Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882245
• Other study ID #: P441201CD
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2009
• Last updated: October 29, 2009
• Start date: April 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Serentis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Vehicle ointment
Topical vehicle cream

Drug:
• Ointment
SRD441 Ointment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Serentis Ltd.

Countries where clinical trial is conducted

Bulgaria,  Finland,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure efficacy in treating acute exacerbations		4 weeks	No
Secondary	Safety and local dermal tolerability		4 weeks	Yes