 to 6 times daily, rubs off on the clothing and induces burning in erosions. In addition, since no commercial preparation is available, it has to be prescribed in several concentrations. The application of pimecrolimus seems to be promising since it has to be applied twice daily only. Especially in prurigo nodularis we expect a good response as we could demonstrate in single patients. Furthermore it has been published recently that Tacrolimus, another calcineurin inhibitor has been successfully used in the treatment of six patients with prurigo nodularis. This study is designed to compare the efficacy and safety of pimecrolimus 1% cream and hydrocortisone 1% cream in prurigo nodularis and to investigate the mode of action of the antipruritic effect of the drugs.

Conditions

Prurigo Nodularis

Keywords

Prurigo nodularis

Outcome Measures

Primary Outcomes (1)

• Hypothesis: pimecrolimus is superior in the reduction of the itch intensity on a visual analogue scale (VAS) compared to hydrocortisone cream 1%. H1: mean value VAS pimecrolimus < mean value VAS hydrocortisone

  12 months

Secondary Outcomes (2)

• Improvement of total symptom score (papule, nodules, excoriations, crusting, erythema) scored from 0-3 for each single symptom

  12 months

• Change of skin neuropeptide content in suction blisters

  12 months

Study Arms (2)

I

ACTIVE COMPARATOR

Interindividual design: active and comparator (one side each) applied twice daily

Drug: Pimecrolimus

II Hydrocortisone

ACTIVE COMPARATOR

Hydrocortisone, twice daily

Drug: Hydrocortisone

Interventions

Pimecrolimus DRUG

twice daily topical

Also known as: Elidel Cream 1%

I

Hydrocortisone DRUG

twice daily topical

Also known as: Hydrocortisone HExal

II Hydrocortisone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 - 70 years
• Diagnosis: Prurigo nodularis
• Pruritus intensity above VAS 3 (Visual analoge scale 0 to 10)
• Nodules on arms and legs (target areas: arms)
• No effective current external or internal antipruritic medication
• Signed informed consent

You may not qualify if:

• prurigo nodularis with massive excoriations and/or local infections
• atopic dermatitis, predisposition for atopic dermatitis
• Itch intensity below VAS 4 (visual analoge scale 0 to 10)
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Pregnancy should be ruled out before stating the study by a b-subunit HCG test.
• Females of childbearing potential and not practicing a medically approved, highly effective (low failure rate) method of contraception during and up to at least 4 weeks after the end of treatment. 'Medically approved' contraception may include implants, injectables, combined oral contraceptives, some IUDs (e.g. intrauterine device), sexual abstinence or if the woman has a vasectomized partner.
• active psychosomatic and psychiatric diseases
• History of active malignancy of any organ system
• actual diseases which need therapy and may induce pruritus (e.g. deficiency of iron, zinc)
• Systemic immunosuppression
• Topical use of tacrolimus, pimecrolimus, steroids or capsaicin within 2 weeks prior to study entry
• current and past (within 2 weeks prior to study entry) systemic use of antihistamines, steroids, cyclosporin A and other immunosuppressants, paroxetin, fluvoxamine (selective serotonin reuptake- inhibitors, study possible in case of medication since 6 months due to depression without having any Antipruritic effect) naltrexone and UV-therapy.
• wound healing disturbances, disposition for keloids, current medication which leads to increased bleeding during procedure e.g. acetylsalicylic acid (ASS), marcumar (no suction blister possible)
• History of hypersensitivity to pimecrolimus 1% cream or hydrocortisone 1% cream
• Participation in other clinical studies within the last 4 weeks

Sponsors & Collaborators

• University Hospital Muenster: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Department of Dermtology, University of Münster

Münster, 48149, Germany

Location

Related Publications (3)

• Stander S, Stander H, Seeliger S, Luger TA, Steinhoff M. Topical pimecrolimus and tacrolimus transiently induce neuropeptide release and mast cell degranulation in murine skin. Br J Dermatol. 2007 May;156(5):1020-6. doi: 10.1111/j.1365-2133.2007.07813.x. Epub 2007 Mar 28.

  PMID: 17388925 BACKGROUND

• Stander S, Luger TA. [Antipruritic effects of pimecrolimus and tacrolimus]. Hautarzt. 2003 May;54(5):413-7. doi: 10.1007/s00105-003-0521-6. Epub 2003 Mar 21. German.

  PMID: 12719860 BACKGROUND

• Senba E, Katanosaka K, Yajima H, Mizumura K. The immunosuppressant FK506 activates capsaicin- and bradykinin-sensitive DRG neurons and cutaneous C-fibers. Neurosci Res. 2004 Nov;50(3):257-62. doi: 10.1016/j.neures.2004.07.005.

  PMID: 15488288 BACKGROUND

MeSH Terms

Interventions

pimecrolimus; Hydrocortisone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Thomas A Luger, MD

  Department of Dermatology, University of Münster, Von-Esmarch-Str. 58, D-48149 Münster, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 27, 2007
• Study Start: April 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 7, 2010

Record last verified: 2009-02

Locations

DE (1)