Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients

Last updated: August 28, 2014
Sponsor: Astellas Pharma Inc
Overall Status: Completed

Phase

3

Condition

Atopic Dermatitis

Allergy

Dermatitis, Atopic

Treatment

N/A

Clinical Study ID

NCT00523952
FG-506-06-CEE-01
  • Ages > 16
  • All Genders

Study Summary

Objective: Assess efficacy and safety of tacrolimus ointment when used in adults with moderate or severe atopic dermatitis. The ointment was applied on the affected skin twice daily for 3 weeks and then once daily until all lesions were cleared

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, any ethnic group, age ≥16

  • Moderate to severe atopic dermatitis

  • Has given informed consent

Exclusion

Exclusion Criteria:

  • Erythroderma

  • Pregnant or breast-feeding

  • Skin infection on the affected area

Study Design

Total Participants: 303
Study Start date:
January 01, 2004
Estimated Completion Date:
September 30, 2005

Study Description

The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).

Connect with a study center

  • Brno,
    Czech Republic

    Site Not Available

  • Hradec Kralove,
    Czech Republic

    Site Not Available

  • Ostrava,
    Czech Republic

    Site Not Available

  • Plzen,
    Czech Republic

    Site Not Available

  • Prague,
    Czech Republic

    Site Not Available

  • Tabor,
    Czech Republic

    Site Not Available

  • Usti nad Labem,
    Czech Republic

    Site Not Available

  • Budapest,
    Hungary

    Site Not Available

  • Debrecen,
    Hungary

    Site Not Available

  • empty

    Györ,
    Hungary

    Site Not Available

  • Györ,
    Hungary

    Site Not Available

  • Kecskemet,
    Hungary

    Site Not Available

  • Miskolc,
    Hungary

    Site Not Available

  • Pecs,
    Hungary

    Site Not Available

  • Bialystok,
    Poland

    Site Not Available

  • Czestochowa,
    Poland

    Site Not Available

  • Gdansk,
    Poland

    Site Not Available

  • Katowice,
    Poland

    Site Not Available

  • Krakow,
    Poland

    Site Not Available

  • Lodz,
    Poland

    Site Not Available

  • Lublin,
    Poland

    Site Not Available

  • Poznan,
    Poland

    Site Not Available

  • Sopot,
    Poland

    Site Not Available

  • Szczecin,
    Poland

    Site Not Available

  • Warsaw,
    Poland

    Site Not Available

  • Wroclaw,
    Poland

    Site Not Available

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