Viewing Study NCT00838708


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Study NCT ID: NCT00838708
Status: COMPLETED
Last Update Posted: 2009-10-30
First Post: 2009-02-05
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus
Sponsor: Serentis Ltd.
Organization:

Study Overview

Official Title: A Phase II, Randomised, Double-blind, Vehicle-controlled, Cross-over Study to Determine the Anti-pruritic Efficacy, Safety and Local Dermal Toleration of SRD174 Cream in Subjects With Atopic Dermatitis.
Status: COMPLETED
Status Verified Date: 2009-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Pruritus is an essential feature for the diagnosis of atopic dermatitis and may play an important part in disease progression. Itching has a significant impact on the quality of life of AD sufferers, in particular night-time itching leading to sleep disturbance and subsequent poor daytime performance.

The objective of this study is to determine whether SRD174 Cream is a safe and effective therapy for moderate to severe pruritus associated with atopic dermatitis.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: