PsoriasisPhase 3NCT00658788

Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

A Phase 3 study testing clobetasol propionate spray 0.05% and calcitriol ointment in people with Psoriasis, run by Galderma R&D at 12 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 primary objectives of this study are to evaluate the safety \& efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Psoriasis
What is being tested?: clobetasol propionate spray 0.05% and calcitriol ointment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 305 participants
Where: 12 sitesUnited States
Study dates: Mar 2008to Jan 2009
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area
Overall Disease Severity of at least 3 (moderate)

Who cannot join

Surface area involvement too large (>20% BSA)
Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

J&J Studies, Inc
College Station, Texas, 77840
Hudson Dermatology
Evansville, Indiana, 47714
Suzanne Bruce and Associates, PA
Houston, Texas, 75390
Madison Skin and Research, Inc
Madison, Wisconsin, 53719
Mount Sinai Department of Dermatology
New York, New York, 10029
MedaPhase, Inc.
Newnan, Georgia, 30263
Virginia Clinical Research, Inc
Norfolk, Virginia, 23507
Central Sooner Research
Norman, Oklahoma, 73069
Therapeutics Clinical Research
San Diego, California, 92123
Dermatology Associates of Seattle, PLLC
Seattle, Washington, 98101
Gwinnett Clinical Research Center, Inc
Snellville, Georgia, 30078
Northeastern Ohio Universities College of Medicine
Warren, Ohio, 44483

Other trials in United States

About this study

Official title: A Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of a Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray, Followed by Calcitriol Ointment 3µg/g, in the Management of Moderate to Severe Plaque Psoriasis

The primary objectives of this study are to evaluate the safety \& efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Read the detailed description

Same as above.

Conditions: Psoriasis
Being tested: clobetasol propionate spray 0.05%, calcitriol ointment
Medical subject headings: Psoriasis

What participants receive

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

clobetasol propionate spray 0.05%Drug
Also called Clobex® Spray 0.05%
clobetasol propionate spray, 0.05%, applied topically twice daily
calcitriol ointmentDrug
calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Study groups in NCT00658788
Study group	Role	What they receive
Study Treatment	Active comparator	clobetasol propionate spray 0.05% Other Names: Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily calcitriol ointment Other Names: Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily Receives: Drug: clobetasol propionate spray 0.05%; Drug: calcitriol ointment

What is being measured

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

Overall Disease Severity Success (ODS)
Success was defined as a one-grade improvement in ODS from baseline.
Measured: 8 and 12 weeks

Secondary outcomes (11)

Global Improvement Score
Measured: 2, 4, 8 and 12 weeks
Signs of Psoriasis - Erythema
Measured: 2, 4, 8 and 12 weeks
Signs of Psoriasis - Scaling
Measured: 2, 4, 8 and 12 weeks
Signs of Psoriasis - Plaque Elevation
Measured: 2, 4, 8 and 12 weeks
Percent Change From Baseline in Body Surface Area (% BSA) Affected
Measured: 2, 4, 8 and 12 weeks
Overall Disease Severity
Measured: 2, 4, 8 and 12 weeks
Tolerability Assessment - Pruritus
Measured: Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Telangiectasias
Measured: Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Stinging/ Burning
Measured: Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Skin Atrophy
Measured: Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Folliculitis
Measured: Baseline, 2, 4, 8 and 12 weeks

Timeline

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

Mar 2008Jan 2009

First posted15 Apr 2008 (estimated)
Study startMar 2008
Primary completionJan 2009
Study completionJan 2009

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.
More trials run by Galderma R&DThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 305 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00658788
Sponsor's protocol ID: US10085
Status last verified: Sep 2012
First submitted: 4 Mar 2008
Last updated: 23 Aug 2022
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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Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of a Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray, Followed by Calcitriol Ointment 3µg/g, in the Management of Moderate to Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT00658788
Acronym / sponsor ID: US10085
Conditions: Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 305 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 15 Apr 2008 (estimated)
Results: Posted 27 Aug 2014

Clinical summary

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

The primary objectives of this study are to evaluate the safety \& efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Detailed description

Same as above.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study Treatment	Active comparator	Drug: clobetasol propionate spray 0.05%, Drug: calcitriol ointmentclobetasol propionate spray 0.05% Other Names: Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily calcitriol ointment Other Names: Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area
Overall Disease Severity of at least 3 (moderate)

Key exclusion criteria (2 listed)

Surface area involvement too large (>20% BSA)
Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas

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
clobetasol propionate spray 0.05%Also: Clobex® Spray 0.05%clobetasol propionate spray, 0.05%, applied topically twice daily	Drug	Study Treatment
calcitriol ointmentcalcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily	Drug	Study Treatment

Primary outcome

Overall Disease Severity Success (ODS)
Time frame: 8 and 12 weeks
Success was defined as a one-grade improvement in ODS from baseline.

11 secondary outcomes

Global Improvement Score
Time frame: 2, 4, 8 and 12 weeks
Signs of Psoriasis - Erythema
Time frame: 2, 4, 8 and 12 weeks
Signs of Psoriasis - Scaling
Time frame: 2, 4, 8 and 12 weeks
Signs of Psoriasis - Plaque Elevation
Time frame: 2, 4, 8 and 12 weeks
Percent Change From Baseline in Body Surface Area (% BSA) Affected
Time frame: 2, 4, 8 and 12 weeks
Overall Disease Severity
Time frame: 2, 4, 8 and 12 weeks
Tolerability Assessment - Pruritus
Time frame: Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Telangiectasias
Time frame: Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Stinging/ Burning
Time frame: Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Skin Atrophy
Time frame: Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Folliculitis
Time frame: Baseline, 2, 4, 8 and 12 weeks

Results and safety

Results posted to the registry on 27 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
Sequential Treatment Regimen	305	231

Primary outcome: Overall Disease Severity Success (ODS)

Time frame: 8 and 12 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Sequential Treatment Regimen n = 170
Week 8	100.0 (97.9 to 100.0)
Week 12	84.1 (77.7 to 89.3)

Population analysed: The per protocol population included 170 subjects who completed the 12 week regimen without any major protocol deviations.

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sequential Treatment Regimen	9 of 305 (3%)	0 of 305 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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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.

Ronald W Gottschalk, MD study director

Galderma R&D

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing clobetasol propionate spray 0.05% and calcitriol ointment in people with Psoriasis, run by Galderma R&D at 12 sites 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 2 inclusion and 2 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 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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. 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 27 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?

Overall Disease Severity Success (ODS) (time frame: 8 and 12 weeks). 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 NCT00658788.

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 23 Aug 2022.