Plaque-Type PsoriasisPhase 4NCT00852761
A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis
A Phase 4 study testing Olux-E Foam and Clobex lotion in people with Plaque-Type Psoriasis, run by Stiefel, a GSK Company at 1 site in United States.
Trial summary
The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque-Type Psoriasis
- What is being tested?
- Olux-E Foam and Clobex lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2009
- Phase
- Phase 4
- 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
- Body surface area (BSA) affected with psoriasis between 4% and 20% .
- Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.
- Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3).
- Definitive diagnosis of elbow and/or knee plaque-type psoriasis.
- Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
- Male or female, 18 years of age or older at the time that the consent form was signed.
- Able to complete the study and comply with study instructions.
- Female subjects of childbearing potential must have had a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception.
Who cannot join
- Use of any emollient applied to psoriasis plaques treated with the study medication during the study.
- Other serious skin disorder or any chronic medical condition that is not well controlled.
- Female subjects who are pregnant, trying to become pregnant or lactating.
- Any major illness within 30 days prior to the baseline visit.
- Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, 27157
About this study
Official title: A Study to Evaluate Safety and Efficacy of Clobetasol Propionate for Treatment of Plaque-Type Psoriasis in Adult Subjects.
The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.
Read the detailed description
This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.
- Conditions
- Plaque-Type Psoriasis
- Being tested
- Olux-E Foam, Clobex lotion
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olux-E FoamDrug
Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15.
Clobex lotionDrug
Also called clobetasol lotion, Clobex
Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15
| Study group | Role | What they receive |
|---|---|---|
| Olux-E Foam | Experimental | Olux-E (clobetasol propionate 0.05%) foam Receives: Drug: Olux-E Foam |
| Clobex lotion | Active comparator | Clobex (clobetasol propionate 0.05%) lotion. Receives: Drug: Clobex lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)
Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.
Measured: Baseline to day 15
Secondary outcomes (18)
At Least 1 Grade Improvement Psoriasis Grading Scale
Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.
The scale is the same as used for the primary outcome (0 through 5).
Measured: Baseline, days 3 and 8
At Least a 2 Grade Improvement Psoriasis Grading Scale
Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.
The scale is the same as used for the primary outcome (0 through 5).
Measured: Baseline, days 3, 8, 15
At Least a 3 Grade Improvement Psoriasis Grading Scale
Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.
The scale is the same as used for the primary outcome (0 through 5).
Measured: Baseline, days 3, 8, 15
At Least 1 Grade Improvement in the Psoriasis Global Assessment
Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
Measured: Baseline, days 3, 8, 15
At Least a 2 Grade Improvement in the Psoriasis Global Assessment
Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
Measured: Baseline, days 3, 8, 15
At Least a 3 Grade Improvement in the Psoriasis Global Assessment
Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
Measured: Baseline, days 3, 8, 15
At Least 1 Grade Improvement in Subject's Global Assessment
Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
Measured: Baseline, days 3, 8, 15
At Least a 2 Grade Improvement in Subject's Global Assessment
Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
Measured: Baseline, days 3, 8, 15
At Least a 3 Grade Improvement in Subject's Global Assessment
Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
Measured: Baseline, days 3, 8, 15
Median Change in Psoriasis Grading Scale
Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.
Measured: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Symptoms and Feelings
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Measured: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Daily Activities
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Measured: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Leisure
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Measured: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Work and School
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life
Measured: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Personal Relationships
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Measured: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Treatment
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life
Measured: Baseline, Days 3, 8, 15
Total Dermatology Life Quality Index (DLQI) Score
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.
Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life
Measured: Baseline, Days 3, 8, 15
Dermatology Life Quality Index (DLQI) Categories
Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life.
Measured: Days 3, 8, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionAug 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 Plaque-Type 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852761
- Sponsor's protocol ID
- 114569
- Other IDs
- U0280-402
- Status last verified
- Apr 2012
- First submitted
- 25 Feb 2009
- Last updated
- 23 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Safety and Efficacy of Clobetasol Propionate for Treatment of Plaque-Type Psoriasis in Adult Subjects.
- ClinicalTrials.gov ID
- NCT00852761
- Acronym / sponsor ID
- 114569
- Conditions
- Plaque-Type Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Posted 4 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.
Detailed description
This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olux-E Foam | Experimental | Drug: Olux-E FoamOlux-E (clobetasol propionate 0.05%) foam |
| Clobex lotion | Active comparator | Drug: Clobex lotionClobex (clobetasol propionate 0.05%) lotion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Body surface area (BSA) affected with psoriasis between 4% and 20% .
- Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.
- Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3).
- Definitive diagnosis of elbow and/or knee plaque-type psoriasis.
- Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
Key exclusion criteria (5 listed)
- Use of any emollient applied to psoriasis plaques treated with the study medication during the study.
- Other serious skin disorder or any chronic medical condition that is not well controlled.
- Female subjects who are pregnant, trying to become pregnant or lactating.
- Any major illness within 30 days prior to the baseline visit.
- Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during 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 |
|---|---|---|
| Olux-E FoamOlux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15. | Drug | Olux-E Foam |
| Clobex lotionAlso: clobetasol lotion, ClobexClobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15 | Drug | Clobex lotion |
Primary outcome
At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)
Time frame: Baseline to day 15
Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.
18 secondary outcomes
At Least 1 Grade Improvement Psoriasis Grading Scale
Time frame: Baseline, days 3 and 8
At Least a 2 Grade Improvement Psoriasis Grading Scale
Time frame: Baseline, days 3, 8, 15
At Least a 3 Grade Improvement Psoriasis Grading Scale
Time frame: Baseline, days 3, 8, 15
At Least 1 Grade Improvement in the Psoriasis Global Assessment
Time frame: Baseline, days 3, 8, 15
At Least a 2 Grade Improvement in the Psoriasis Global Assessment
Time frame: Baseline, days 3, 8, 15
At Least a 3 Grade Improvement in the Psoriasis Global Assessment
Time frame: Baseline, days 3, 8, 15
At Least 1 Grade Improvement in Subject's Global Assessment
Time frame: Baseline, days 3, 8, 15
At Least a 2 Grade Improvement in Subject's Global Assessment
Time frame: Baseline, days 3, 8, 15
At Least a 3 Grade Improvement in Subject's Global Assessment
Time frame: Baseline, days 3, 8, 15
Median Change in Psoriasis Grading Scale
Time frame: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Symptoms and Feelings
Time frame: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Daily Activities
Time frame: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Leisure
Time frame: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Work and School
Time frame: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Personal Relationships
Time frame: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Treatment
Time frame: Baseline, Days 3, 8, 15
Total Dermatology Life Quality Index (DLQI) Score
Time frame: Baseline, Days 3, 8, 15
Dermatology Life Quality Index (DLQI) Categories
Time frame: Days 3, 8, 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
- 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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olux-E Foam and Clobex lotion in people with Plaque-Type Psoriasis, run by Stiefel, a GSK Company 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 8 inclusion and 5 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 Apr 2012. 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.
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?
Yes. Results are posted in the registry (first posted 4 Oct 2011). 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?
At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale) (time frame: Baseline to day 15). 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 23 Apr 2012.