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Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Serentis Ltd.
ClinicalTrials.gov Identifier:
NCT00882245
First received: April 15, 2009
Last updated: October 29, 2009
Last verified: October 2009
History of Changes
  Purpose

Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large parts of the body. The exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. The objective of this study is to determine whether SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.


Condition Intervention Phase
Atopic Dermatitis
 Other: Vehicle ointment
Drug: Ointment
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Vehicle Controlled Study to Determine the Efficacy, Safety and Toleration of SRD441 Ointment in Patients With Atopic Dermatitis

Further study details as provided by Serentis Ltd.:

Primary Outcome Measures:
  • Measure efficacy in treating acute exacerbations [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and local dermal tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: April 2009
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle ointment Other: Vehicle ointment
Topical vehicle cream
Experimental: SRD441 Ointment Drug: Ointment
SRD441 Ointment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged 18 or over
  • Subjects with a history of AD
  • Written and dated informed consent
  • Satisfactory medical assessment with no clinical relevant abnormalities.

Exclusion Criteria:

  • Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
  • Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
  • Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study.
  • Subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882245

Locations
Bulgaria
Plovdiv, Bulgaria
Sofia, Bulgaria
Finland
Helsinki, Finland
Germany
Berlin, Germany
Bonn, Germany
Cologne, Germany
Frankfurt, Germany
Hannover, Germany
Heidelberg, Germany
Kiel, Germany
Munich, Germany
Munster, Germany
Sponsors and Collaborators
Serentis Ltd.
Investigators
Study Director: Robert Tansley Serentis Ltd.
  More Information

No publications provided by Serentis Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert Tansley, Chief Medical Officer, Serentis Ltd
ClinicalTrials.gov Identifier: NCT00882245     History of Changes
Other Study ID Numbers: P441201CD
Study First Received: April 15, 2009
Last Updated: October 29, 2009
Health Authority: Bulgaria: Bulgarian Drug Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013