PsoriasisPhase 1NCT03058744
Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 1 study testing IDP-118 Lotion, HP Monad Lotion and Ultravate Cream in people with Psoriasis, run by Bausch Health Americas, Inc. at 12 sites in United States.
Trial summary
Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- IDP-118 Lotion, HP Monad Lotion and Ultravate Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 12 sitesUnited States
- Study dates
- Apr 2015to Jan 2017
- Phase
- Phase 1
- 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
- Male or Female of any race, at least 18 years old of age (inclusive)
- Freely provides both written and oral informed consent.
- Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation.
- Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%.
- The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Who cannot join
- Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator.
- Presents with psoriasis that was treated with prescription medication and failed to respond to presents).
- Has a history of adrenal disease.
- Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator.
- Is pregnant, nursing, or planning pregnancy during the study period.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Valeant Site 12
Anaheim, California, 92801
Valeant Site 08
Atlanta, Georgia, 30301
Valeant Site 03
Austin, Texas, 73301
Valeant Site 05
Encino, California, 91436
Valeant Site 02
Katy, Texas, 77449
Valeant Site 06
New York, New York, 10001
Valeant Site 10
Orange Park, Florida, 32065
Valeant Site 11
Philadelphia, Pennsylvania, 19019
Valeant Site 04
Plainfield, Indiana, 46168
Valeant Site 01
San Diego, California, 92093
Valeant Site 09
Sanford, Florida, 32771
Valeant Site 07
Santa Rosa, California, 95401
About this study
Official title: A Phase 1b Open Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.
Read the detailed description
A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.
- Conditions
- Psoriasis
- Being tested
- IDP-118 Lotion, HP Monad Lotion, Ultravate Cream, Tazorac Cream
- 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 LotionDrug
Also called Lotion
Lotion
HP Monad LotionDrug
Also called Lotion
Lotion
Ultravate CreamDrug
Also called Ultravate
Cream
Tazorac CreamDrug
Also called Taz
Cream
| Study group | Role | What they receive |
|---|---|---|
| IDP-118 Lotion | Experimental | 8 Weeks Receives: Drug: IDP-118 Lotion |
| HP Monad Lotion | Experimental | 8 Weeks Receives: Drug: HP Monad Lotion |
| Ultravate Cream | Active comparator | 2 Weeks Receives: Drug: Ultravate Cream |
| Tazorac Cream | Active comparator | 4 Weeks Receives: Drug: Tazorac Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Skin Reactions (LSRs)
Tolerability will be evaluated through assessment of local signs and symptoms (itching, dryness, burning/stinging) on a scale of non, mild, moderate, and severe.
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 posted23 Feb 2017
- Study startApr 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lindsey Mathew, Study director, Valeant Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058744
- Sponsor's protocol ID
- V01-118A-501
- Status last verified
- Jun 2017
- First submitted
- 21 Dec 2016
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Open Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03058744
- Acronym / sponsor ID
- V01-118A-501
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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.
Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.
Detailed description
A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IDP-118 Lotion | Experimental | Drug: IDP-118 Lotion8 Weeks |
| HP Monad Lotion | Experimental | Drug: HP Monad Lotion8 Weeks |
| Ultravate Cream | Active comparator | Drug: Ultravate Cream2 Weeks |
| Tazorac Cream | Active comparator | Drug: Tazorac Cream4 Weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female of any race, at least 18 years old of age (inclusive)
- Freely provides both written and oral informed consent.
- Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation.
- Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%.
- The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Key exclusion criteria (5 listed)
- Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator.
- Presents with psoriasis that was treated with prescription medication and failed to respond to presents).
- Has a history of adrenal disease.
- Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator.
- Is pregnant, nursing, or planning 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 LotionAlso: LotionLotion | Drug | IDP-118 Lotion |
| HP Monad LotionAlso: LotionLotion | Drug | HP Monad Lotion |
| Ultravate CreamAlso: UltravateCream | Drug | Ultravate Cream |
| Tazorac CreamAlso: TazCream | Drug | Tazorac Cream |
Primary outcome
Local Skin Reactions (LSRs)
Time frame: 8 Weeks
Tolerability will be evaluated through assessment of local signs and symptoms (itching, dryness, burning/stinging) on a scale of non, mild, moderate, and severe.
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 9 Jun 2017.
- Individual participant dataSharing planned: Yes
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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.
Lindsey Mathew study director
Valeant Pharmaceuticals
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IDP-118 Lotion, HP Monad Lotion and Ultravate Cream in people with Psoriasis, run by Bausch Health Americas, Inc. at 12 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 5 inclusion and 5 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 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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.
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?
Local Skin Reactions (LSRs) (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 9 Jun 2017.