Plaque PsoriasisPhase 1/2IDP-118NCT01670513
A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
A Phase 1/2 study testing IDP-118 Low Strength and IDP-118 High Strength in people with Plaque Psoriasis, run by Dow Pharmaceutical Sciences at 6 sites in United States.
Trial summary
Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- IDP-118 Low Strength and IDP-118 High Strength
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2012to Jul 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of any race, 18 to 65 (inclusive) years of age.
- Freely given verbal and written informed consent obtained from the subject.
- Clinical diagnosis of psoriasis at the Screening and Baseline visits with
- At least 10% - 20% of total treatable BSA involvement, and
- an Investigator's Global Evaluation score of 3 or 4 ( moderate or severe) on a scale of 0 to 5
- Good general health as determined by the Investigator based on the subject's medical history and physical examination, with Screening hematology, serum chemistry, and urinalysis laboratory values within normal range limits.
Who cannot join
- Presence of psoriasis that was previously treated with prescription medication prior to the Screening visit and is non-responsive to corticosteroid treatment, as determined by the Investigator.
- Presence of any concurrent skin condition that could interfere with the evaluation of the study drug, as determined by the Investigator.
- History of adrenal disease
- Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Dow Clinical Study Site
Austin, Texas, 78759
Dow Clinical Study Site
Clinton Township, Michigan, 48038
Dow Cliincal Study Site
Fort Gratiot, Michigan, 48059
Dow Clinical Study Site
Nashville, Tennessee, 37215
Dow Clinical Study Site
Norfolk, Virginia, 23507
Dow Clinical Study Site
Santa Rosa, California, 95403
About this study
Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.
Read the detailed description
Approximately 60 subjects with a clinical diagnosis of moderate or severe psoriasis (defined as at least of 10 % - 20% treatable Body Surface Area (BSA) and an Investigator's Global Evaluation (IGE) of 3 or 4 at baseline (moderate or severe) will be enrolled in the study.
- Conditions
- Plaque Psoriasis
- Being tested
- IDP-118 Low Strength, IDP-118 High Strength
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-118 Low StrengthDrug
Also called IDP-118
8 weeks
IDP-118 High StrengthDrug
Also called IDP-118
8 weeks
| Study group | Role | What they receive |
|---|---|---|
| IDP-118 Low Strength | Experimental | IDP-118 Low Strength Receives: Drug: IDP-118 Low Strength |
| IDP-118 High Strength | Experimental | IDP-118 High Strength Receives: Drug: IDP-118 High Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of HPA axis suppression after treatment with investigational drug product and the comparators
To measure the incidence of HPA axis suppression after treatment with investigational drug product and the comparators
Measured: 8 weeks
Secondary outcomes (1)
To evaluate the safety and cutaneous tolerability of the two formulations and the comparators
To evaluate and Local Skin Reactions: Tolerability will be evaluated through assessment of selected local signs and symptoms at the drug-application site: itching, dryness, burning and stinging. In addition the treatment areas will be examined at each visit for significant known drug-related AEs such as skin atrophy, striae, telangiectasia and folliculitis.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow Pharmaceutical Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Plott, MD, Study director, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670513
- Sponsor's protocol ID
- DPSI-IDP-118-P2-01
- Acronym
- IDP-118
- Status last verified
- Apr 2013
- First submitted
- 31 May 2012
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
- ClinicalTrials.gov ID
- NCT01670513
- Acronym / sponsor ID
- IDP-118 / DPSI-IDP-118-P2-01
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dow Pharmaceutical SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 22 Aug 2012 (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.
Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.
Detailed description
Approximately 60 subjects with a clinical diagnosis of moderate or severe psoriasis (defined as at least of 10 % - 20% treatable Body Surface Area (BSA) and an Investigator's Global Evaluation (IGE) of 3 or 4 at baseline (moderate or severe) will be enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDP-118 Low Strength | Experimental | Drug: IDP-118 Low StrengthIDP-118 Low Strength |
| IDP-118 High Strength | Experimental | Drug: IDP-118 High StrengthIDP-118 High Strength |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female of any race, 18 to 65 (inclusive) years of age.
- Freely given verbal and written informed consent obtained from the subject.
- Clinical diagnosis of psoriasis at the Screening and Baseline visits with
- At least 10% - 20% of total treatable BSA involvement, and
- an Investigator's Global Evaluation score of 3 or 4 ( moderate or severe) on a scale of 0 to 5
Key exclusion criteria (4 listed)
- Presence of psoriasis that was previously treated with prescription medication prior to the Screening visit and is non-responsive to corticosteroid treatment, as determined by the Investigator.
- Presence of any concurrent skin condition that could interfere with the evaluation of the study drug, as determined by the Investigator.
- History of adrenal disease
- Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
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 |
|---|---|---|
| IDP-118 Low StrengthAlso: IDP-1188 weeks | Drug | IDP-118 Low Strength |
| IDP-118 High StrengthAlso: IDP-1188 weeks | Drug | IDP-118 High Strength |
Primary outcome
The incidence of HPA axis suppression after treatment with investigational drug product and the comparators
Time frame: 8 weeks
To measure the incidence of HPA axis suppression after treatment with investigational drug product and the comparators
1 secondary outcome
To evaluate the safety and cutaneous tolerability of the two formulations and the comparators
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
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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.
Todd Plott, MD study director
Medical Monitor
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 IDP-118 Low Strength and IDP-118 High Strength in people with Plaque Psoriasis, run by Dow Pharmaceutical Sciences 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 6 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: status not confirmed, as of the sponsor's last update on 25 Apr 2013. 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. 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?
Results are not available in the source record.
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?
The incidence of HPA axis suppression after treatment with investigational drug product and the comparators (time frame: 8 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 25 Apr 2013.