A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01580488

Enrollment

Registered

2012-04-19

Start date

2012-04-30

Completion date

2012-06-30

Last updated

2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis Vulgaris

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.

Interventions

DRUGB LEO 35299 20 mg/g cream

once daily application, 3 weeks

DRUGC LEO 35299 20 mg/g cream

once daily application, 3 weeks

DRUGE LEO 35299 10 mg/g solution

once daily application, 3 weeks

DRUGF LEO 35299 10 mg/g solution

once daily application, 3 weeks

DRUGDaivonex® ointment

once daily application, 3 weeks

DRUGDaivonex® ointment vehicle

once daily application, 3 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 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. 2. Age 18 years or above. 3. Males, or females of non-child bearing potential. 4. Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).

Exclusion criteria

1. 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. 2. Female subjects who are pregnant, of child-bearing potential or who are breast feeding. 3. 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. 4. 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. 5. 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. 6. Subjects using of phototherapy within the following time periods prior to randomisation and during the study: * PUVA (4 weeks) * UVB (2 weeks) 7. 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 * Tar, * Salicylic acid. 8. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis 9. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview 10. Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments) 11. Subjects with current participation in any other interventional clinical, based on interview of the subject

Design outcomes

Primary

Measure	Time frame	Description
Change in the Total Clinical Score From Baseline to Day 22	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)

Secondary

Measure	Time frame	Description
Change in Erythema From Baseline to Day 22	Baseline to Day 22	Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Change in Infiltration From Baseline to Day 22	Baseline to Day 22	Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Change in Scaling From Baseline to Day 22	Baseline to Day 22	Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent).
Change in Lesion Thickness From Baseline to Day 22	Baseline to Day 22	Change in total skin thickness measured by ultrasound from baseline to end of treatment
Change in Skin Thickness From Baseline to Day 22	Baseline to Day 22	Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment

Countries

France

Participant flow

Recruitment details

First subject first visit, start date: 24-Apr-2012 Last subject last visit, completion date: 05-Jun-2012

Pre-assignment details

Prior to randomisation, the subjects entered a washout phase of up to 21 days (if required) where antipsoriatic treatment and other relevant medications or treatments had to be discontinued as defined by the exclusion criteria

Participants by arm

Arm	Count
All Study Participants	24
Total	24

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	All Study Participants
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	1 Participants
Age, Categorical Between 18 and 65 years	23 Participants
Age, Continuous	47.8 years STANDARD_DEVIATION 11.1
Region of Enrollment France	24 participants
Sex: Female, Male Female	5 Participants
Sex: Female, Male Male	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 24	0 / 24	0 / 24	0 / 24	2 / 24	1 / 24
serious Total, serious adverse events	0 / 24	0 / 24	0 / 24	0 / 24	0 / 24	0 / 24

Outcome results

Primary

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)