Plaque PsoriasisPhase 3NCT02618759
Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis
A Phase 3 study testing DSXS in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- DSXS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2015to 25 Aug 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- male and non-pregnant females, 12 years of age or older, with a confirmed diagnosis of mild to moderate plaque psoriasis
Who cannot join
- patient is< 12 years old.
Trial locations and contacts
1 site in 1 country.
United States1 site
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, 10532
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis
The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.
Read the detailed description
To evaluate the therapeutic efficacy and safety of dsxs topical spray, 0.15% (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Placebo (vehicle) spray (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to moderate plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- DSXS, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSXSDrug
Also called Active
active treatment
PlaceboDrug
Also called vehicle
placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| DSXS1505 | Experimental | To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. Receives: Drug: DSXS; Drug: Placebo |
| Placebo | Placebo comparator | Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. Receives: Drug: DSXS; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2
The number of patients in each treatment group that have clinical success. Clinical Success is at least a 2-grade improvement from the baseline IGA score. The minimum IGA value is 0, and maximum value is 5. A higher number represents a more severe case of plaque psoriasis. Patients are required to have an IGA score of 2 or 3 at baseline, so all clinical success IGA scores will be either 0 or 1.
Measured: 28 Days
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2
The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2.
Measured: 28 Days
Secondary outcomes (4)
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)
The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 3, so any IGA score of 0 or 1 at Day 28 ± 2 would be a treatment success.
Measured: 28 Days
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)
The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 3.
Measured: 28 Days
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)
The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 2, so only an IGA score of 0 at Day 28 ± 2 would be a treatment success.
Measured: 28 Days
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)
The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 2.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start28 Aug 2015
- Primary completion16 Mar 2017
- Study completion25 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novum Pharmaceutical Research Services, Study chair, http://www.novumprs.com/contact
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618759
- Sponsor's protocol ID
- DSXS 1505
- Status last verified
- Dec 2018
- First submitted
- 1 Nov 2015
- Last updated
- 10 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02618759
- Acronym / sponsor ID
- DSXS 1505
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2015 (actual)
- Primary completion
- 16 Mar 2017 (actual)
- Study completion
- 25 Aug 2017 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Posted 10 Dec 2018
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 evaluate the therapeutic efficacy and safety of DSXS compared to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.
Detailed description
To evaluate the therapeutic efficacy and safety of dsxs topical spray, 0.15% (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Placebo (vehicle) spray (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to moderate plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSXS1505 | Experimental | Drug: DSXS, Drug: PlaceboTo evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. |
| Placebo | Placebo comparator | Drug: DSXS, Drug: PlaceboEligible patients will be randomized in a 1:1 ratio to Test or Placebo product. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- male and non-pregnant females, 12 years of age or older, with a confirmed diagnosis of mild to moderate plaque psoriasis
Key exclusion criteria (1 listed)
- patient is< 12 years old.
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 |
|---|---|---|
| DSXSAlso: Activeactive treatment | Drug | DSXS1505, Placebo |
| PlaceboAlso: vehicleplacebo treatment | Drug | DSXS1505, Placebo |
Primary outcome
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2
Time frame: 28 Days
The number of patients in each treatment group that have clinical success. Clinical Success is at least a 2-grade improvement from the baseline IGA score. The minimum IGA value is 0, and maximum value is 5. A higher number represents a more severe case of plaque psoriasis. Patients are required to have an IGA score of 2 or 3 at baseline, so all clinical success IGA scores will be either 0 or 1.
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2
Time frame: 28 Days
The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2.
4 secondary outcomes
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)
Time frame: 28 Days
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)
Time frame: 28 Days
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)
Time frame: 28 Days
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)
Time frame: 28 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Novum Pharmaceutical Research Services study chair
http://www.novumprs.com/contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DSXS in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 1 site 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 1 inclusion and 1 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 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (time frame: 28 Days). The study lists 2 primary outcomes in all. 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 10 Dec 2018.