NCT00882245

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 30, 2009

Status Verified

October 1, 2009

Enrollment Period

4 months

First QC Date

April 15, 2009

Last Update Submit

October 29, 2009

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Measure efficacy in treating acute exacerbations

    4 weeks

Secondary Outcomes (1)

  • Safety and local dermal tolerability

    4 weeks

Study Arms (2)

Vehicle ointment

PLACEBO COMPARATOR
Other: Vehicle ointment

SRD441 Ointment

EXPERIMENTAL
Drug: Ointment

Interventions

Vehicle ointmentOTHER

Topical vehicle cream

Vehicle ointment
OintmentDRUG

SRD441 Ointment

SRD441 Ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Plovdiv, Bulgaria

Location

Unknown Facility

Sofia, Bulgaria

Location

Unknown Facility

Helsinki, Finland

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Munich, Germany

Location

Unknown Facility

Münster, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21039597DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Ointments

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Robert Tansley

    Serentis Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 15, 2009

First Posted

April 16, 2009

Study Start

April 1, 2009

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

October 30, 2009

Record last verified: 2009-10

Locations

BU(2)FI(1)DE(9)