A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products

NCT00875277 | Completed Phase 2 Results

• 1 other identifier: PLQ-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)

  The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).

  From baseline (Day 1) to end of treatment (Day 29)

Secondary Outcomes (12)

• Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline

  From baseline (Day 1) to end of treatment (Day 29)

• Change in Erythema Compared to Baseline

  At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25

• Change in Scaling Compared to Baseline

  At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

• Change in Infiltration Compared to Baseline

  At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

• Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline

  At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

Study Arms (6)

LEO 29102 cream

EXPERIMENTAL

LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks

Drug: LEO 29102 cream

LEO 29102 Cream Vehicle

PLACEBO COMPARATOR

LEO 29102 cream vehicle applied topically twice daily for 4 weeks.

Drug: LEO 29102 Cream Vehicle

Betamethasone Dipropionate Cream

EXPERIMENTAL

Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.

Drug: Betamethasone Dipropionate Cream

LEO 29102 Plus Calcipotriol Cream

EXPERIMENTAL

LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.

Drug: LEO 29102 Plus Calcipotriol Cream

LEO 29102 Plus Betamethasone Dipropionate

EXPERIMENTAL

LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.

Drug: LEO 29102 Plus Betamethasone Dipropionate

Daivobet® Ointment

ACTIVE COMPARATOR

Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.

Drug: Daivobet® Ointment

Interventions

LEO 29102 cream DRUG

LEO 29102 cream

LEO 29102 Cream Vehicle DRUG

LEO 29102 Cream Vehicle

Betamethasone Dipropionate Cream DRUG

Betamethasone Dipropionate Cream

LEO 29102 Plus Calcipotriol Cream DRUG

LEO 29102 Plus Calcipotriol Cream

LEO 29102 Plus Betamethasone Dipropionate DRUG

LEO 29102 Plus Betamethasone Dipropionate

Daivobet® Ointment DRUG

Daivobet® Ointment

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 site

Saint-Quentin-en-Yvelines, France

Location

MeSH Terms

Interventions

2-(6-(2-(3,5-dichloro-4-pyridyl)acetyl)-2,3-dimethoxyphenoxy)-N-propylacetamide; betamethasone-17,21-dipropionate

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Director, International Clinical Development, MD

  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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 12, 2025
• Results First Posted: December 11, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)