PsoriasisPhase 2NCT01018134

Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

A Phase 2 study testing Desoximetasone 0.05% once daily, Desoximetasone 0.05% twice daily and Desoximetasone 0.25% once daily in people with Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 7 sites in United States.

Completed

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

Official record

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Trial summary

The objectives of this study are to evaluate the efficacy and safety of two dosing regimens of desoximetasone 0.05% and 0.25% topical sprays as compared to a vehicle spray in patients with moderate to severe plaque psoriasis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: Desoximetasone 0.05% once daily, Desoximetasone 0.05% twice daily and Desoximetasone 0.25% once daily
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 151 participants
Where: 7 sitesUnited States
Study dates: Nov 2009to May 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA).
Have a combined total lesion severity score (TLSS) of ≥ 7 for the target lesion.
Have a plaque elevation score ≥ 3 of (moderate) for the target lesion.
The target lesion must have an area of at least 5 cm².
Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.

Who cannot join

Pregnancy
Current diagnosis of other types of psoriasis other than stable plaque psoriasis or has psoriasis of any kind of the face or scalp that will require active treatment during the study.
History of psoriasis that has been unresponsive to topical corticosteroid therapy.
Dermatological conditions that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
Allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which would compromise the safety of the patient or the results of the study.
Any condition that would place the study patient at undue risk by participation in the study.

Show all 13Show fewer

Radiation therapy, antineoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug.
Treatment with any systemic or photo antipsoriatic therapy, within 8 weeks of the first dose of study drug.
Treatment within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis.
Systemic steroids within 4 weeks of the first dose of the study drug. The use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study.
Hormonal contraceptives for less than one complete cycle prior to entering the study.
Topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study.
Receipt of any drug as part of a research study within 30 days prior to first dosing.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Investigator Site
Albuquerque, New Mexico
Investigator Site
Cincinnati, Ohio
Investigator Site
Martinez, Georgia
Investigator Site
Miami, Florida
Investigator Site
Olathe, Kansas
Investigator Site
Simpsonville, South Carolina
Investigator Site
Wichita, Kansas

Other trials in United States

About this study

Official title: A Double-Blind, Vehicle-Controlled, Randomized, Dose Ranging, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone Topical Sprays (0.05%, 0.25%) in Patients With Moderate to Severe Plaque Psoriasis

Conditions: Psoriasis
Being tested: Desoximetasone 0.05% once daily, Desoximetasone 0.05% twice daily, Desoximetasone 0.25% once daily, Vehicle once daily, Vehicle twice daily
Keywords: Psoriasis, Topical corticosteroids, Plaque psoriasis
Medical subject headings: Psoriasis

What participants receive

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

Desoximetasone 0.05% once dailyDrug
Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
Desoximetasone 0.05% twice dailyDrug
Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
Desoximetasone 0.25% once dailyDrug
Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days
Desoximetasone 0.25% once dailyDrug
Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days
Vehicle once dailyDrug
Vehicle topical spray administered to affected areas once daily for 28 days
Vehicle twice dailyDrug
Vehicle topical spray administered to affected areas twice daily for 28 days

Study groups in NCT01018134
Study group	Role	What they receive
Desoximetasone 0.05% once daily	Experimental	Desoximetasone topical spray 0.05% administered once daily to affected area Receives: Drug: Desoximetasone 0.05% once daily
Desoximetasone 0.05% twice daily	Experimental	Desoximetasone topical spray 0.05% administered twice daily to affected area Receives: Drug: Desoximetasone 0.05% twice daily
Desoximetasone 0.25% once daily	Experimental	Desoximetasone topical spray 0.25% administered once daily to affected area Receives: Drug: Desoximetasone 0.25% once daily
Desoximetasone 0.25% twice daily	Experimental	Desoximetasone topical spray 0.25% administered twice daily to affected area Receives: Drug: Desoximetasone 0.25% once daily
Vehicle once daily	Placebo comparator	Vehicle administered to affected areas once daily Receives: Drug: Vehicle once daily
Vehicle twice daily	Placebo comparator	Vehicle administered to affected areas twice daily Receives: Drug: Vehicle twice daily

What is being measured

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

Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28
The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)
The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population.
On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1.
A score of 0 = Clear or 1= Almost Clear was considered clinical success.
A patient will be considered a Clinical Failure if: the patient's PGA score is > 1, the patient was considered to have an insufficient therapeutic response
Measured: 28 days
Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).
The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28.
Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.
A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success.
Measured: Day 28

Secondary outcomes (3)

Mean Change From Baseline in PGA Score at Day 28 Using the ITT
Physician Global Assessment (PGA) of Psoriasis is scored based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease.
Measured: Day 28
Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28
Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.
Measured: Day 28
Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).
Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.
BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared
%Body Surface Area Affected the "Rule of Nine" was be used.
Measured: Day 28

Timeline

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

Nov 2009May 2010

First posted23 Nov 2009 (estimated)
Study startNov 2009
Primary completionMay 2010
Study completionMay 2010

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 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01018134
Sponsor's protocol ID: DSXS 0906.00
Other IDs: 70915004
Status last verified: Jul 2014
First submitted: 19 Nov 2009
Last updated: 5 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Vehicle-Controlled, Randomized, Dose Ranging, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone Topical Sprays (0.05%, 0.25%) in Patients With Moderate to Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT01018134
Acronym / sponsor ID: DSXS 0906.00
Conditions: Psoriasis
Keywords: Psoriasis, Topical corticosteroids, 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: Nov 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 23 Nov 2009 (estimated)
Results: Posted 5 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Desoximetasone 0.05% once daily	Experimental	Drug: Desoximetasone 0.05% once dailyDesoximetasone topical spray 0.05% administered once daily to affected area
Desoximetasone 0.05% twice daily	Experimental	Drug: Desoximetasone 0.05% twice dailyDesoximetasone topical spray 0.05% administered twice daily to affected area
Desoximetasone 0.25% once daily	Experimental	Drug: Desoximetasone 0.25% once dailyDesoximetasone topical spray 0.25% administered once daily to affected area
Desoximetasone 0.25% twice daily	Experimental	Drug: Desoximetasone 0.25% once dailyDesoximetasone topical spray 0.25% administered twice daily to affected area
Vehicle once daily	Placebo comparator	Drug: Vehicle once dailyVehicle administered to affected areas once daily
Vehicle twice daily	Placebo comparator	Drug: Vehicle twice dailyVehicle administered to affected areas twice daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA).
Have a combined total lesion severity score (TLSS) of ≥ 7 for the target lesion.
Have a plaque elevation score ≥ 3 of (moderate) for the target lesion.
The target lesion must have an area of at least 5 cm².
Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.

Key exclusion criteria (13 listed)

Pregnancy
Current diagnosis of other types of psoriasis other than stable plaque psoriasis or has psoriasis of any kind of the face or scalp that will require active treatment during the study.
History of psoriasis that has been unresponsive to topical corticosteroid therapy.
Dermatological conditions that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
Allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which would compromise the safety of the patient or the results of the study.

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
Desoximetasone 0.05% once dailyDesoximetasone topical spray 0.05% administered to affected area once daily for 28 days	Drug	Desoximetasone 0.05% once daily
Desoximetasone 0.05% twice dailyDesoximetasone topical spray 0.05% administered to affected area twice daily for 28 days	Drug	Desoximetasone 0.05% twice daily
Desoximetasone 0.25% once dailyDesoximetasone topical spray 0.25% administered to affected area once daily for 28 days	Drug	Desoximetasone 0.25% once daily
Desoximetasone 0.25% once dailyDesoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days	Drug	Desoximetasone 0.25% twice daily
Vehicle once dailyVehicle topical spray administered to affected areas once daily for 28 days	Drug	Vehicle once daily
Vehicle twice dailyVehicle topical spray administered to affected areas twice daily for 28 days	Drug	Vehicle twice daily

Primary outcome

Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28
Time frame: 28 days
The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation) The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population. On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1. A score of 0 = Clear or 1= Almost Clear was considered clinical success. A patient will be considered a Clinical Failure if: the patient's PGA score is > 1, the patient was considered to have an insufficient therapeutic response
Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).
Time frame: Day 28
The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components. A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success.

3 secondary outcomes

Mean Change From Baseline in PGA Score at Day 28 Using the ITT
Time frame: Day 28
Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28
Time frame: Day 28
Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).
Time frame: Day 28

Results and safety

Results posted to the registry on 5 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Desoximetasone 0.05% Once Daily	30	30
Desoximetasone 0.05% Twice Daily	31	30
Desoximetasone 0.25% Once Daily	30	29
Desoximetasone 0.25% Twice Daily	29	29
Vehicle Once Daily	15	15
Vehicle Twice Daily	15	15

Primary outcome: Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28

Time frame: 28 days. Number. Unit: percentage of participants

Measure	Desoximetasone 0.05% Once Daily n = 30	Desoximetasone 0.05% Twice Daily n = 30	Desoximetasone 0.25% Once Daily n = 29	Desoximetasone 0.25% Twice Daily n = 29	Vehicle Once Daily n = 15	Vehicle Twice Daily n = 15
Value	13.33	10.00	20.69	37.93	6.67	6.67

Desoximetasone 0.05% Once Daily vs Vehicle Once Daily: p = 0.4261, t-test, 1 sided
Desoximetasone 0.05% Twice Daily vs Vehicle Twice Daily: p = 0.4219, t-test, 1 sided
Desoximetasone 0.25% Once Daily vs Vehicle Once Daily: p = 0.1826, t-test, 1 sided

Population analysed: The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.

Primary outcome: Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).

Time frame: Day 28. Number. Unit: percentage of Participants

Measure	Desoximetasone 0.05% Once Daily n = 30	Desoximetasone 0.05% Twice Daily n = 30	Desoximetasone 0.25% Once Daily n = 29	Desoximetasone 0.25% Twice Daily n = 29	Vehicle Once Daily n = 15	Vehicle Twice Daily n = 15
Value	6.67	16.67	34.48	31.03	6.67	6.67

Desoximetasone 0.05% Once Daily vs Vehicle Once Daily: p = 0.2631, t-test, 1 sided
Desoximetasone 0.05% Twice Daily vs Vehicle Twice Daily: p = 0.2968, t-test, 1 sided
Desoximetasone 0.25% Once Daily vs Vehicle Once Daily: p = 0.0186, t-test, 1 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Desoximetasone 0.05% Once Daily	0 of 30 (0%)	6 of 30 (20%)	Not reported
Desoximetasone 0.05% Twice Daily	0 of 31 (0%)	2 of 31 (6.5%)	Not reported
Desoximetasone 0.25% Once Daily	0 of 30 (0%)	7 of 30 (23.3%)	Not reported
Desoximetasone 0.25% Twice Daily	0 of 29 (0%)	4 of 29 (13.8%)	Not reported
Vehicle Once Daily	0 of 15 (0%)	5 of 15 (33.3%)	Not reported
Vehicle Twice Daily	0 of 15 (0%)	6 of 15 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 13 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 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 5 Aug 2014). 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 in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28 (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?

On the ClinicalTrials.gov record for NCT01018134.

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 5 Aug 2014.