PsoriasisPhase 1/2NCT00578370
Efficacy and Tolerability Study of Topical Ciclosporin in a Psoriasis Plaque Test
A Phase 1/2 study testing Ciclosporin 0.5% (Formulation 01B), Ciclosporin 1.5% (Formulation 02B) and 0.1% betamethasone in people with Psoriasis, run by ISDIN at 1 site in Germany.
Trial summary
Ciclosporin is a cyclic nonribosomal polypeptide of 11 amino acids produced by the fungi Tolypocladium inflatum and Cylindrocarpon lucidum. Ciclosporin is a highly efficient immunosuppressant drug widely used in post-allergenic organ transplant to reduce the activity of the subject's immune system and so the risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Ciclosporin 0.5% (Formulation 01B), Ciclosporin 1.5% (Formulation 02B) and 0.1% betamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Apr 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with chronic plaque type psoriasis
- Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen
Who cannot join
- Local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks)
- Systemic treatment with antipsoriatics or therapy with PUVA, selected ultraviolet photo therapy in the three months preceding and during the study
- Treatment with systemic or locally acting medications which might counter or influence the study aim
- Previous therapy with methotrexate over many years
- Therapy with nephrotoxic medication
- Therapy with digoxin, colchicin and statins
Show all 13Show fewer
- Medications which might influence the potassium metabolism
- Subjects with known dysfunction of the calcium metabolism
- Subjects with increased uric acid or potassium serum levels
- Erythrodermic psoriasis, psoriasis punctata and pustular psoriasis or extended chronic stationary forms of psoriasis
- Subjects with acute virus infection
- Subjects with acne, anogenital pruritus, rosacea, perioral dermatitis, specific skin problems (skin tuberculosis, luetic skin diseases), vaccination reactions, skin infections caused by bacteria or viruses
- Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Center, Randomized, Vehicle-Controlled Study, Double-Blind for the Study Preparations and Observer-Blind for the Comparators to Determine the Antipsoriatic Efficacy and Tolerability of Topical Formulations With Ciclosporin in a Psoriasis Plaque Test
Ciclosporin is a cyclic nonribosomal polypeptide of 11 amino acids produced by the fungi Tolypocladium inflatum and Cylindrocarpon lucidum. Ciclosporin is a highly efficient immunosuppressant drug widely used in post-allergenic organ transplant to reduce the activity of the subject's immune system and so the risk of organ rejection. Apart from transplant medicine, ciclosporin is also used in the treatment of autoimmune diseases like psoriasis and infrequently in rheumatoid arthritis and related diseases, although it is only used in severe cases.
Ciclosporin blocks the lymphocytes, especially the T-lymphocytes, in the G0- or G1-phase of the cell cycle. Moreover it inhibits the production and release of lymphokines including interleukin 2 or the T-cell growth factor.
Read more
Generally ciclosporin is taken orally (capsule or solution)or by injection in doses of 1.5 to 5.5 mg/kg/day. In the topical cutaneous emulsion presented here, ciclosporin is available at a concentration of 0.5 and 1.5%.
The purpose of this study is the demonstration of antipsoriatic efficacy and tolerability of topical cutaneous ciclosporin in subjects with psoriasis vulgaris.
Read the detailed description
Psoriasis is a common dermatological disorder, consisting of both an inflammatory and a hyperproliferative component. Scaly, erythematous infiltrated skin lesions are indicative of psoriasis vulgaris. The disease is characterized micromorphologically by epidermal hyperplasia with incomplete differentiation, intraepidermal accumulation of polymorphonuclear neutrophils, elongated papillae containing dilated, tortuous capillaries and lymphohistiocytic infiltrate.
Since the underlying cause of the disease remains unknown, causal therapy is not possible. The complex clinical picture necessitates a polypragmatic therapeutic approach. Typical therapies include phototherapy and photochemotherapy, topical treatment with corticosteroids, vitamin D3 analogs, coal-tar preparations and dithranol, and systemic treatment with retinoids, methotrexate and ciclosporin (oral or injection).
In the present study the topical cutaneous ciclosporin formulation for topical treatment of psoriasis will be tested in low-dose for efficacy and tolerability. Two concentrations of the ciclosporin formulation (0.5% and 1.5%), the corresponding vehicle, a marketed corticoid preparation and a marketed topical Vitamin-D-analog will be tested simultaneously in the same patient. Five test fields located at the torso and at the extremities will be examined per subject, and will be treated non-occlusively on 22 study days over a period study of 26 days.
Experimental measurements (sonography) and clinical assessments will be performed at baseline and on some study days.
- Conditions
- Psoriasis
- Being tested
- Ciclosporin 0.5% (Formulation 01B), Ciclosporin 1.5% (Formulation 02B), 0.1% betamethasone, 0.005% calcipotriol, Formulation 00B
- Keywords
- Ciclosporin, Plaque type psoriasis, Psoriasis plaque test, Sonography, Cyclosporin, Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclosporin 0.5% (Formulation 01B)Drug
Cutaneous emulsion 200µl once a day (26 days)
Ciclosporin 1.5% (Formulation 02B)Drug
Cutaneous emulsion 200µl once a day (26 days)
0.1% betamethasoneDrug
Also called Betnesol V crinale 0.1%
Solution 200µl once a day (26 days)
0.005% calcipotriolDrug
Also called Daivonex solution 0.005%
Solution 200µl once a day (26 days)
Formulation 00BDrug
Cutaneous emulsion (Vehicle to Formulation 01B and Formulation 02B) 200µl once a day (26 days)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Ciclosporin 0.5% (Formulation 01B) |
| 2 | Experimental | Not described Receives: Drug: Ciclosporin 1.5% (Formulation 02B) |
| 3 | Active comparator | Not described Receives: Drug: 0.1% betamethasone |
| 4 | Active comparator | Not described Receives: Drug: 0.005% calcipotriol |
| 5 | Placebo comparator | Not described Receives: Drug: Formulation 00B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriatic infiltrate measured by sonography
Measured: 26 days
Secondary outcomes (1)
Skin condition measured by scoring
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISDIN
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johannes Gassmueller, MD, Principal investigator, Bioskin GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578370
- Sponsor's protocol ID
- ISD001-CI-07
- Other IDs
- 2007-002947-26
- Status last verified
- Nov 2008
- First submitted
- 20 Dec 2007
- Last updated
- 5 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Dumas KJ, Scholtz JR. The psoriasis bio-assay for topical corticosteroid activity. Acta Derm Venereol. 1972;52(1):43-8. No abstract available.
PubMed 4111105Wendt H, Frosch PJ. Psoriasis-Plaque Test. 31 - 35 in: Clinico-pharmacological models for the assay of topical corticoids. Wendt H, Frosch PJ (eds.) 1982, Karger Verlag, Basel
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Randomized, Vehicle-Controlled Study, Double-Blind for the Study Preparations and Observer-Blind for the Comparators to Determine the Antipsoriatic Efficacy and Tolerability of Topical Formulations With Ciclosporin in a Psoriasis Plaque Test
- ClinicalTrials.gov ID
- NCT00578370
- Acronym / sponsor ID
- ISD001-CI-07
- Conditions
- Psoriasis
- Keywords
- Ciclosporin, Plaque type psoriasis, Psoriasis plaque test, Sonography, Cyclosporin, Psoriasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- ISDINIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ciclosporin is a cyclic nonribosomal polypeptide of 11 amino acids produced by the fungi Tolypocladium inflatum and Cylindrocarpon lucidum. Ciclosporin is a highly efficient immunosuppressant drug widely used in post-allergenic organ transplant to reduce the activity of the subject's immune system and so the risk of organ rejection. Apart from transplant medicine, ciclosporin is also used in the treatment of autoimmune diseases like psoriasis and infrequently in rheumatoid arthritis and related diseases, although it is only used in severe cases.
Ciclosporin blocks the lymphocytes, especially the T-lymphocytes, in the G0- or G1-phase of the cell cycle. Moreover it inhibits the production and release of lymphokines including interleukin 2 or the T-cell growth factor.
Generally ciclosporin is taken orally (capsule or solution)or by injection in doses of 1.5 to 5.5 mg/kg/day. In the topical cutaneous emulsion presented here, ciclosporin is available at a concentration of 0.5 and 1.5%.
The purpose of this study is the demonstration of antipsoriatic efficacy and tolerability of topical cutaneous ciclosporin in subjects with psoriasis vulgaris.
Detailed description
Psoriasis is a common dermatological disorder, consisting of both an inflammatory and a hyperproliferative component. Scaly, erythematous infiltrated skin lesions are indicative of psoriasis vulgaris. The disease is characterized micromorphologically by epidermal hyperplasia with incomplete differentiation, intraepidermal accumulation of polymorphonuclear neutrophils, elongated papillae containing dilated, tortuous capillaries and lymphohistiocytic infiltrate.
Since the underlying cause of the disease remains unknown, causal therapy is not possible. The complex clinical picture necessitates a polypragmatic therapeutic approach. Typical therapies include phototherapy and photochemotherapy, topical treatment with corticosteroids, vitamin D3 analogs, coal-tar preparations and dithranol, and systemic treatment with retinoids, methotrexate and ciclosporin (oral or injection).
In the present study the topical cutaneous ciclosporin formulation for topical treatment of psoriasis will be tested in low-dose for efficacy and tolerability. Two concentrations of the ciclosporin formulation (0.5% and 1.5%), the corresponding vehicle, a marketed corticoid preparation and a marketed topical Vitamin-D-analog will be tested simultaneously in the same patient. Five test fields located at the torso and at the extremities will be examined per subject, and will be treated non-occlusively on 22 study days over a period study of 26 days.
Experimental measurements (sonography) and clinical assessments will be performed at baseline and on some study days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ciclosporin 0.5% (Formulation 01B) |
| 2 | Experimental | Drug: Ciclosporin 1.5% (Formulation 02B) |
| 3 | Active comparator | Drug: 0.1% betamethasone |
| 4 | Active comparator | Drug: 0.005% calcipotriol |
| 5 | Placebo comparator | Drug: Formulation 00B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with chronic plaque type psoriasis
- Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen
Key exclusion criteria (13 listed)
- Local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks)
- Systemic treatment with antipsoriatics or therapy with PUVA, selected ultraviolet photo therapy in the three months preceding and during the study
- Treatment with systemic or locally acting medications which might counter or influence the study aim
- Previous therapy with methotrexate over many years
- Therapy with nephrotoxic medication
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 |
|---|---|---|
| Ciclosporin 0.5% (Formulation 01B)Cutaneous emulsion 200µl once a day (26 days) | Drug | 1 |
| Ciclosporin 1.5% (Formulation 02B)Cutaneous emulsion 200µl once a day (26 days) | Drug | 2 |
| 0.1% betamethasoneAlso: Betnesol V crinale 0.1%Solution 200µl once a day (26 days) | Drug | 3 |
| 0.005% calcipotriolAlso: Daivonex solution 0.005%Solution 200µl once a day (26 days) | Drug | 4 |
| Formulation 00BCutaneous emulsion (Vehicle to Formulation 01B and Formulation 02B) 200µl once a day (26 days) | Drug | 5 |
Primary outcome
Psoriatic infiltrate measured by sonography
Time frame: 26 days
1 secondary outcome
Skin condition measured by scoring
Time frame: 26 days
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 5 Nov 2008.
- Background: PubMed 4111105Dumas KJ, Scholtz JR. The psoriasis bio-assay for topical corticosteroid activity. Acta Derm Venereol. 1972;52(1):43-8. No abstract available.
- BackgroundWendt H, Frosch PJ. Psoriasis-Plaque Test. 31 - 35 in: Clinico-pharmacological models for the assay of topical corticoids. Wendt H, Frosch PJ (eds.) 1982, Karger Verlag, Basel
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
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
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Johannes Gassmueller, MD principal investigator
Bioskin GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ciclosporin 0.5% (Formulation 01B), Ciclosporin 1.5% (Formulation 02B) and 0.1% betamethasone in people with Psoriasis, run by ISDIN at 1 site in Germany.
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 2 inclusion and 13 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 5 Nov 2008. 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 Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Psoriatic infiltrate measured by sonography (time frame: 26 days). 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 NCT00578370, which also lists 2 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 5 Nov 2008.