A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

NCT01580488 | Completed Phase 1 Results

• 2 other identifiers: PLQ-0082011-005349-11
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Change in the Total Clinical Score From Baseline to Day 22

  Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe)

  Baseline to Day 22

Secondary Outcomes (5)

• Change in Erythema From Baseline to Day 22

  Baseline to Day 22

• Change in Infiltration From Baseline to Day 22

  Baseline to Day 22

• Change in Scaling From Baseline to Day 22

  Baseline to Day 22

• Change in Lesion Thickness From Baseline to Day 22

  Baseline to Day 22

• Change in Skin Thickness From Baseline to Day 22

  Baseline to Day 22

Interventions

B LEO 35299 20 mg/g cream DRUG

once daily application, 3 weeks

C LEO 35299 20 mg/g cream DRUG

once daily application, 3 weeks

E LEO 35299 10 mg/g solution DRUG

once daily application, 3 weeks

F LEO 35299 10 mg/g solution DRUG

once daily application, 3 weeks

Daivonex® ointment DRUG

once daily application, 3 weeks

Daivonex® ointment vehicle DRUG

once daily application, 3 weeks

Eligibility Criteria

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

You may qualify if:

• Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
• Age 18 years or above.
• Males, or females of non-child bearing potential.
• Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).

You may not qualify if:

• Male subjects who are not willing to use a local contraception (such as condom) from the time of study entry and for three months following the last study drug application.
• Female subjects who are pregnant, of child-bearing potential or who are breast feeding.
• Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months(adalimumab, alefacept, infliximab), 4 months(ustekinumab) or 4 weeks/5 half-lives (which-ever islonger) for experimental biological products prior to randomisation and during the study.
• Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immune suppressants) within the 4-week period prior to randomisation and during the study.
• Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:
• \- Potent or very potent (WHO group III-IV) corticosteroids.
• Subjects using of phototherapy within the following time periods prior to randomisation and during the study:
• PUVA (4 weeks)
• UVB (2 weeks)
• Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:
• WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
• Topical retinoids
• Vitamin D analogues
• Topical immunomodulators (e.g. macrolides)
• Anthracen derivatives

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière

Nice, 06202, France

Location

MeSH Terms

Interventions

Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Limitations and Caveats

This was an exploratory study in which each of the 24 subjects received all 6 treatments on 2 cm diameter dermal test sites. Regarding Adverse Events, only local dermal reactions could be potentially attributed to a specific treatment.

Results Point of Contact

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

ctr.disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Catherine Queille-Roussel, MD

  Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière 06202 Nice Cedex 3, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 19, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 12, 2025
• Results First Posted: December 30, 2013

Record last verified: 2013-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)