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

NCT00578370 | Completed Phase 1

• 2 other identifiers: ISD001-CI-072007-002947-26
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Psoriatic infiltrate measured by sonography

  26 days

Secondary Outcomes (1)

• Skin condition measured by scoring

  26 days

Study Arms (5)

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

Interventions

Ciclosporin 0.5% (Formulation 01B) DRUG

Cutaneous emulsion 200µl once a day (26 days)

1

Ciclosporin 1.5% (Formulation 02B) DRUG

Cutaneous emulsion 200µl once a day (26 days)

2

0.1% betamethasone DRUG

Solution 200µl once a day (26 days)

Also known as: Betnesol V crinale 0.1%

3

0.005% calcipotriol DRUG

Solution 200µl once a day (26 days)

Also known as: Daivonex solution 0.005%

4

Formulation 00B DRUG

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

5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ISDIN: lead

Study Sites (1)

Bioskin

Hamburg, Hamburg, 20095, Germany

Location

Related Publications (2)

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

  PMID: 4111105 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Cyclosporine; Betamethasone; calcipotriene

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Johannes Gassmueller, MD

  Bioskin GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 21, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: November 5, 2008

Record last verified: 2008-11

Locations

DE (1)