PsoriasisNCT00437216
Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis
An observational study of Psoriasis, run by Galderma R&D at 1 site in United States.
Trial summary
Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents. 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, 0.05% and Clobetasol propionate, 0.05% Spray
- How many people
- 2,488 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jul 2006
- Phase
- Observational
- 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
Study population: Community Sample
Who may be able to join
- Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe
- At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter
- History of stable plaque psoriasis of greater than or equal to 3 months
Who cannot join
- Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis
- Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period
- Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits
Trial locations and contacts
1 site in 1 country.
United States1 site
DHC Dimensional HealthCare, Inc. (Clinical Research Organization)
Cedar Knolls, New Jersey, 76117
About this study
Official title: Phase 4 Open-Label Multicenter Community-based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX® Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis
Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents.
Read the detailed description
Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4.
- Conditions
- Psoriasis
- Being tested
- Clobetasol Propionate, 0.05%, Clobetasol propionate, 0.05% Spray
- 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, 0.05%Drug
Also called Clobex® Spray, 0.05%
Apply twice daily for 2 or 4 weeks as monotherapy
Clobetasol propionate, 0.05% SprayDrug
Also called Clobex® Spray, 0.05%
Apply twice daily for 2 or 4 weeks as add-on therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex® Receives: Drug: Clobetasol Propionate, 0.05% | |
| 2 | Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment Receives: Drug: Clobetasol propionate, 0.05% Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Change in Target Plaque Severity rating
Measured: 4 weeks
Secondary outcomes (2)
Efficacy - Self-Assessment of Quality of Life, Subject satisfaction
Measured: 4 weeks
Safety - Evaluation of adverse events and tolerability
Measured: 4 weeks
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 startFeb 2006
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 2,488 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
- NCT00437216
- Sponsor's protocol ID
- US10029
- Status last verified
- Mar 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
- Phase 4 Open-Label Multicenter Community-based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX® Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00437216
- Acronym / sponsor ID
- US10029
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,488 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (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.
Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents.
Detailed description
Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Clobetasol Propionate, 0.05%Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex® |
| 2 | – | Drug: Clobetasol propionate, 0.05% SprayAdd-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (3 listed)
- Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe
- At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter
- History of stable plaque psoriasis of greater than or equal to 3 months
Key exclusion criteria (3 listed)
- Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis
- Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period
- Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits
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® Spray, 0.05%Apply twice daily for 2 or 4 weeks as monotherapy | Drug | 1 |
| Clobetasol propionate, 0.05% SprayAlso: Clobex® Spray, 0.05%Apply twice daily for 2 or 4 weeks as add-on therapy | Drug | 2 |
Primary outcome
Efficacy - Change in Target Plaque Severity rating
Time frame: 4 weeks
2 secondary outcomes
Efficacy - Self-Assessment of Quality of Life, Subject satisfaction
Time frame: 4 weeks
Safety - Evaluation of adverse events and tolerability
Time frame: 4 weeks
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Galderma R&D 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 3 inclusion and 3 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 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.
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?
Efficacy - Change in Target Plaque Severity rating (time frame: 4 weeks). 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.