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Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT00367393
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : February 24, 2017
Sponsor:
Information provided by:
Novartis

Brief Summary:
Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Pimecrolimus cream 1% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Multicenter 12-month Long Term Study on Skin Reconstitution With Pimecrolimus Cream 1% in Adult Patients With Atopic Eczema and Corticosteroid Induced Skin Damage
Study Start Date : March 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 1
Pimecrolimus cream 1%
Drug: Pimecrolimus cream 1%
Pimecrolimus cream 1% bid, as needed
Other Name: ASM981




Primary Outcome Measures :
  1. • Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. • Epidermal thickness by optical coherence tomography at selected investigational centers [ Time Frame: 48 weeks ]
  2. Skin thickness by ultrasound at selected investigational centers [ Time Frame: 48 weeks ]
  3. Epidermal thickness by 3mm punch biopsies (optional) [ Time Frame: 48 weeks ]
  4. Skin metabolism by suction blisters. [ Time Frame: 48 weeks ]
  5. Investigator's Global Assessment (IGA) [ Time Frame: 48 weeks ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically diagnosed AD
  • almost clear to mild AD (local IGA [target lesions face and cubital areas] score of 1-3)
  • clinically (i.e. to the unaided eye) evident skin atrophy due to long-term topical steroid use
  • Dermatophot Score (DPS - composed of skin atrophy and telangiectasia) of 4-6 on at least two target areas

Exclusion Criteria:

  • Phototherapy or systemic therapy known or suspected to have an effect on AD within 4 weeks prior to study entry
  • Topical therapy known or suspected to have an effect on AD within 7 days prior to study entry or systemic corticosteroids within 4 weeks prior to study entry
  • Clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367393


Locations
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Germany
Novartis
Novartis, Germany
Sponsors and Collaborators
Novartis
Investigators
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Study Chair: Novartis Pharm Novartis

Additional Information:
Publications:
Reference: Thaci D et al TBD. CORTICOSTEROID-INDUCED SKIN DAMAGE IMPROVED WITH PIMECROLIMUS CREAM 1% TREATMENT: A 1-YEAR STUDY IN ADULTS WITH ATOPIC ECZEMA. European Academy of Dermatology and Venereology - 17th Congress. 2008; www.eadv.org

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Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00367393     History of Changes
Other Study ID Numbers: CASM981CDE20
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, eczema

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action