PsoriasisPhase 4SCALPNCT00669214

A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp

A Phase 4 study testing efalizumab in people with Psoriasis, run by Genentech, Inc..

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: efalizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: No sites listed yet
Study dates: Feb 2008to Jan 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

Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents
Be aged 18 years or older
Have chronic (6 months or greater) moderate to severe plaque psoriasis with involvement of the scalp
Have a whole body Physician's Global Assessment (PGA) rating of moderate (3) or severe (4) for psoriasis
Have a scalp surface area affected by plaque psoriasis of 30% or more, assessed using Psoriasis Scalp Severity Index (PSSI)
Have at least one of three clinical signs involving the scalp (erythema, induration, and desquamation) be rated as at least moderate (2) with the other two rated as at least slight (1) using PSSI

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Be a candidate for systemic therapy in the opinion of the investigator
Be naive to efalizumab treatment
For women of childbearing potential, must be willing to use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab

Who cannot join

Have had previous exposure to efalizumab or a history of hypersensitivity to any of its components
Are using any excluded therapy
Have a history of drug or alcohol abuse in the past five years
Have a history in the past 5 years of a serious infection or currently have an ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
Have any history of opportunistic infections (e.g., systemic fungal infections, parasites)
Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)

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Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis, including latent tuberculosis with isoniazid
Have the presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
Are pregnant or breastfeeding
Have a diagnosis of hepatic cirrhosis, regardless of cause or severity
Have a history in the last 5 years of thrombocytopenia
Have a history in the last 5 years of hemolytic anemia or any other clinically significant anemia
Have been exposed to any experimental and/or unapproved drugs or treatments within 30 days or 5 half-lives, whichever is longer, before the screening visit
Have been vaccinated with a live virus or live bacteria within the 14 days before the first dose of efalizumab
Have any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug (efalizumab or placebo equivalent) or would significantly interfere with the patient's ability to comply with the provisions of this protocol

About this study

Official title: A Phase IV Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of 1.0 mg/kg Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp

This was a Phase IV randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of subcutaneous efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis with involvement of the scalp who had no previous exposure to efalizumab. The study consisted of a screening period, a double-blind treatment period, an open-label treatment period, and an observation/follow-up period. The study enrolled 100 patients. 11 patients were excluded from all analyses because of data issues.

Read the detailed description

Baselines for Raptiva group and placebo group at Day 84 are the same. The baseline is Day 0.
Baselines for Raptiva group and placebo group at Day 168 are different. The baseline for Raptiva group at Day 168 is Day 0, but the baseline for Placebo group at Day 168 is Day 84

Conditions: Psoriasis
Being tested: efalizumab, placebo
Keywords: Raptiva, Moderate plaque psoriasis, Severe plaque psoriasis, Scalp
Medical subject headings: Psoriasis

What participants receive

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

efalizumabDrug
Also called Raptiva
All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
placeboDrug
All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).

Study groups in NCT00669214
Study group	Role	What they receive
Efalizumab	Experimental	Not described Receives: Drug: efalizumab
Placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

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

Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks
Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
Measured: Week 12

Secondary outcomes (11)

Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks
Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
Measured: Week 24
Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks
Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
Measured: Week 12
Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks
Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
Measured: Week 24
Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks
Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 12 weeks (Day 84)
Physician's Global Assessment (PGA) scale:
0: Clear. No signs of plaque psoriasis.
1. Almost clear. Just perceptible erythema and just perceptible scaling.
2. Mild disease. Light pink erythema with minimal scaling.
3. Moderate disease. Dull red, clearly distinguishable erythema with diffuse scaling, some thickening.
4. Severe disease. Deep/dark red erythema with clearly obvious and diffuse scaling and thickening.
Measured: Week 12
Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks
Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 24 weeks (Day 168) For details on the PGA scale, refer to the Secondary Outcome Measure Description for 12 weeks.
Measured: Week 24
Mean Change in Scalpdex Score at 12 Weeks
Mean change in Scalpdex score at 12 weeks (Day 84) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.
Measured: The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84
Mean Change in Scalpdex Score at 24 Weeks
Mean change in Scalpdex score at 24 weeks (Day 168) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.
Measured: Week 24
Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks
Mean change in VAS of patient-reported scalp itch at 12 weeks (Day 84) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was "no itching," 5 was "moderate itching," and 10 was "severe itching."
Measured: Week 12
Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks
Mean change in VAS of patient-reported scalp itch at 24 weeks (Day 168) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was "no itching," 5 was "moderate itching," and 10 was "severe itching."
Measured: Week 24
Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks
Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 12 weeks (Day 84) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the "rule of palm" to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint).
Measured: Week 12
Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks
Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 24 weeks (Day 168) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the "rule of palm" to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint).
Measured: Week 24

Timeline

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

Feb 2008Jan 2009

First posted30 Apr 2008 (estimated)
Study startFeb 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 Genentech, Inc.The 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00669214
Sponsor's protocol ID: ACD4412n
Acronym: SCALP
Status last verified: May 2017
First submitted: 28 Apr 2008
Last updated: 6 Jun 2017
Results posted: Yes, on ClinicalTrials.gov

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?

Official record

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
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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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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of 1.0 mg/kg Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp
ClinicalTrials.gov ID: NCT00669214
Acronym / sponsor ID: SCALP / ACD4412n
Conditions: Psoriasis
Keywords: Raptiva, Moderate plaque psoriasis, Severe plaque psoriasis, Scalp
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2008 (actual)
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 30 Apr 2008 (estimated)
Results: Posted 14 Feb 2011

Clinical summary

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

Detailed description

Baselines for Raptiva group and placebo group at Day 84 are the same. The baseline is Day 0.
Baselines for Raptiva group and placebo group at Day 168 are different. The baseline for Raptiva group at Day 168 is Day 0, but the baseline for Placebo group at Day 168 is Day 84

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Efalizumab	Experimental	Drug: efalizumab
Placebo	Placebo comparator	Drug: placebo

Who may qualify

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

Key inclusion criteria (9 listed)

Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents
Be aged 18 years or older
Have chronic (6 months or greater) moderate to severe plaque psoriasis with involvement of the scalp
Have a whole body Physician's Global Assessment (PGA) rating of moderate (3) or severe (4) for psoriasis
Have a scalp surface area affected by plaque psoriasis of 30% or more, assessed using Psoriasis Scalp Severity Index (PSSI)

Key exclusion criteria (15 listed)

Have had previous exposure to efalizumab or a history of hypersensitivity to any of its components
Are using any excluded therapy
Have a history of drug or alcohol abuse in the past five years
Have a history in the past 5 years of a serious infection or currently have an ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
Have any history of opportunistic infections (e.g., systemic fungal infections, parasites)

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
efalizumabAlso: RaptivaAll patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).	Drug	Efalizumab
placeboAll patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).	Drug	Placebo

Primary outcome

Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks
Time frame: Week 12
Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.

11 secondary outcomes

Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks
Time frame: Week 24
Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks
Time frame: Week 12
Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks
Time frame: Week 24
Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks
Time frame: Week 12
Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks
Time frame: Week 24
Mean Change in Scalpdex Score at 12 Weeks
Time frame: The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84
Mean Change in Scalpdex Score at 24 Weeks
Time frame: Week 24
Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks
Time frame: Week 12
Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks
Time frame: Week 24
Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks
Time frame: Week 12
Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks
Time frame: Week 24

Results and safety

Results posted to the registry on 14 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	27	22
Efalizumab	62	55

Primary outcome: Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks

Time frame: Week 12. Number. Unit: Proportion of patients

Measure	Placebo n = 27	Efalizumab n = 62
Value	0.111	0.274

Placebo vs Efalizumab: Difference in proportion: 0.163 (95% CI -0.063 to 0.393), p = 0.1054, Fisher Exact

Population analysed: Intent-to-treat (ITT) population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Double-blind (12 weeks), open-label (24 weeks), and follow-up. Patients entered each period as follows: Double-blind: placebo n = 27; efalizumab n = 62 Open-label: placebo n = 22; efalizumab n = 55 Follow-up: placebo n = 18; efalizumab n = 48. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo: Double-Blind Period	1 of 27 (3.7%)	11 of 27 (40.7%)	Not reported
Efalizumab: Double-Blind Period	1 of 62 (1.6%)	32 of 55 (58.2%)	Not reported
Placebo: Open-Label Period	0 of 22 (0%)	11 of 22 (50%)	Not reported
Efalizumab: Open-Label Period	1 of 55 (1.8%)	22 of 55 (40%)	Not reported
Placebo: Follow-Up Period	0 of 18 (0%)	3 of 18 (16.7%)	Not reported
Efalizumab: Follow-Up Period	2 of 48 (4.2%)	15 of 48 (31.3%)	Not reported

Limitations and caveats (from the sponsor): Since the completion of this study, efalizumab has been voluntarily withdrawn from the U.S. market because of a safety issue.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
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
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RecruitingPhase 1
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RecruitingPhase 1
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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.

Ivor Caro, M.D. study director

Genentech, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing efalizumab in people with Psoriasis, run by Genentech, Inc..

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 9 inclusion and 15 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 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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 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 14 Feb 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?

Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks (time frame: Week 12). 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 NCT00669214.

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 6 Jun 2017.