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

Phase 2

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: Daivobet® ointment; Drug: Betnovat® ointment; Drug: Diprosalic ointment; Drug: Dermovat ointment; Drug: Elocon ointment; Drug: Daivobet® ointment vehicle

• Registration Number: NCT00845481
• Lead Sponsor: LEO Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-16
• Study First Submitted QC: 2009-02-16
• Study First Posted: 2009-02-18
• Primary Completion: 2009-03
• Study Completion: 2009-05
• Results First Submitted: 2011-01-13
• Results First Submitted QC: 2011-02-14
• Results First Posted: 2011-03-08
• Status Verified: 2015-03
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
all patients apply all products	Betnovat® ointment	-
all patients apply all products	Dermovat ointment	-
all patients apply all products	Daivobet® ointment vehicle	-
all patients apply all products	Daivobet® ointment	-
all patients apply all products	Diprosalic ointment	-
all patients apply all products	Elocon ointment	-

Primary Outcome Measures

Name	Time	Method
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment	Baseline and 3 weeks	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment	Baseline and 3 weeks	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment	Baseline and 3 weeks	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment	Baseline and 3 weeks	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment	Baseline and 3 weeks	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle	Baseline and 3 weeks	The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

Trial Locations

Locations (1)

LEO Pharma Investigational Site; 🇫🇷 Saint Quentin Yvelines Cedex, France