Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007214

Trial Description

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Title

A Phase I, Multi-Centre, Randomised, Vehicle-Controlled, Double-Blinded, Explorative Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis Over a Treatment Period of Three Weeks

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to validate a left-right design with respect to detecting a
difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle
in adults with mild to moderate atopic dermatitis

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007214
  •   2015/05/08
  •   2014/03/26
  •   no
  •   [---]*
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Secondary IDs

  •   NCT02103725  (ClinicalTrials.gov)
  •   EXP-1092  (LEO Pharma)
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Health Condition or Problem studied

  •   Atopic Dermatitis
  •   L20 -  Atopic dermatitis
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Interventions/Observational Groups

  •   Drug: pimecrolimus 10 mg/g cream
  •   Drug: Vehicle cream
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   [---]*
  •   Parallel
  •   I
  •   [---]*
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Primary Outcome

- Evaluation of the treatment effect defined as total sign score on the treated area at end of the 3 weeks treatment period; time frame: 3 weeks

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Secondary Outcome

- Incidence of adverse events during the 3 weeks treatment period; time frame: 3 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2014/04/30
  •   30
  •   [---]*
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- 1. Male and female subjects, 18 years or older

- 2. Subject with atopic dermatitis with mild to moderate disease severity

- 3. Two symmetrical and comparable atopic dermatitis treatment areas

- 4. Female volunteers of childbearing potential must either be surgically sterile or
agree to use a reliable method of contraception

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Exclusion Criteria

- 1. Any condition in the target areas that in the opinion of the investigator could
interfere with clinical assessments, e.g. acne, infection, rash other than atopic
dermatitis, sunburn, hyper- or hypopigmentation, scars

- 2. Dark-skinned persons whose skin colour prevents reliable clinical assessments

- 3. Any permanent (or transient within 28 days prior to dosing) disease that may
interfere with the subjects safe participation in the trial, with the subjects
ability to participate in the trial or with the clinical assessments

- 4. Pregnancy or breastfeeding

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Addresses

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    • LEO Pharma
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    •   [---]*
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.