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Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis

NCT ID: NCT00882245

Last Updated: 2009-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vehicle ointment

Group Type PLACEBO_COMPARATOR

Vehicle ointment

Intervention Type OTHER

Topical vehicle cream

SRD441 Ointment

Group Type EXPERIMENTAL

Ointment

Intervention Type DRUG

SRD441 Ointment

Interventions

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Vehicle ointment

Topical vehicle cream

Intervention Type OTHER

Ointment

SRD441 Ointment

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Serentis Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Serentis Ltd

Principal Investigators

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Robert Tansley

Role: STUDY_DIRECTOR

Serentis Ltd.

Locations

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Plovdiv, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Helsinki, , Finland

Site Status

Berlin, , Germany

Site Status

Bonn, , Germany

Site Status

Cologne, , Germany

Site Status

Frankfurt, , Germany

Site Status

Hanover, , Germany

Site Status

Heidelberg, , Germany

Site Status

Kiel, , Germany

Site Status

Munich, , Germany

Site Status

Münster, , Germany

Site Status

Countries

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Bulgaria Finland Germany

References

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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.

Reference Type DERIVED
PMID: 21039597 (View on PubMed)

Other Identifiers

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P441201CD

Identifier Type: -

Identifier Source: org_study_id