Pruritus, Atopic DermatitisPhase 2NCT00838708
Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus
A Phase 2 study testing SRD174 Cream in people with Pruritus, Atopic Dermatitis, run by Serentis Ltd. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus, Atopic Dermatitis
- What is being tested?
- SRD174 Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 13 sitesUnited States
- Study dates
- Jan 2009to Aug 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Birmingham, Alabama
Study site
Dallas, Texas
Study site
Detroit, Michigan
Study site
Grand Blanc, Michigan
Study site
Hazleton, Pennsylvania
Study site
High Point, North Carolina
Study site
Hot Springs, Arkansas
Study site
Lynchburg, Virginia
Study site
Oceanside, California
Study site
Ormond Beach, Florida
Study site
Philadelphia, Pennsylvania
Study site
Spokane, Washington
Study site
Winston-Salem, North Carolina
About this study
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.
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.
- Conditions
- Pruritus, Atopic Dermatitis
- Being tested
- SRD174 Cream, vehicle cream
- Medical subject headings
- Pruritus, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRD174 CreamDrug
topical SRD174 Cream
vehicle creamOther
topical vehicle cream
| Study group | Role | What they receive |
|---|---|---|
| Vehicle cream | Placebo comparator | Not described Receives: Other: vehicle cream |
| SRD174 Cream | Experimental | Not described Receives: Drug: SRD174 Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of intensity and duration of itch episodes
Measured: Duration of episode
Secondary outcomes (1)
Safety and local dermal tolerability
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pruritus, Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serentis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838708
- Sponsor's protocol ID
- P174954201CD
- Status last verified
- Oct 2009
- First submitted
- 5 Feb 2009
- Last updated
- 30 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00838708
- Acronym / sponsor ID
- P174954201CD
- Conditions
- Pruritus, Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Serentis Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vehicle cream | Placebo comparator | Other: vehicle cream |
| SRD174 Cream | Experimental | Drug: SRD174 Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRD174 Creamtopical SRD174 Cream | Drug | SRD174 Cream |
| vehicle creamtopical vehicle cream | Other | Vehicle cream |
Primary outcome
Measure of intensity and duration of itch episodes
Time frame: Duration of episode
1 secondary outcome
Safety and local dermal tolerability
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SRD174 Cream in people with Pruritus, Atopic Dermatitis, run by Serentis Ltd. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of intensity and duration of itch episodes (time frame: Duration of episode). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2009.