Trial Outcomes & Findings for A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris (NCT NCT01580488)

NCT ID: NCT01580488

Last Updated: 2025-03-12

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: Baseline to Day 22
• Results posted on: 2025-03-12

Participant Flow

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

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

Participant milestones

Measure	All Study Participants Each of the 24 subjects received all 6 investigational products on small dermal test sites: Topical cream formulation "B" containing 20 mg/g LEO 35299 Topical cream formulation "C" containing 20 mg/g LEO 35299 Topical solution formulation "E" containing 10 mg/g LEO 35299 Topical solution formulation "F" containing 10 mg/g LEO 35299 Topical ointment containing 50 mcg/g calcipotriol Topical ointment vehicle
Overall Study STARTED	24
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

All Study Participants Each of the 24 subjects received all 6 investigational products on small dermal test sites: Topical cream formulation "B" containing 20 mg/g LEO 35299 Topical cream formulation "C" containing 20 mg/g LEO 35299 Topical solution formulation "E" containing 10 mg/g LEO 35299 Topical solution formulation "F" containing 10 mg/g LEO 35299 Topical ointment containing 50 mcg/g calcipotriol Topical ointment vehicle

Overall Study Withdrawal by Subject

1

Baseline Characteristics

A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	B LEO 35299 20 mg/g n=24 Participants Topical cream formulation "B" containing 20 mg/g LEO 35299	C LEO 35299 20 mg/g n=24 Participants Topical cream formulation "C" containing 20 mg/g LEO 35299	E LEO 35299 10 mg/g n=24 Participants Topical solution formulation "E" containing 10 mg/g LEO 35299	F LEO 35299 10 mg/g n=24 Participants Topical solution formulation "F" containing 10 mg/g LEO 35299	Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment n=24 Participants Topical ointment containing 50 mcg/g calcipotriol	Daivonex® Ointment n=24 Participants Topical ointment vehicle
Change in the Total Clinical Score From Baseline to Day 22	-2.8 units on a scale Standard Deviation 1.5	-1.9 units on a scale Standard Deviation 1.5	-1.5 units on a scale Standard Deviation 1.5	-1.8 units on a scale Standard Deviation 1.7	-4.0 units on a scale Standard Deviation 1.5	-3.3 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline to Day 22

Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).

Outcome measures

Measure	B LEO 35299 20 mg/g n=24 Participants Topical cream formulation "B" containing 20 mg/g LEO 35299	C LEO 35299 20 mg/g n=24 Participants Topical cream formulation "C" containing 20 mg/g LEO 35299	E LEO 35299 10 mg/g n=24 Participants Topical solution formulation "E" containing 10 mg/g LEO 35299	F LEO 35299 10 mg/g n=24 Participants Topical solution formulation "F" containing 10 mg/g LEO 35299	Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment n=24 Participants Topical ointment containing 50 mcg/g calcipotriol	Daivonex® Ointment n=24 Participants Topical ointment vehicle
Change in Erythema From Baseline to Day 22	-0.91 units on a scale Standard Deviation 0.56	-0.67 units on a scale Standard Deviation 0.60	-0.54 units on a scale Standard Deviation 0.47	-0.70 units on a scale Standard Deviation 0.60	-1.09 units on a scale Standard Deviation 0.56	-1.07 units on a scale Standard Deviation 0.53

SECONDARY outcome

Timeframe: Baseline to Day 22

Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).

Outcome measures

Measure	B LEO 35299 20 mg/g n=24 Participants Topical cream formulation "B" containing 20 mg/g LEO 35299	C LEO 35299 20 mg/g n=24 Participants Topical cream formulation "C" containing 20 mg/g LEO 35299	E LEO 35299 10 mg/g n=24 Participants Topical solution formulation "E" containing 10 mg/g LEO 35299	F LEO 35299 10 mg/g n=24 Participants Topical solution formulation "F" containing 10 mg/g LEO 35299	Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment n=24 Participants Topical ointment containing 50 mcg/g calcipotriol	Daivonex® Ointment n=24 Participants Topical ointment vehicle
Change in Infiltration From Baseline to Day 22	-0.87 units on a scale Standard Deviation 0.59	-0.59 units on a scale Standard Deviation 0.54	-0.46 units on a scale Standard Deviation 0.58	-0.46 units on a scale Standard Deviation 0.66	-1.48 units on a scale Standard Deviation 0.55	-1.11 units on a scale Standard Deviation 0.54

SECONDARY outcome

Timeframe: Baseline to Day 22

Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent).

Outcome measures

Measure	B LEO 35299 20 mg/g n=24 Participants Topical cream formulation "B" containing 20 mg/g LEO 35299	C LEO 35299 20 mg/g n=24 Participants Topical cream formulation "C" containing 20 mg/g LEO 35299	E LEO 35299 10 mg/g n=24 Participants Topical solution formulation "E" containing 10 mg/g LEO 35299	F LEO 35299 10 mg/g n=24 Participants Topical solution formulation "F" containing 10 mg/g LEO 35299	Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment n=24 Participants Topical ointment containing 50 mcg/g calcipotriol	Daivonex® Ointment n=24 Participants Topical ointment vehicle
Change in Scaling From Baseline to Day 22	-1.09 units on a scale Standard Deviation 0.49	-0.74 units on a scale Standard Deviation 0.60	-0.61 units on a scale Standard Deviation 0.64	-0.67 units on a scale Standard Deviation 0.60	-1.52 units on a scale Standard Deviation 0.59	-1.30 units on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: Baseline to Day 22

Change in total skin thickness measured by ultrasound from baseline to end of treatment

Outcome measures

Measure	B LEO 35299 20 mg/g n=24 Participants Topical cream formulation "B" containing 20 mg/g LEO 35299	C LEO 35299 20 mg/g n=24 Participants Topical cream formulation "C" containing 20 mg/g LEO 35299	E LEO 35299 10 mg/g n=24 Participants Topical solution formulation "E" containing 10 mg/g LEO 35299	F LEO 35299 10 mg/g n=24 Participants Topical solution formulation "F" containing 10 mg/g LEO 35299	Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment n=24 Participants Topical ointment containing 50 mcg/g calcipotriol	Daivonex® Ointment n=24 Participants Topical ointment vehicle
Change in Lesion Thickness From Baseline to Day 22	-0.31 millimeters Standard Deviation 0.37	-0.18 millimeters Standard Deviation 0.31	-0.22 millimeters Standard Deviation 0.45	-0.24 millimeters Standard Deviation 0.33	-0.36 millimeters Standard Deviation 0.37	-0.38 millimeters Standard Deviation 0.36

SECONDARY outcome

Timeframe: Baseline to Day 22

Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment

Outcome measures

Measure	B LEO 35299 20 mg/g n=24 Participants Topical cream formulation "B" containing 20 mg/g LEO 35299	C LEO 35299 20 mg/g n=24 Participants Topical cream formulation "C" containing 20 mg/g LEO 35299	E LEO 35299 10 mg/g n=24 Participants Topical solution formulation "E" containing 10 mg/g LEO 35299	F LEO 35299 10 mg/g n=24 Participants Topical solution formulation "F" containing 10 mg/g LEO 35299	Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment n=24 Participants Topical ointment containing 50 mcg/g calcipotriol	Daivonex® Ointment n=24 Participants Topical ointment vehicle
Change in Skin Thickness From Baseline to Day 22	-0.40 millimeters Standard Deviation 0.56	-0.29 millimeters Standard Deviation 0.47	-0.24 millimeters Standard Deviation 0.71	-0.40 millimeters Standard Deviation 0.51	-0.57 millimeters Standard Deviation 0.57	-0.49 millimeters Standard Deviation 0.35

Adverse Events

B LEO 35299 20 mg/g

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

C LEO 35299 20 mg/g

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

E LEO 35299 10 mg/g

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

F LEO 35299 10 mg/g

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Daivonex® Ointment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	B LEO 35299 20 mg/g n=24 participants at risk Topical cream formulation "B" containing 20 mg/g LEO 35299	C LEO 35299 20 mg/g n=24 participants at risk Topical cream formulation "C" containing 20 mg/g LEO 35299	E LEO 35299 10 mg/g n=24 participants at risk Topical solution formulation "E" containing 10 mg/g LEO 35299	F LEO 35299 10 mg/g n=24 participants at risk Topical solution formulation "F" containing 10 mg/g LEO 35299	Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment n=24 participants at risk Topical ointment containing 50 mcg/g calcipotriol	Daivonex® Ointment n=24 participants at risk Topical ointment vehicle
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/24	0.00% 0/24	0.00% 0/24	0.00% 0/24	8.3% 2/24	4.2% 1/24

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Phone: +45 4494 5888

Email: ctr.disclosure@leo-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor is entitled to review and comment on publications prior to submission or presentation. Upon request of the sponsor, the investigator shall delay publication or presentation to allow for protection of the sponsors inventions and other intellectual property.
• Publication restrictions are in place

Restriction type: OTHER