Plaque PsoriasisPhase 2NCT02413229

A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study

A Phase 2 study testing DSXS1411 in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp 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?: DSXS1411
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 151 participants
Where: No sites listed yet
Study dates: Apr 2015to 29 Jan 2016
Phase: Phase 2
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 or non-pregnant, non-lactating females age 12 and older.
Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening.

Who cannot join

Under 12 years of age.
Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study.
Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.

About this study

Official title: A Randomized Double Blind Vehicle Controlled Dose Ranging Multiple Site Phase 2 Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Scalp Psoriasis

The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.

Read the detailed description

This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.

Conditions: Plaque Psoriasis
Being tested: DSXS1411, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DSXS1411Drug
Also called Active
DSXS (Taro Pharmaceuticals Inc.)
PlaceboDrug
Also called vehicle
Placebo (vehicle) (Taro Pharmaceuticals Inc.)

Study groups in NCT02413229
Study group	Role	What they receive
DSXS1411	Experimental	DSXS applied once a day for a total of 28 days. Receives: Drug: DSXS1411
Placebo	Placebo comparator	Placebo (vehicle) applied once a day for a total of 28 days. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Response of Success
The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.
Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201529 Jan 2016

First posted9 Apr 2015 (estimated)
Study startApr 2015
Primary completion14 Sep 2015
Study completion29 Jan 2016

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02413229
Sponsor's protocol ID: DSXS 1411
Status last verified: Nov 2018
First submitted: 6 Apr 2015
Last updated: 6 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 2
An Open-label Study of HS-20137 in Participants With Moderate-to-Severe Plaque Psoriasis
Moderate-to-severe Plaque Psoriasis
Not yet recruitingObservational study
A Real-world Study of Treatment Retention and Adherence to Secukinumab in Patients With Plaque Psoriasis (PsO) With or Without Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) Co-therapy
Plaque Psoriasis
Active, not recruitingPhase 3
A Phase 3 Clinical Study of QL2106 Injection
Plaque Psoriasis

All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double Blind Vehicle Controlled Dose Ranging Multiple Site Phase 2 Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Scalp Psoriasis
ClinicalTrials.gov ID: NCT02413229
Acronym / sponsor ID: DSXS 1411
Conditions: Plaque Psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2015 (actual)
Primary completion: 14 Sep 2015 (actual)
Study completion: 29 Jan 2016 (actual)
First posted: 9 Apr 2015 (estimated)
Results: Posted 6 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 objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DSXS1411	Experimental	Drug: DSXS1411DSXS applied once a day for a total of 28 days.
Placebo	Placebo comparator	Drug: PlaceboPlacebo (vehicle) applied once a day for a total of 28 days.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Male or non-pregnant, non-lactating females age 12 and older.
Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening.

Key exclusion criteria (3 listed)

Under 12 years of age.
Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study.
Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.

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
DSXS1411Also: ActiveDSXS (Taro Pharmaceuticals Inc.)	Drug	DSXS1411
PlaceboAlso: vehiclePlacebo (vehicle) (Taro Pharmaceuticals Inc.)	Drug	Placebo

Primary outcome

Clinical Response of Success
Time frame: 28 Days
The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.

Results and safety

Results posted to the registry on 6 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DSXS1411 5 Min	25	24
Placebo 5 Min	12	11
DSXS1411 10 Min	26	25
Placebo 10 Min	12	11
DSXS1411 15 Min	24	21
Placebo 15 Min	12	12
DSXS1411 30 Min	25	25
Placebo 30 Min	15	11

Primary outcome: Clinical Response of Success

Time frame: 28 Days. Count of participants. Unit: Participants

Measure	DSXS1411 5 Min n = 24	Placebo 5 Min n = 12	DSXS1411 10 Min n = 26	Placebo 10 Min n = 12	DSXS1411 15 Min n = 22	Placebo 15 Min n = 12	DSXS1411 30 Min n = 25	Placebo 30 Min n = 15
Value	6	4	6	1	6	1	11	1

DSXS1411 5 Min vs Placebo 5 Min: p = 0.3571, Cochran-Mantel-Haenszel
DSXS1411 10 Min vs Placebo 10 Min: p = 0.5224, Cochran-Mantel-Haenszel
DSXS1411 15 Min vs Placebo 15 Min: p = 0.3890, Cochran-Mantel-Haenszel

Adverse events

Time frame: 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DSXS1411 5 Min	0 of 24 (0%)	4 of 24 (16.7%)	0 of 24
Placebo 5 Min	0 of 12 (0%)	3 of 12 (25%)	0 of 12
DSXS1411 10 Min	0 of 26 (0%)	3 of 26 (11.5%)	0 of 26
Placebo 10 Min	0 of 12 (0%)	3 of 12 (25%)	0 of 12
DSXS1411 15 Min	0 of 22 (0%)	4 of 22 (18.2%)	0 of 22
Placebo 15 Min	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
DSXS1411 30 Min	0 of 25 (0%)	7 of 25 (28%)	0 of 25
Placebo 30 Min	0 of 15 (0%)	5 of 15 (33.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Plaque Psoriasis

RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 2
An Open-label Study of HS-20137 in Participants With Moderate-to-Severe Plaque Psoriasis
Moderate-to-severe Plaque Psoriasis
Not yet recruitingObservational study
A Real-world Study of Treatment Retention and Adherence to Secukinumab in Patients With Plaque Psoriasis (PsO) With or Without Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) Co-therapy
Plaque Psoriasis
Active, not recruitingPhase 3
A Phase 3 Clinical Study of QL2106 Injection
Plaque Psoriasis

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DSXS1411 in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries, Inc..

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 2 inclusion and 3 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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 6 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?

Clinical Response of Success (time frame: 28 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02413229.

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 Dec 2018; AzTrials last refreshed its copy on 27 Oct 2026.