Psoriasis VulgarisPhase 4TRIANGLENCT02004574
Study for Treatment With Calcipotriol/Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris
A Phase 4 study testing Calcipotriol/betamethasone dipropionate gel in people with Psoriasis Vulgaris, run by Jooheung Lee at 1 site in South Korea.
Trial summary
The combination of calcipotriol and betamethasone dipropionate used in an ointment formulation (Daivobet® ointment) has shown to have an excellent efficacy and safety in the short-term and long-term management of psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Calcipotriol/betamethasone dipropionate gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Jun 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 19 years and above
- Clinical diagnosis of stable psoriasis vulgaris of at least 4 weeks duration involving the non-scalp regions of the body (trunk and/or limbs) amenable to treatment with a maximum of 100 g of topical medication per week at screening
- An investigator's global assessment of disease severity(IGA) of at least mild on the body (trunk and/or limbs) at Day 0 (Baseline)
- Signed written informed consent prior to performance of any study-specific procedures or assessments, and must be willing to comply with treatment and follow up
- Able to communicate with the investigator and understand and comply with the requirements of the study
- Women of childbearing potential must have a negative pregnancy test and must use adequate contraception during the treatment phase of the study and for at least 1 week after the last application of study medication
Who cannot join
- Body surface area (BSA) > 10 % or Psoriasis Area and Severity Index (PASI) > 10 at baseline
- The palm of one hand is approximately 1 percent of the body surface area
- Subjects with unstable forms of psoriasis including guttate, erythrodermic, exfoliative and pustular psoriasis, or psoriatic arthritis
- Subjects with known disorders of calcium metabolism/hypercalcemia
- Subjects with hypersensitivity to the active substances or to any of the excipients of the investigational products
- Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within the following time periods prior to baseline visit
Show all 28Show fewer
- etanercept - within 4 weeks prior to baseline
- adalimumab, alefacept, infliximab - within 2 months prior to baseline
- ustekinumab - within 4 months prior to baseline
- investigational product - within 4 weeks/5 half-lives (whichever is longer) prior to baseline
- Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, cyclosporine and other immunosuppressants) within 4 weeks prior to baseline visit
- Phototherapy within the following time periods prior to baseline visit
- PUVA or Grenz ray - within 4 weeks
- UV-B - within 2 weeks
- Any topical treatment of the trunk and/or limbs (except for emollients) within 2 weeks prior to baseline visit
- Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with class 1- 5 corticosteroids or vitamin D analogues within 2 weeks prior to baseline visit
- Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with class 1-5 corticosteroids, vitamin D analogues within 2 weeks prior to baseline visit
- Subjects with severe renal insufficiency
- Subjects with severe hepatic disorders
- Subjects with a confounding skin condition or disorders against psoriasis evaluation
- Subjects with viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections on the treatment area
- Subjects with skin manifestations in relation to tuberculosis or syphilis on the treatment area
- Subjects with perioral dermatitis, atrophic skin, striae atrophicae on the treatment area
- Subjects with fragility of skin veins, ichthyosis on the treatment area
- Subjects with acne vulgaris, rosacea, wounds, ulcers, perianal and genital pruritus on the treatment area
- Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, anti-malarials, lithium, ACE inhibitors) during the study
- Pregnant or lactating female subjects
- Subjects who are planning a pregnancy during the entire study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigator Initiated Study for Optimal Maintenance Treatment With Calcipotriol /Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris
The combination of calcipotriol and betamethasone dipropionate used in an ointment formulation (Daivobet® ointment) has shown to have an excellent efficacy and safety in the short-term and long-term management of psoriasis vulgaris. A newly developed gel formulation (Xamiol® gel) of calcipotriol and betamethasone dipropionate has recently been approved and marketed in Korea as a topical treatment of moderate to severe scalp psoriasis and non-scalp psoriasis vulgaris.
Xamiol® gel, the investigational product (IP) used in this study, prevents keratinization by normalizing the reproduction cycle of skin cells. It also relieves itching associated with psoriasis. Xamiol® gel was initially approved for treatment of moderate to severe scalp psoriasis and its label was extended to non-scalp psoriasis vulgaris in October 2012.
Since patient compliance is one of the important factors in achieving effective outcomes in the treatment of psoriasis, the once daily dosing of Xamiol® gel is expected to enhance compliance and treatment outcomes as well as to provide a safe and effective therapeutic option.
Read the detailed description
Psoriasis is a disease difficult to cure and is usually recurrent and therefore, a continued management is crucial. An evidence-based approach is important for appropriate treatments of patient with psoriasis. However, there is a lack of response data for the topical treatments in Asian patients with psoriasis, and no treatment guidelines available. Therefore, routine topical treatments, instead of patient-specific treatments, are usually applied, which may result in treatment failure. In this regard, it is imperative to conduct a study to assess topical treatments in Korean patients with psoriasis vulgaris in terms of efficacy and side effects.
Furthermore, psoriasis patients in Korea, mostly small plaque types, may exhibit different disease activities and response outcomes and accordingly require different treatment options as compared to Western populations whose dominant psoriasis type is large plaque type. Thus, a study in Korean patients with psoriasis may reveal an interesting finding.
In order to investigate optimal maintenance regimens for the topical treatment of Korean patients with psoriasis vulgaris, we are planning this study which evaluates the efficacy of three 8-week maintenance regimens containing Xamiol® gel (PRN treatment group, Continuous treatment group and Twice weekly treatment group) in patients who have become "Responder" after 8-week induction therapy with Xamiol® gel ("Responder").
The primary objective of this study is to evaluate the percentages of "Responder"* at week 16, as assessed by Investigator's Global Assessment of Disease Severity (IGA), in three different 8-week maintenance regimens of Xamiol® gel after 8-week induction treatment with Xamiol® gel in patients with psoriasis vulgaris.
- Responder is defined as subjects with "clear" or "almost clear" according to IGA.
Secondary study objectives is to evaluate efficacy, % of Relapse and time to Relapse, PGA, Patient Compliance, Safety and Quality of Life (DLQI and TSQM) in three arms with calcipotriol/betamethasone dipropionate combination gel treatment in Korean patients with chronic plaque psoriasis of the body.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Calcipotriol/betamethasone dipropionate gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriol/betamethasone dipropionate gelDrug
Also called Xamiol gel
All enrolled subjects will receive Xamiol® gel once daily for 8 weeks during the induction period and then will be assessed according to IGA at the end of 8-week induction period. Those subjects determined to be "Responder" by IGA will be randomized to one of the following three treatment groups and they will continue their therapy with randomized maintenance regimens for the duration of additional 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PRN treatment | Experimental | Group 1: PRN treatment Apply Xamiol® gel (Calcipotriol/betamethasone dipropionate gel) once daily as needed (PRN) Receives: Drug: Calcipotriol/betamethasone dipropionate gel |
| Continuous treatment | Experimental | Group 2: Continuous treatment Apply Xamiol® gel (Calcipotriol/betamethasone dipropionate gel)once daily Receives: Drug: Calcipotriol/betamethasone dipropionate gel |
| Weekends treatment | Experimental | Group 3: Weekends treatment (twice weekly) Apply Xamiol® gel (Calcipotriol/betamethasone dipropionate gel) once daily at weekends (on Saturdays and Sundays) Receives: Drug: Calcipotriol/betamethasone dipropionate gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of "Responder" (subjects with a grade of "clear" or "almost clear") according to IGA at Week 16
The primary objective of this study is to evaluate the percentages of "Responder"* at week 16, as assessed by Investigator's Global Assessment of Disease Severity (IGA), in three different 8-week maintenance regimens of Xamiol® gel after 8-week induction treatment with Xamiol® gel in patients with psoriasis vulgaris.
Measured: Week 16
Secondary outcomes (6)
Investigator's global assessment of disease severity
To evaluate the change of disease severity assessed by IGA in induction treatment phase and compare the IGA disease severity of three different maintenance regimens in the maintenance treatment phase.
Measured: Week 0, 4, 8, 12 and 16
Percentage of disease relapse
To evaluate descriptive statistics of three different regimens in the maintenance treatment phase and compare percentage of relapse in threee different regimens.
Measured: Week 0, 4, 8, 12 and 16
Patient's global assessment of disease severity
To evaluate the change of disease severity assessed by PGA in induction treatment phase and compare the PGA disease severity of three different maintenance regimens in the maintenance treatment phase.
Measured: Week 0, 4, 8, 12 and 16
Change in Psoriasis Area and Severity Index (PASI) score from Baseline to Week
To evaluate the change of PASI in induction treatment phase and compare the PASI of three different maintenance regimens in the maintenance treatment phase.
Measured: Week 0, 4, 8, 12 and 16
Percent of subjects achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI) score
To evaluate the change of PASI75 from week 4 to week 8 in induction treatment phase and compare PASI75 in three different regimens in the maintenance treatment phase.
Measured: Week 0, 4, 8, 12 and 16
Time to relapse
To evaluate descriptive statistics of three different regimens in the maintenance treatment phase and compare the time to relapse in threee different regimens.
Measured: Week 0, 4, 8, 12 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies 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
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jooheung Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jooheung Lee, Samsung Medical Center
- Investigators
- Joo-Heung Lee, MD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004574
- Sponsor's protocol ID
- KSPLK 2013-01
- Acronym
- TRIANGLE
- Status last verified
- Jun 2014
- First submitted
- 10 Nov 2013
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007 Feb 22;445(7130):866-73. doi: 10.1038/nature05663.
PubMed 17314973Lew W, Lee E, Krueger JG. Psoriasis genomics: analysis of proinflammatory (type 1) gene expression in large plaque (Western) and small plaque (Asian) psoriasis vulgaris. Br J Dermatol. 2004 Apr;150(4):668-76. doi: 10.1111/j.0007-0963.2004.05891.x.
PubMed 15099362Pariser DM, Bagel J, Gelfand JM, Korman NJ, Ritchlin CT, Strober BE, Van Voorhees AS, Young M, Rittenberg S, Lebwohl MG, Horn EJ; National Psoriasis Foundation. National Psoriasis Foundation clinical consensus on disease severity. Arch Dermatol. 2007 Feb;143(2):239-42. doi: 10.1001/archderm.143.2.239.
PubMed 17310004Kragballe K, Austad J, Barnes L, Bibby A, de la Brassinne M, Cambazard F, Fleming C, Heikkila H, Williams Z, Peyri Rey J, Svensson A, Toole J, Wozel G. Efficacy results of a 52-week, randomised, double-blind, safety study of a calcipotriol/betamethasone dipropionate two-compound product (Daivobet/Dovobet/Taclonex) in the treatment of psoriasis vulgaris. Dermatology. 2006;213(4):319-26. doi: 10.1159/000096069.
PubMed 17135738Kragballe K, Noerrelund KL, Lui H, Ortonne JP, Wozel G, Uurasmaa T, Fleming C, Estebaranz JL, Hanssen LI, Persson LM. Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris. Br J Dermatol. 2004 Jun;150(6):1167-73. doi: 10.1111/j.1365-2133.2004.05986.x.
PubMed 15214905Langley RG, Gupta A, Papp K, Wexler D, Osterdal ML, Curcic D. Calcipotriol plus betamethasone dipropionate gel compared with tacalcitol ointment and the gel vehicle alone in patients with psoriasis vulgaris: a randomized, controlled clinical trial. Dermatology. 2011;222(2):148-56. doi: 10.1159/000323408. Epub 2011 Feb 3.
PubMed 21293107Samarasekera E, Sawyer L, Parnham J, Smith CH; Guideline Development Group. Assessment and management of psoriasis: summary of NICE guidance. BMJ. 2012 Oct 24;345:e6712. doi: 10.1136/bmj.e6712. No abstract available.
PubMed 23097521
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated Study for Optimal Maintenance Treatment With Calcipotriol /Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT02004574
- Acronym / sponsor ID
- TRIANGLE / KSPLK 2013-01
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Jooheung LeeUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Dec 2013 (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.
The combination of calcipotriol and betamethasone dipropionate used in an ointment formulation (Daivobet® ointment) has shown to have an excellent efficacy and safety in the short-term and long-term management of psoriasis vulgaris. A newly developed gel formulation (Xamiol® gel) of calcipotriol and betamethasone dipropionate has recently been approved and marketed in Korea as a topical treatment of moderate to severe scalp psoriasis and non-scalp psoriasis vulgaris.
Xamiol® gel, the investigational product (IP) used in this study, prevents keratinization by normalizing the reproduction cycle of skin cells. It also relieves itching associated with psoriasis. Xamiol® gel was initially approved for treatment of moderate to severe scalp psoriasis and its label was extended to non-scalp psoriasis vulgaris in October 2012.
Since patient compliance is one of the important factors in achieving effective outcomes in the treatment of psoriasis, the once daily dosing of Xamiol® gel is expected to enhance compliance and treatment outcomes as well as to provide a safe and effective therapeutic option.
Detailed description
Psoriasis is a disease difficult to cure and is usually recurrent and therefore, a continued management is crucial. An evidence-based approach is important for appropriate treatments of patient with psoriasis. However, there is a lack of response data for the topical treatments in Asian patients with psoriasis, and no treatment guidelines available. Therefore, routine topical treatments, instead of patient-specific treatments, are usually applied, which may result in treatment failure. In this regard, it is imperative to conduct a study to assess topical treatments in Korean patients with psoriasis vulgaris in terms of efficacy and side effects.
Furthermore, psoriasis patients in Korea, mostly small plaque types, may exhibit different disease activities and response outcomes and accordingly require different treatment options as compared to Western populations whose dominant psoriasis type is large plaque type. Thus, a study in Korean patients with psoriasis may reveal an interesting finding.
In order to investigate optimal maintenance regimens for the topical treatment of Korean patients with psoriasis vulgaris, we are planning this study which evaluates the efficacy of three 8-week maintenance regimens containing Xamiol® gel (PRN treatment group, Continuous treatment group and Twice weekly treatment group) in patients who have become "Responder" after 8-week induction therapy with Xamiol® gel ("Responder").
The primary objective of this study is to evaluate the percentages of "Responder"* at week 16, as assessed by Investigator's Global Assessment of Disease Severity (IGA), in three different 8-week maintenance regimens of Xamiol® gel after 8-week induction treatment with Xamiol® gel in patients with psoriasis vulgaris.
- Responder is defined as subjects with "clear" or "almost clear" according to IGA.
Secondary study objectives is to evaluate efficacy, % of Relapse and time to Relapse, PGA, Patient Compliance, Safety and Quality of Life (DLQI and TSQM) in three arms with calcipotriol/betamethasone dipropionate combination gel treatment in Korean patients with chronic plaque psoriasis of the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRN treatment | Experimental | Drug: Calcipotriol/betamethasone dipropionate gelGroup 1: PRN treatment Apply Xamiol® gel (Calcipotriol/betamethasone dipropionate gel) once daily as needed (PRN) |
| Continuous treatment | Experimental | Drug: Calcipotriol/betamethasone dipropionate gelGroup 2: Continuous treatment Apply Xamiol® gel (Calcipotriol/betamethasone dipropionate gel)once daily |
| Weekends treatment | Experimental | Drug: Calcipotriol/betamethasone dipropionate gelGroup 3: Weekends treatment (twice weekly) Apply Xamiol® gel (Calcipotriol/betamethasone dipropionate gel) once daily at weekends (on Saturdays and Sundays) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged 19 years and above
- Clinical diagnosis of stable psoriasis vulgaris of at least 4 weeks duration involving the non-scalp regions of the body (trunk and/or limbs) amenable to treatment with a maximum of 100 g of topical medication per week at screening
- An investigator's global assessment of disease severity(IGA) of at least mild on the body (trunk and/or limbs) at Day 0 (Baseline)
- Signed written informed consent prior to performance of any study-specific procedures or assessments, and must be willing to comply with treatment and follow up
- Able to communicate with the investigator and understand and comply with the requirements of the study
Key exclusion criteria (28 listed)
- Body surface area (BSA) > 10 % or Psoriasis Area and Severity Index (PASI) > 10 at baseline
- Subjects with unstable forms of psoriasis including guttate, erythrodermic, exfoliative and pustular psoriasis, or psoriatic arthritis
- Subjects with known disorders of calcium metabolism/hypercalcemia
- Subjects with hypersensitivity to the active substances or to any of the excipients of the investigational products
- Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within the following time periods prior to baseline visit
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 |
|---|---|---|
| Calcipotriol/betamethasone dipropionate gelAlso: Xamiol gelAll enrolled subjects will receive Xamiol® gel once daily for 8 weeks during the induction period and then will be assessed according to IGA at the end of 8-week induction period. Those subjects determined to be "Responder" by IGA will be randomized to one of the following three treatment groups and they will continue their therapy with randomized maintenance regimens for the duration of additional 8 weeks. | Drug | Continuous treatment, PRN treatment, Weekends treatment |
Primary outcome
Percentage of "Responder" (subjects with a grade of "clear" or "almost clear") according to IGA at Week 16
Time frame: Week 16
The primary objective of this study is to evaluate the percentages of "Responder"* at week 16, as assessed by Investigator's Global Assessment of Disease Severity (IGA), in three different 8-week maintenance regimens of Xamiol® gel after 8-week induction treatment with Xamiol® gel in patients with psoriasis vulgaris.
6 secondary outcomes
Investigator's global assessment of disease severity
Time frame: Week 0, 4, 8, 12 and 16
Percentage of disease relapse
Time frame: Week 0, 4, 8, 12 and 16
Patient's global assessment of disease severity
Time frame: Week 0, 4, 8, 12 and 16
Change in Psoriasis Area and Severity Index (PASI) score from Baseline to Week
Time frame: Week 0, 4, 8, 12 and 16
Percent of subjects achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI) score
Time frame: Week 0, 4, 8, 12 and 16
Time to relapse
Time frame: Week 0, 4, 8, 12 and 16
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 4 Jun 2014.
- Results publication: PubMed 17314973Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007 Feb 22;445(7130):866-73. doi: 10.1038/nature05663.
- Results publication: PubMed 15099362Lew W, Lee E, Krueger JG. Psoriasis genomics: analysis of proinflammatory (type 1) gene expression in large plaque (Western) and small plaque (Asian) psoriasis vulgaris. Br J Dermatol. 2004 Apr;150(4):668-76. doi: 10.1111/j.0007-0963.2004.05891.x.
- Results publication: PubMed 17310004Pariser DM, Bagel J, Gelfand JM, Korman NJ, Ritchlin CT, Strober BE, Van Voorhees AS, Young M, Rittenberg S, Lebwohl MG, Horn EJ; National Psoriasis Foundation. National Psoriasis Foundation clinical consensus on disease severity. Arch Dermatol. 2007 Feb;143(2):239-42. doi: 10.1001/archderm.143.2.239.
- Results publication: PubMed 17135738Kragballe K, Austad J, Barnes L, Bibby A, de la Brassinne M, Cambazard F, Fleming C, Heikkila H, Williams Z, Peyri Rey J, Svensson A, Toole J, Wozel G. Efficacy results of a 52-week, randomised, double-blind, safety study of a calcipotriol/betamethasone dipropionate two-compound product (Daivobet/Dovobet/Taclonex) in the treatment of psoriasis vulgaris. Dermatology. 2006;213(4):319-26. doi: 10.1159/000096069.
- Results publication: PubMed 15214905Kragballe K, Noerrelund KL, Lui H, Ortonne JP, Wozel G, Uurasmaa T, Fleming C, Estebaranz JL, Hanssen LI, Persson LM. Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris. Br J Dermatol. 2004 Jun;150(6):1167-73. doi: 10.1111/j.1365-2133.2004.05986.x.
- Results publication: PubMed 21293107Langley RG, Gupta A, Papp K, Wexler D, Osterdal ML, Curcic D. Calcipotriol plus betamethasone dipropionate gel compared with tacalcitol ointment and the gel vehicle alone in patients with psoriasis vulgaris: a randomized, controlled clinical trial. Dermatology. 2011;222(2):148-56. doi: 10.1159/000323408. Epub 2011 Feb 3.
- Results publication: PubMed 23097521Samarasekera E, Sawyer L, Parnham J, Smith CH; Guideline Development Group. Assessment and management of psoriasis: summary of NICE guidance. BMJ. 2012 Oct 24;345:e6712. doi: 10.1136/bmj.e6712. No abstract available.
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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.
Joo-Heung Lee, MD study chair
Samsung Medical Center
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 Calcipotriol/betamethasone dipropionate gel in people with Psoriasis Vulgaris, run by Jooheung Lee at 1 site in South Korea.
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 6 inclusion and 28 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 4 Jun 2014. 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 South Korea. 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?
Percentage of "Responder" (subjects with a grade of "clear" or "almost clear") according to IGA at Week 16 (time frame: Week 16). 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 NCT02004574, which also lists 7 linked publications.
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 4 Jun 2014.