Atopic DermatitisPhase 1/2NCT00932074
A Study to Determine the Safety, Tolerability and Efficacy of KP-413 in Subjects With Atopic Dermatitis(AD)
A Phase 1/2 study testing KP-413 Ointment in people with Atopic Dermatitis, run by Kaken Pharmaceutical at 6 sites in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability and efficacy of KP-413 topical ointment compared with vehicle ointment in treating adult subjects with atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- KP-413 Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2009to Jun 2010
- Phase
- Phase 1/2
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has a clear diagnosis of AD meeting the Hanifin and Rajka criteria for AD that involves both the head/neck and the torso/limbs, and affects 5-30% of the subject's total BSA as determined using the rule of nines
- Has a Baseline IGSS of 3(moderate) or 4(severe) in the selected treatment area on the torso/limbs, and a Baseline IGSS of 2(mild), 3(moderate) or 4(severe) in the selected treatment area on the head/neck.
- Female of childbearing potential has a negative pregnancy test and will be using an effective method of contraception during the study.
Who cannot join
- Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Has a Baseline oozing/crusting score of 3(moderate) or greater at the selected treatment area on the head/neck or torso/limbs.
- Presence of a concurrent skin condition that could interfere with assessment of treatment.
- Treatment with any investigational drug or device within 30 days or 5 half lives(whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
DermResearch, Inc.
Austin, Texas, 78759
Michigan Center for Research Corp
Clinton Twp., Michigan, 48038
J & S Studies, Inc.
College Station, Texas, 77845
Dermatology Treatment & Research Center, PA
Dallas, Texas, 75230
The Education & Research Foundation, Inc
Lynchburg, Virginia, 24501-1604
Oregon Medical Research Center, PC
Portland, Oregon, 97223
About this study
Official title: A Phase 1/2 Study Evaluating the Safety, Tolerability and Efficacy of KP-413 Topical Ointment in Subjects With Atopic Dermatitis
The purpose of this study is to assess the safety, tolerability and efficacy of KP-413 topical ointment compared with vehicle ointment in treating adult subjects with atopic dermatitis (AD).
- Conditions
- Atopic Dermatitis
- Being tested
- KP-413 Ointment
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KP-413 OintmentDrug
Study drug ointment to be applied topically to the selected treatment areas on the head/neck and torso/limbs twice a day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 3% KP-413 Ointment | Experimental | Not described Receives: Drug: KP-413 Ointment |
| 1% KP-413 Ointment | Experimental | Not described Receives: Drug: KP-413 Ointment |
| Placebo | Placebo comparator | Not described Receives: Drug: KP-413 Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Severity Score(IGSS)
Measured: 4 weeks
Secondary outcomes (4)
Plasma levels of KP-413
Measured: 6 weeks
Signs and Symptoms of AD
Measured: 4 weeks
Subject's Numerical Rating Scale(NRS) of Pruritus Score
Measured: 4 weeks
Percent of AD-affected body surface area (BSA)
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 posted2 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaken Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dow Pharmaceutical Sciences
- Responsible party
- Sponsor
- Investigators
- Barry Calvarese, MS, Study director, Dow Pharmaceutical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932074
- Sponsor's protocol ID
- DPSI-KP413-P2-01
- Status last verified
- Apr 2012
- First submitted
- 30 Jun 2009
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study Evaluating the Safety, Tolerability and Efficacy of KP-413 Topical Ointment in Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00932074
- Acronym / sponsor ID
- DPSI-KP413-P2-01
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Kaken PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Dow Pharmaceutical Sciences
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Jul 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.
The purpose of this study is to assess the safety, tolerability and efficacy of KP-413 topical ointment compared with vehicle ointment in treating adult subjects with atopic dermatitis (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3% KP-413 Ointment | Experimental | Drug: KP-413 Ointment |
| 1% KP-413 Ointment | Experimental | Drug: KP-413 Ointment |
| Placebo | Placebo comparator | Drug: KP-413 Ointment |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Has a clear diagnosis of AD meeting the Hanifin and Rajka criteria for AD that involves both the head/neck and the torso/limbs, and affects 5-30% of the subject's total BSA as determined using the rule of nines
- Has a Baseline IGSS of 3(moderate) or 4(severe) in the selected treatment area on the torso/limbs, and a Baseline IGSS of 2(mild), 3(moderate) or 4(severe) in the selected treatment area on the head/neck.
- Female of childbearing potential has a negative pregnancy test and will be using an effective method of contraception during the study.
Key exclusion criteria (4 listed)
- Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Has a Baseline oozing/crusting score of 3(moderate) or greater at the selected treatment area on the head/neck or torso/limbs.
- Presence of a concurrent skin condition that could interfere with assessment of treatment.
- Treatment with any investigational drug or device within 30 days or 5 half lives(whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.
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 |
|---|---|---|
| KP-413 OintmentStudy drug ointment to be applied topically to the selected treatment areas on the head/neck and torso/limbs twice a day for 4 weeks. | Drug | 1% KP-413 Ointment, 3% KP-413 Ointment, Placebo |
Primary outcome
Investigator's Global Severity Score(IGSS)
Time frame: 4 weeks
4 secondary outcomes
Plasma levels of KP-413
Time frame: 6 weeks
Signs and Symptoms of AD
Time frame: 4 weeks
Subject's Numerical Rating Scale(NRS) of Pruritus Score
Time frame: 4 weeks
Percent of AD-affected body surface area (BSA)
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 6 Apr 2012.
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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.
Barry Calvarese, MS study director
Dow Pharmaceutical Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KP-413 Ointment in people with Atopic Dermatitis, run by Kaken Pharmaceutical at 6 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 4 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 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Investigator's Global Severity Score(IGSS) (time frame: 4 weeks). 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 6 Apr 2012.