Clinical trial NCT00882245: Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Serentis Ltd.
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Measure efficacy in treating acute exacerbations
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety and local dermal tolerability
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Helsinki
country: Finland
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Cologne
country: Germany
city: Frankfurt
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Kiel
country: Germany
city: Munich
country: Germany
city: Munster
country: Germany
Study officials:
affiliation: Serentis Ltd.
name: Robert Tansley
role: STUDY_DIRECTOR
References:
citation: Foelster Holst R, Reitamo S, Yankova R, Worm M, Kadurina M, Thaci D, Bieber T, Tsankov N, Enk A, Luger T, Duffy M, Tansley R. The novel protease inhibitor SRD441 ointment is not effective in the treatment of adult subjects with atopic dermatitis: results of a randomized, vehicle-controlled study. Allergy. 2010 Dec;65(12):1594-9. doi: 10.1111/j.1398-9995.2010.02417.x. Epub 2010 Sep 7.