Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus

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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00838708

Enrollment

Registered

2009-02-06

Start date

2009-01-31

Completion date

2009-08-31

Last updated

2009-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus, Atopic Dermatitis

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.

Interventions

DRUGSRD174 Cream

topical SRD174 Cream

OTHERvehicle cream

topical vehicle cream

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Males and females aged 18 years and over moderate to severe AD pruritus * Written signed and dated informed consent * Satisfactory medical assessment with no clinically relevant abnormalities

Exclusion criteria

* Subject with active and pruritic AD covering a body surface area (BSA) \> 20% * Subject with severe AD defined as an IGA score of 4 * Subject with current or recurrent skin disease (except AD) that could affect the site of application of action, absorption or disposition of the investigational product, or clinical, laboratory assessments. * Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study. * Subject with known or suspected intolerance or hypersensitivity to the Investigational products or any of the stated ingredients. * Subject who has a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with interpretation of trial results and, in the judgment if the investigator, would make the subject inappropriate for entry into this trial.

Design outcomes

Primary

Measure	Time frame
Measure of intensity and duration of itch episodes	Duration of episode

Secondary

Measure	Time frame
Safety and local dermal tolerability	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026