PsoriasisPhase 3NCT01139580

The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis

A Phase 3 study testing Calcipotriene Foam in people with Psoriasis, run by Stiefel, a GSK Company at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Psoriasis
What is being tested?: Calcipotriene Foam
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 363 participants
Where: 26 sitesUnited States
Study dates: May 2010to Dec 2010
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
Male or female subjects at least 12 years old and in good general health.
Able to complete the study and to comply with study instructions.
Moderate plaque-type psoriasis on the body (excluding the scalp and face) defined as:
Plaque-type psoriasis involving 3% to 10% of total body surface area (BSA).
An Investigator's Static Global Assessment (ISGA) score of 3 at Baseline.

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Identification of a target lesion (>2 cm²) on the trunk or extremities with a score of 2 or 3 (0-5 scale) for erythema, scaling and plaque thickness. Lesions on the palms/soles, knees, elbow, and intertriginous areas should not be used as the target lesion site.
Involvement of at least 10% of the total scalp surface area with clinical signs (erythema, thickness, and scaliness) rated as moderate (3) based on the ISGA.
Negative urine pregnancy test for females of childbearing potential. • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are fewer than 2 years from their last menses.

Who cannot join

Any subject who has participated in any previous calcipotriene foam clinical.
Female who is pregnant, trying to become pregnant, or breastfeeding.
Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations.
History of hypercalcemia or of vitamin D toxicity.
Other serious skin disorder or any chronic medical condition that is not well-controlled.
Use of nonbiologic systemic anti-psoriatic therapy (eg, corticosteroids, psoralen combined with exposure to ultraviolet light A [PUVA], ultraviolet light B [UVB], retinoids, methotrexate, cyclosporine, other immunosuppressive agents) within 4 weeks prior to enrollment.

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Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (whichever is longer) for experimental products prior to randomization.
Use of topical therapies that have a known beneficial effect on psoriasis, including but not limited to corticosteroids, retinoids, Vitamin D derivatives, coal tar, or anthralin, within 2 weeks prior to enrollment.
Systemic medications for other medical conditions that are known to affect psoriasis (eg, lithium, beta adrenergic blockers) within 4 weeks prior to enrollment.
Use of any investigational product within 4 weeks prior to enrollment, currently participating in another clinical trial, or plans to receive an investigational product during the study.
Current drug or alcohol abuse (drug screening not required).
Has a history of any immuno-compromizing disease.
Any other condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
Employees of the investigator; study center; or Stiefel, a GSK company involved in the study; or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

DermReserach, Inc.
Austin, Texas, 78759
Group Health Associates
Cincinnatti, Ohio, 45220
Cherry Creek Research, Inc.
Denver, Colorado, 80209
Henry Ford Medical Center
Detroit, Michigan, 48202
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dermatology Consulting Services
High Point, North Carolina, 27262
Suzanne Bruce and Associates, PA
Houston, Texas, 77056
The Skin Wellness Center, PC
Knoxville, Tennessee, 37922
Dermatology Specialists
Louisville, Kentucky, 40202
DermResearch, PLLC
Louisville, Kentucky, 40217
Education and Research Foundation
Lynchburg, Virginia, 24501
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Tennessee Clinical Research
Nashville, Tennessee, 37215
Mt. Sinai School of Medicine Div. Dermatologic & Cosmetic Surgery
New York, New York, 10029
MedaPhase, Inc.
Newnan, Georgia, 30263
Miami Dermatology Research Institute LLC
North Miami Beach, Florida, 33169
Oregon Medical
Portland, Oregon, 97223
Dermatology Associates of Rochester, PC
Rochester, New York, 14623
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Therapeutics Clinical Research Center, Inc.
San Diego, California, 92123
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078
Central Dermatology PC
St Louis, Missouri, 63117
Genova Clinical Research
Tucson, Arizona, 85791
Grekin Skin Institute
Warren, Michigan, 48088
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind Study of the Safety and Efficacy of Calcipotriene Foam, 0.005%, Versus Vehicle Foam In The Treatment Of Moderate Plaque-Type Scalp And Body Psoriasis

The purpose of this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body.

Read the detailed description

The study subjects must have moderate psoriasis of the body and scalp with an ISGA of 3 at baseline. In addition, the subjects must have an evaluable target lesion of at least 2 cm² on the body with a score of 2 or 3 for erythema, scaling and plaque. All subjects will apply Calcipotriene Foam, 0.005% or vehicle foam topically twice a day (am and pm) to all psoriatic lesions on the body and scalp. Study visits will occur at baseline (day 1) and at weeks 1, 2, 4, and 8.

Conditions: Psoriasis
Being tested: Calcipotriene Foam, Vehicle Foam
Keywords: Plaque Psoriasis, Psoriasis
Medical subject headings: Psoriasis

What participants receive

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

Calcipotriene FoamDrug
Calcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
Vehicle FoamDrug
Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group

Study groups in NCT01139580
Study group	Role	What they receive
Calcipotriene Foam	Experimental	Calcipotriene Foam 0.005%, Receives: Drug: Calcipotriene Foam
Vehicle Foam	Placebo comparator	Vehicle Foam Receives: Drug: Vehicle Foam

What is being measured

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

Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method
The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.
Measured: Week 8
Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)
The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.
Measured: Week 8

Secondary outcomes (4)

Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8
Erythema is redness of the skin, caused by increased blood flow in the capillaries in the lower layers of the skin. The investigator assessed participants with erythema at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of erythema, hyperpigmentation may be present; 1, faint erythema; 2, light-red coloration; 3, moderate red coloration; 4, bright-red coloration; 5, dusky to deep red coloration.
Measured: Baseline and Week 8
Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8
Scaling of the skin is the loss of the outer layer of the epidermis in scale-like flakes. The investigator assessed participants with scaling at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of scaling; 1, minimal, occasional fine scale over less than 5% of the lesion; 2, mild, fine scales predominate; 3, moderate, coarse scales predominate; 4 marked, thick non-tenacious scale predominates; 5 severe, very thick tenacious scale predominates.
Measured: Baseline and Week 8
Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8
Psoriasis is a noncontagious skin disorder, most often appearing as inflamed, thickened skin covered with silvery white scales on the scalp, trunk, and limbs. The investigator assessed participants with plaque thickness at target lesions using the PGSTL scores: 0, no elevation over normal skin; 1, possible but difficult to ascertain whether there is a slight elevation above normal skin; 2, slight but definite elevation, edges are indistinct or sloped; 3, moderate elevation with rough or sloped edges; 4, marked elevation with hard or sharp edges; 5, very marked elevation with hard sharp edges.
Measured: Baseline and Week 8
Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8
The investigator assessed participants with psoriasis with body involvement using the ISGA, scored as: 0, clear, minor residual discoloration, no erythema, scaling, or plaque thickness; 1, almost clear, occasional fine scale, faint erythema, and barely perceptible plaque thickness; 2, mild, fine scales predominate with light-red coloration and mild plaque thickness; 3, moderate, coarse scales predominate with moderate red coloration and plaque thickness; 4 severe, thick tenacious scale predominates with deep red coloration and severe plaque thickness. Scores are a visual average of lesions.
Measured: Week 8

Timeline

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

May 2010Dec 2010

First posted8 Jun 2010 (estimated)
Study startMay 2010
Primary completionDec 2010
Study completionDec 2010

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.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 363 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01139580
Sponsor's protocol ID: 114743
Other IDs: U0267-303
Status last verified: Nov 2016
First submitted: 6 Jun 2010
Last updated: 18 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind Study of the Safety and Efficacy of Calcipotriene Foam, 0.005%, Versus Vehicle Foam In The Treatment Of Moderate Plaque-Type Scalp And Body Psoriasis
ClinicalTrials.gov ID: NCT01139580
Acronym / sponsor ID: 114743
Conditions: Psoriasis
Keywords: Plaque Psoriasis, Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 363 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: May 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 8 Jun 2010 (estimated)
Results: Posted 23 Sep 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 this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body.

Detailed description

Study design

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

Arm	Type	Receives
Calcipotriene Foam	Experimental	Drug: Calcipotriene FoamCalcipotriene Foam 0.005%,
Vehicle Foam	Placebo comparator	Drug: Vehicle FoamVehicle Foam

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
Male or female subjects at least 12 years old and in good general health.
Able to complete the study and to comply with study instructions.
Moderate plaque-type psoriasis on the body (excluding the scalp and face) defined as:
Involvement of at least 10% of the total scalp surface area with clinical signs (erythema, thickness, and scaliness) rated as moderate (3) based on the ISGA.

Key exclusion criteria (14 listed)

Any subject who has participated in any previous calcipotriene foam clinical.
Female who is pregnant, trying to become pregnant, or breastfeeding.
Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations.
History of hypercalcemia or of vitamin D toxicity.
Other serious skin disorder or any chronic medical condition that is not well-controlled.

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
Calcipotriene FoamCalcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group	Drug	Calcipotriene Foam
Vehicle FoamVehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group	Drug	Vehicle Foam

Primary outcome

Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method
Time frame: Week 8
The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.
Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)
Time frame: Week 8
The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.

4 secondary outcomes

Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8
Time frame: Baseline and Week 8
Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8
Time frame: Baseline and Week 8
Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8
Time frame: Baseline and Week 8
Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8
Time frame: Week 8

Results and safety

Results posted to the registry on 23 Sep 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
Calcipotriene Foam	181	158
Vehicle Foam	182	164

Primary outcome: Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method

Time frame: Week 8. Number. Unit: participants

Measure	Calcipotriene Foam n = 181	Vehicle Foam n = 182
Value	74	44

Calcipotriene Foam vs Vehicle Foam: p <0.001, Cochran-Mantel-Haenszel

Population analysed: Intent-to-Treat (ITT) Population: all participants who were randomized and dispensed study product. Missing values at Week 8 were considered to be failures. Failures were those participants who did not achieve a 2-grade improvement in IGSA score and a score of 0 or 1.

Primary outcome: Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)

Time frame: Week 8. Number. Unit: participants

Measure	Calcipotriene Foam n = 181	Vehicle Foam n = 182
Value	75	45

Calcipotriene Foam vs Vehicle Foam: p = 0.001, Cochran-Mantel-Haenszel

Population analysed: ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant will be used to estimate subsequent missing data points).

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Calcipotriene Foam	1 of 181 (0.6%)	25 of 181 (13.8%)	Not reported
Vehicle Foam	3 of 182 (1.6%)	17 of 182 (9.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Psoriasis

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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

26 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 Calcipotriene Foam in people with Psoriasis, run by Stiefel, a GSK Company at 26 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 9 inclusion and 14 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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. 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 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 23 Sep 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?

Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method (time frame: Week 8). 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?

On the ClinicalTrials.gov record for NCT01139580.

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 18 Jan 2017.