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Efficacy and Tolerability Study of Topical Ciclosporin in a Psoriasis Plaque Test

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Ciclosporin 0.5% (Formulation 01B)

Ciclosporin 1.5% (Formulation 02B)

0.1% betamethasone

0.005% calcipotriol

Formulation 00B

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Ciclosporin, Plaque type psoriasis, Psoriasis plaque test, Sonography, Cyclosporin, Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Bioskin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Psoriatic infiltrate measured by sonography

Secondary Outcome Measures

Skin condition measured by scoring

Full Information

NCT ID

NCT00578370

First Posted

December 20, 2007

Last Updated

November 4, 2008

Sponsor

ISDIN

1. Study Identification

Unique Protocol Identification Number

NCT00578370

Brief Title

Efficacy and Tolerability Study of Topical Ciclosporin in a Psoriasis Plaque Test

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

ISDIN

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Ciclosporin, Plaque type psoriasis, Psoriasis plaque test, Sonography, Cyclosporin, Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ciclosporin 0.5% (Formulation 01B)

Intervention Description

Cutaneous emulsion 200µl once a day (26 days)

Intervention Type

Drug

Intervention Name(s)

Ciclosporin 1.5% (Formulation 02B)

Intervention Description

Cutaneous emulsion 200µl once a day (26 days)

Intervention Type

Drug

Intervention Name(s)

0.1% betamethasone

Other Intervention Name(s)

Betnesol V crinale 0.1%

Intervention Description

Solution 200µl once a day (26 days)

Intervention Type

Drug

Intervention Name(s)

0.005% calcipotriol

Other Intervention Name(s)

Daivonex solution 0.005%

Intervention Description

Solution 200µl once a day (26 days)

Intervention Type

Drug

Intervention Name(s)

Formulation 00B

Intervention Description

Cutaneous emulsion (Vehicle to Formulation 01B and Formulation 02B) 200µl once a day (26 days)

Primary Outcome Measure Information:

Title

Psoriatic infiltrate measured by sonography

Time Frame

26 days

Secondary Outcome Measure Information:

Title

Skin condition measured by scoring

Time Frame

26 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johannes Gassmueller, MD

Organizational Affiliation

Bioskin GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bioskin

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

4111105

Citation

Dumas KJ, Scholtz JR. The psoriasis bio-assay for topical corticosteroid activity. Acta Derm Venereol. 1972;52(1):43-8. No abstract available.

Results Reference

background

Citation

Wendt 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

Results Reference

background

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Efficacy and Tolerability Study of Topical Ciclosporin in a Psoriasis Plaque Test

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