NCT00838708

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

13 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

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 30, 2009

Status Verified

October 1, 2009

Enrollment Period

6 months

First QC Date

February 5, 2009

Last Update Submit

October 29, 2009

Conditions

Pruritus, Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Measure of intensity and duration of itch episodes

    Duration of episode

Secondary Outcomes (1)

  • Safety and local dermal tolerability

    4 weeks

Study Arms (2)

Vehicle cream

PLACEBO COMPARATOR
Other: vehicle cream

SRD174 Cream

EXPERIMENTAL
Drug: SRD174 Cream

Interventions

SRD174 CreamDRUG

topical SRD174 Cream

SRD174 Cream
vehicle creamOTHER

topical vehicle cream

Vehicle cream

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Hot Springs, Arkansas, United States

Location

Unknown Facility

Oceanside, California, United States

Location

Unknown Facility

Ormond Beach, Florida, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Grand Blanc, Michigan, United States

Location

Unknown Facility

High Point, North Carolina, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Hazleton, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Lynchburg, Virginia, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

MeSH Terms

Conditions

PruritusDermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 6, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

October 30, 2009

Record last verified: 2009-10

Locations

US(13)