A Plaque Test Comparing the Anti-psoriatic Effect of Marketed Products for Topical Use for Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

A Plaque Test Comparing 4 Steroids With Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845481
• Other study ID #: PLQ-002
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2009
• Last updated: March 25, 2015
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: (in summary)

• Subjects having understood and signed an informed consent form

• All skin types

• Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable

• Subjects willing and able to follow all the study procedures and complete the whole study

• Subjects affiliated to social security system

Exclusion Criteria: (in summary)

• Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding

• Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration

• Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation

• Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy

• Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy

• Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Daivobet® ointment
Once daily application 6 days a week for 3 weeks
• Betnovat® ointment
Once daily application 6 days a week for 3 weeks
• Diprosalic ointment
Once daily application 6 days a week for 3 weeks
• Dermovat ointment
Once daily application 6 days a week for 3 weeks
• Elocon ointment
Once daily application 6 days a week for 3 weeks
• Daivobet® ointment vehicle
Once daily application 6 days a week for 3 weeks

Locations

Country	Name	City	State
France	LEO Pharma site	St Quentin Yvelines Cedex

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)	Baseline and 3 weeks	No
Primary	The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)	Baseline and 3 weeks	No
Primary	The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)	Baseline and 3 weeks	No
Primary	The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)	Baseline and 3 weeks	No
Primary	The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)	Baseline and 3 weeks	No
Primary	The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)	Baseline and 3 weeks	No

External Links

•   Clinical Trials at LEO Pharma