Scalp PsoriasisPhase 2NCT02933502
Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product
A Phase 2 study testing DSXS topical product in people with Scalp Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to SevereScalp Psoriasis Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- DSXS topical product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2016to 2 Jan 2018
- 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 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or non-pregnant, non-lactating females 12-17 years of age.
Who cannot join
- Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
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: An Open-label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS 1538b Topical Product Applied Once-daily in Patients With Moderate to Severe Scalp Psoriasis
An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to SevereScalp Psoriasis
Read the detailed description
- Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis.
- Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.
- Conditions
- Scalp Psoriasis
- Being tested
- DSXS topical product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSXS topical productDrug
Also called Active
treatment daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| DSXS topical product | Experimental | treatment with DSXS once daily for 28 days Receives: Drug: DSXS topical product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With HPA Axis Suppression
Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start11 Jul 2016
- Primary completion20 Sep 2017
- Study completion2 Jan 2018
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 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
- NCT02933502
- Sponsor's protocol ID
- DSXS 1538b
- Status last verified
- Dec 2018
- First submitted
- 11 Oct 2016
- 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
- An Open-label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS 1538b Topical Product Applied Once-daily in Patients With Moderate to Severe Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT02933502
- Acronym / sponsor ID
- DSXS 1538b
- Conditions
- Scalp Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2016 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 14 Oct 2016 (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.
An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to SevereScalp Psoriasis
Detailed description
- Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis.
- Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSXS topical product | Experimental | Drug: DSXS topical producttreatment with DSXS once daily for 28 days |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Male or non-pregnant, non-lactating females 12-17 years of age.
Key exclusion criteria (1 listed)
- Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
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 |
|---|---|---|
| DSXS topical productAlso: Activetreatment daily for 28 days | Drug | DSXS topical product |
Primary outcome
Number of Participants With HPA Axis Suppression
Time frame: day 28
Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation
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
Related trials for Scalp Psoriasis
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)
Plaque Psoriasis
RecruitingPhase 4
Immune Spatial Features of Guselkumab Cutaneous Response
Psoriasis of Scalp
Not yet recruitingObservational study
Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real)
Plaque Psoriasis, Psoriatic Arthritis
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 2 study testing DSXS topical product in people with Scalp 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. 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 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 Participants With HPA Axis Suppression (time frame: day 28). 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.