Plaque PsoriasisPhase 4NCT00437255
Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis
A Phase 4 study testing Clobetasol Propionate, 0.05% and Calcipotriene and betamethasone dipropionate ointment in people with Plaque Psoriasis, run by Galderma R&D at 4 sites in United States.
Trial summary
Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Clobetasol Propionate, 0.05% and Calcipotriene and betamethasone dipropionate ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2006to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Moderate to severe psoriasis involving 3-20% of the body surface area
Who cannot join
- Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® Spray or more than 100 grams per week of Taclonex® Ointment
- Subjects having psoriasis that involves the scalp, face, or groin
Trial locations and contacts
4 sites in 1 country.
United States4 sites
DermResearch, Inc.
Austin, Texas, 78759
J & S Studies, Inc.
Bryan, Texas, 77802
Baylor Research Institute
Dallas, Texas, 75230
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
About this study
Official title: An Evaluation of the Efficacy, Safety, Preference and Duration of Response of Clobex® (Clobetasol Propionate) Spray and Taclonex® (Calcipotriene 0.05%/Betamethasone Dipropionate 0.064%) Ointment in Subjects With Stable Plaque Psoriasis
Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.
Read the detailed description
Same as above.
- Conditions
- Plaque Psoriasis
- Being tested
- Clobetasol Propionate, 0.05%, Calcipotriene and betamethasone dipropionate ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobetasol Propionate, 0.05%Drug
Also called Clobex® Spray
Topical, twice daily for 4 weeks
Calcipotriene and betamethasone dipropionate ointmentDrug
Also called Taclonex® Ointment
Topical, once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Clobex® Spray Receives: Drug: Clobetasol Propionate, 0.05% |
| 2 | Active comparator | Taclonex® Ointment Receives: Drug: Calcipotriene and betamethasone dipropionate ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Disease Severity
Measured: End of treatment (Week 4)
Tolerability assessments, incidence of adverse events
Measured: Baseline, Weeks 1, 2, 4 and 8
Secondary outcomes (2)
Overall Disease Severity
Measured: Weeks 1, 2 and 8
Investigator Global Assessment
Measured: End of treatment (week 4) and Weeks 1, 2 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startAug 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ronald W Gottschalk, MD, Study director, Galderma Laboratories, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437255
- Sponsor's protocol ID
- US10034
- Status last verified
- Apr 2008
- First submitted
- 16 Feb 2007
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Efficacy, Safety, Preference and Duration of Response of Clobex® (Clobetasol Propionate) Spray and Taclonex® (Calcipotriene 0.05%/Betamethasone Dipropionate 0.064%) Ointment in Subjects With Stable Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00437255
- Acronym / sponsor ID
- US10034
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.
Detailed description
Same as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Clobetasol Propionate, 0.05%Clobex® Spray |
| 2 | Active comparator | Drug: Calcipotriene and betamethasone dipropionate ointmentTaclonex® Ointment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe psoriasis involving 3-20% of the body surface area
Key exclusion criteria (2 listed)
- Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® Spray or more than 100 grams per week of Taclonex® Ointment
- Subjects having psoriasis that involves the scalp, face, or groin
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, 0.05%Also: Clobex® SprayTopical, twice daily for 4 weeks | Drug | 1 |
| Calcipotriene and betamethasone dipropionate ointmentAlso: Taclonex® OintmentTopical, once daily | Drug | 2 |
Primary outcome
Overall Disease Severity
Time frame: End of treatment (Week 4)
Tolerability assessments, incidence of adverse events
Time frame: Baseline, Weeks 1, 2, 4 and 8
2 secondary outcomes
Overall Disease Severity
Time frame: Weeks 1, 2 and 8
Investigator Global Assessment
Time frame: End of treatment (week 4) and Weeks 1, 2 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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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 Laboratories, LP
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clobetasol Propionate, 0.05% and Calcipotriene and betamethasone dipropionate ointment in people with Plaque Psoriasis, run by Galderma R&D at 4 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 1 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 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: End of treatment (Week 4)). 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 29 Jul 2022.