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

NCT02310646 | Completed Phase 3 Results

• 1 other identifier: LP0053-1030
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics

  The SPA questionnaire was completed at Week 2 and consisted of 2 parts: (i) the subject indicated if they preferred LEO 90100 foam or Daivobet® gel based on their experience using these products for 1 week each during the 2-weeks treatment period; (ii) the subject indicated how much each of the 22 items under the application, formulation, and container domains contributed to their overall decision of which product they preferred. This part of the SPA tool used a 4-point scale ranging from 'very important factor' to 'not at all important factor'. The statistical significance of each of the following 7 baseline characteristics (gender, age, disease severity, distribution, plaque size, skin thickness, onset) was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Results of multiple regression analyses are provided in the Clinical Study Report which can be found on the LEO Pharma website.

  2 weeks

Other Outcomes (5)

• Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments

  2 weeks

• Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments

  Baseline to Week 2

• Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel)

  At Week 1 and Week 2

Study Arms (2)

Treatment group 1

ACTIVE COMPARATOR

Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel

Drug: LEO 90100 Aerosol Foam; Drug: Daivobet® gel

Treatment group 2

ACTIVE COMPARATOR

Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam

Drug: LEO 90100 Aerosol Foam; Drug: Daivobet® gel

Interventions

LEO 90100 Aerosol Foam DRUG

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

Treatment group 1; Treatment group 2

Daivobet® gel DRUG

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.

Treatment group 1; Treatment group 2

Eligibility Criteria

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

You may qualify if:

• 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
• 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)
• A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and/or limbs at Day 1 (Visit 1)
• A modified PASI (m-PASI) score of at least 2 on the trunk and/or limbs at Day 1 (Visit 1)

You may not qualify if:

• Topical anti-psoriatic treatment on the trunk and limbs within 2 weeks prior to randomisation.
• Any previous topical treatment with calcipotriol plus betamethasone gel (Daivobet® gel or Xamiol® gel).
• Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation.
• Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation.
• 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.
• 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.
• Previously randomised into a clinical trial involving LEO 90100.
• Current participation in any other interventional clinical trial.
• Previously randomised into this trial.
• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
• 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.
• Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis.
• Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
• Known or suspected severe renal insufficiency or severe hepatic disorders.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

K.Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1CR, Canada

Location

Related Links

• Clinical Trials at LEO Pharma

Results Point of Contact

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

ctr.disclosure@leo-pharma.com

+45 44945888

Study Officials

• Kim Papp, MD phD

  K. Papp Clinical Research INC.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: December 8, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 10, 2025
• Results First Posted: December 28, 2016

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)