Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

A Clinical Trial Gathering Insight of Patient Reported Factors That Influence Preference Following Once Daily Topical Treatment With LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310646
• Other study ID #: LP0053-1030
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2014
• Last updated: August 31, 2015
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: June 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

Description:

An international, multi-centre, prospective, open-label, randomised, 2-arm, cross-over study with 14-days once daily treatment in subjects with psoriasis vulgaris. To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion:

1. At Day 1 (Visit 1), a clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs amenable to treatment with a maximum of 60 g of study medication per week

2. Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA) at Day 1 (Visit 1)

3. A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and/or limbs at Day 1 (Visit 1)

4. A modified PASI (m-PASI) score of at least 2 on the trunk and/or limbs at Day 1 (Visit 1)

Exclusion:

1. Topical anti-psoriatic treatment on the trunk and limbs within 2 weeks prior to randomisation.

2. Any previous topical treatment with calcipotriol plus betamethasone gel (Daivobet® gel or Xamiol® gel).

3. Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation.

4. Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation.

5. Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps etc.) during the trial.

6. Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.

7. Previously randomised into a clinical trial involving LEO 90100.

8. Current participation in any other interventional clinical trial.

9. Previously randomised into this trial.

10. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.

11. Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ulcers and wounds.

12. Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis.

13. Known or suspected disorders of calcium metabolism associated with hypercalcaemia.

14. Known or suspected severe renal insufficiency or severe hepatic disorders.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• LEO 90100 Aerosol Foam
Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week
• Daivobet® gel
Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week.

Locations

Country	Name	City	State
Canada	K.Papp Clinical Research Inc.	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall treatment preference by Subject's Preference Assessment (SPA) at week 2 and association with baseline characteristics	Overall preference (foam or gel) by baseline characteristics	2 weeks	No
Primary	Within subject difference in response to Topical Product Usability Questionnaire (TPUQ) and Vehicle Preference Measure (VPM) items between trial treatments	Within subject comparison of product attributes between trial treatments (foam or gel).	2 weeks	No
Primary	Within subject difference in response to Topical Product Usability Questionnaire (TPUQ) between the last topical anti-psoriatic treatment and each of the two trial treatments	Within subject comparison of product attributes between trial treatments (foam or gel) and the last topical anti-psoriatic product used prior to joining the trial.	2 weeks	No
Primary	Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for each of the two trial treatments (foam or gel)	Comparison between the trial treatments (foam or gel) and last topical anti-psoriatic product used prior to joining the trial given as preference to each product for given attributes	2 weeks	No
Primary	Reasons for overall preference as assessed by Subject's Preference Assessment (SPA) at week 2	Comparison of contribution of each product attribute in the stated preference between trial treatments (foam and gel)	2 weeks	No