Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis

October 29, 2009 updated by: Serentis Ltd.

A Phase II, Double-Blind, Vehicle Controlled Study to Determine the Efficacy, Safety and Toleration of SRD441 Ointment in Patients With Atopic Dermatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle ointment
Other: Vehicle ointment
Topical vehicle cream
Experimental: SRD441 Ointment
Drug: Ointment
SRD441 Ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure efficacy in treating acute exacerbations
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and local dermal tolerability
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serentis Ltd.

Investigators

  • Study Director: Robert Tansley, Serentis Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

April 15, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (Estimate)

April 16, 2009

Study Record Updates

Last Update Posted (Estimate)

October 30, 2009

Last Update Submitted That Met QC Criteria

October 29, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P441201CD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis

Clinical Trials on Vehicle ointment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe