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Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01792713
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Spirig Pharma Ltd.

Brief Summary:
Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis

Condition or disease Intervention/treatment Phase
Skin Alterations Associated With Atopic Dermatitis Drug: Sertaconazole 2% cream Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomisierte, Doppelblinde, Plazebo-kontrollierte Prüfung Zum Nachweis Der Wirksamkeit Und Der Lokalen Verträglichkeit Einer 2%Igen Sertaconazol-Crème Bei Patienten Mit Atopischer Dermatitis (Abridged)
Study Start Date : February 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Sertaconazole 2% cream
2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up
Drug: Sertaconazole 2% cream
Placebo Comparator: Placebo Arm
2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up
Drug: Placebo



Primary Outcome Measures :
  1. Change in Patient Global Assessment (PGA) [ Time Frame: day 1, day 28 ]

Secondary Outcome Measures :
  1. Change in Eczema Area and Severity Index (EASI) [ Time Frame: day 1, day 28 ]
  2. Change in Dermatology Life Quality Index (DLQI) [ Time Frame: d1, d28 ]
  3. Change in Patient Benefit Index (PBI) [ Time Frame: day 1, day 28 ]

Other Outcome Measures:
  1. Change in Transepidermal water loss (TEWL) [ Time Frame: d1, d14, d28, d42 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Atopic Dermatitis Patients with SCORing Atopic Dermatitis (SCORAD) ≤ 40
  • Atopic lesion localisation: arms; additional legs, neck

Exclusion Criteria:

  • SCORAD > 40
  • Unstable, uncontrolled medical status (e.g. active systemic or topical infection)
  • Active immunosuppression or cancer
  • Narcotics- or Alcohol abuse
  • Participation in another clinical trial until one month prior inclusion
  • Known allergies against an ingredient of the investigational medicinal product
  • Different periods of grace for certain pre-treatments, e.g. topical corticosteroids, immune modulating drugs
  • Pregnancy or lactation

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): NCT01792713


Locations
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Germany
Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie
Berlin, Germany, 10117
Universitätsklinikum Münster, Klinik für Hautkrankheiten
Münster, Germany, 48149
Sponsors and Collaborators
Spirig Pharma Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Spirig Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01792713    
Other Study ID Numbers: E550-PRU-2012
2012-003954-95 ( EudraCT Number )
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015
Keywords provided by Spirig Pharma Ltd.:
Skin alterations
Atopic Dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sertaconazole
Antifungal Agents
Anti-Infective Agents