Scalp PsoriasisPhase 3NCT02932462
Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis
A Phase 3 study testing DSXS in people with Scalp Psoriasis, run by Sun Pharmaceutical Industries, Inc..
Trial summary
A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- DSXS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 373 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to 29 Sep 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
- Patients with a clinical diagnosis of mild to severe plaque psoriasis of the scalp, defined by an Investigator's Global Assessment (IGA) score of at least 2 at baseline/randomization
Who cannot join
- Patients whose scalp psoriasis necessitates systemic or other concomitant topical therapies during the study (concomitant treatment of body psoriasis with over the counter topical products including emollients, is allowed).
- Patient has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema, cutaneous T-cell lymphoma, or other forms of psoriasis including guttate, inverse, pustular or erythrodermic psoriasis)
- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters, including planned extensive exposure to sunlight during the study.
- History of psoriasis unresponsive to topical treatments.
- Current immunosuppression or history of organ transplant.
- Patients who have a history of or current diagnosis of glaucoma.
- Patients who have had surgery on the eyes or eyelids within 1 month before baseline or plan to have eye or eyelid surgery during the study.
- Patients with active infection (including but not limited to bacterial, fungal and viral infection) and/or open wounds on the entire head and neck area.
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS 1535 in Patients With Mild to Severe Scalp Psoriasis
A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study
Read the detailed description
This randomized, double-blind, vehicle-controlled, parallel-group multiple-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS 1535 product, for the treatment of mild to severe scalp psoriasis
- Conditions
- Scalp 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 DSXS 1535
topical product
PlaceboDrug
Also called vehicle
topical product
| Study group | Role | What they receive |
|---|---|---|
| DSXS 1535 | Experimental | DSXS 1535 topical product Receives: Drug: DSXS |
| Placebo | Placebo comparator | Vehicle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success in Patients With Moderate and Severe Scalp Psoriasis
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Measured: from baseline to study day 29
Clinical Success in Patients With Mild to Severe Scalp Psoriasis
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Measured: from baseline to study day 29
Secondary outcomes (1)
Clinical Success in Patients With Mild Scalp Psoriasis
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Measured: from baseline to study day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startMar 2016
- Primary completion1 Dec 2016
- Study completion29 Sep 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 Scalp 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
- 373 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/contactNatalie Yantovskiy, Study director, Taro Pharmaceuticals USA Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932462
- Sponsor's protocol ID
- DSXS 1535
- Status last verified
- Nov 2018
- First submitted
- 8 Oct 2016
- Last updated
- 6 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS 1535 in Patients With Mild to Severe Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT02932462
- Acronym / sponsor ID
- DSXS 1535
- Conditions
- Scalp Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 13 Oct 2016 (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.
A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study
Detailed description
This randomized, double-blind, vehicle-controlled, parallel-group multiple-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS 1535 product, for the treatment of mild to severe scalp 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 |
|---|---|---|
| DSXS 1535 | Experimental | Drug: DSXSDSXS 1535 topical product |
| Placebo | Placebo comparator | Drug: PlaceboVehicle |
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)
- Patients with a clinical diagnosis of mild to severe plaque psoriasis of the scalp, defined by an Investigator's Global Assessment (IGA) score of at least 2 at baseline/randomization
Key exclusion criteria (8 listed)
- Patients whose scalp psoriasis necessitates systemic or other concomitant topical therapies during the study (concomitant treatment of body psoriasis with over the counter topical products including emollients, is allowed).
- Patient has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema, cutaneous T-cell lymphoma, or other forms of psoriasis including guttate, inverse, pustular or erythrodermic psoriasis)
- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters, including planned extensive exposure to sunlight during the study.
- History of psoriasis unresponsive to topical treatments.
- Current immunosuppression or history of organ transplant.
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: DSXS 1535topical product | Drug | DSXS 1535 |
| PlaceboAlso: vehicletopical product | Drug | Placebo |
Primary outcome
Clinical Success in Patients With Moderate and Severe Scalp Psoriasis
Time frame: from baseline to study day 29
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Clinical Success in Patients With Mild to Severe Scalp Psoriasis
Time frame: from baseline to study day 29
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
1 secondary outcome
Clinical Success in Patients With Mild Scalp Psoriasis
Time frame: from baseline to study day 29
Results and safety
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 Scalp Psoriasis
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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
Natalie Yantovskiy study director
Taro Pharmaceuticals USA Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DSXS in people with Scalp 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 1 inclusion and 8 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 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 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 Success in Patients With Moderate and Severe Scalp Psoriasis (time frame: from baseline to study day 29). 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 6 Dec 2018; AzTrials last refreshed its copy on 7 Nov 2026.