Atopic DermatitisPhase 3NCT02595073
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis
A Phase 3 study testing DSXS in people with Atopic Dermatitis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- DSXS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2015to 29 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (AD)
Who cannot join
- Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.
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 Moderate to Severe Atopic Dermatitis.
Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
Read the detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Being tested
- DSXS, Placebo
- Medical subject headings
- Dermatitis, Atopic
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 |
|---|---|---|
| DSXS topical product | Experimental | DSXS Active treatment Receives: Drug: DSXS |
| Placebo topical product | Placebo comparator | Placebo treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patients in Each Treatment Group That Have Clinical Success
Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear [0] or almost clear [1]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema
Measured: 28 days
Secondary outcomes (1)
Change From Baseline in %BSA Affected at Day 28 ± 2
The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 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 posted3 Nov 2015 (estimated)
- Study start4 Sep 2015
- Primary completion17 Jan 2017
- Study completion29 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 Atopic DermatitisStudies 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
- 124 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
- NCT02595073
- Sponsor's protocol ID
- DSXS 1504
- Status last verified
- Dec 2018
- First submitted
- 1 Nov 2015
- Last updated
- 7 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 7 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 Moderate to Severe Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT02595073
- Acronym / sponsor ID
- DSXS 1504
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2015 (actual)
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 29 Aug 2017 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Posted 7 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
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 topical product | Experimental | Drug: DSXSDSXS Active treatment |
| Placebo topical product | Placebo comparator | Drug: PlaceboPlacebo treatment |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (AD)
Key exclusion criteria (1 listed)
- Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.
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 | DSXS topical product |
| PlaceboAlso: vehiclePlacebo treatment | Drug | Placebo topical product |
Primary outcome
The Number of Patients in Each Treatment Group That Have Clinical Success
Time frame: 28 days
Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear [0] or almost clear [1]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema
1 secondary outcome
Change From Baseline in %BSA Affected at Day 28 ± 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 7 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 Atopic Dermatitis, 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 7 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 7 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?
The Number of Patients in Each Treatment Group That Have Clinical 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?
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 7 Dec 2018.