Status:

COMPLETED

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

Lead Sponsor:

Novartis

Conditions:

Atopic Dermatitis

Eligibility:

All Genders

18-60 years

Phase:

PHASE4

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT00367393

Start Date

March 1 2006

End Date

December 1 2007

Last Update

February 24 2017

Active Locations (1)

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Novartis

Novartis, Germany