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

NCT00845481 | Completed Phase 2 Results

• 1 other identifier: PLQ-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

all patients apply all products

EXPERIMENTAL

Drug: Daivobet® ointment; Drug: Betnovat® ointment; Drug: Diprosalic ointment; Drug: Dermovat ointment; Drug: Elocon ointment; Drug: Daivobet® ointment vehicle

Interventions

Daivobet® ointment DRUG

Once daily application 6 days a week for 3 weeks

all patients apply all products

Betnovat® ointment DRUG

Once daily application 6 days a week for 3 weeks

all patients apply all products

Diprosalic ointment DRUG

Once daily application 6 days a week for 3 weeks

all patients apply all products

Dermovat ointment DRUG

Once daily application 6 days a week for 3 weeks

all patients apply all products

Elocon ointment DRUG

Once daily application 6 days a week for 3 weeks

all patients apply all products

Daivobet® ointment vehicle DRUG

Once daily application 6 days a week for 3 weeks

all patients apply all products

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

LEO Pharma Investigational Site

Saint Quentin Yvelines Cedex, 78054, France

Location

Related Links

• Clinical Trials at LEO Pharma

Results Point of Contact

• Title: Torsten Skov, Senior Medical Advisor
• Organization: LEO Pharma

torsten.skov@leo-pharma.com

+45 20 73 62 94

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: January 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 12, 2025
• Results First Posted: March 8, 2011

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)