Safety and Efficacy of LEO 80185 Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

Scalp Psoriasis Clinical Trial

Official title:

Safety and Efficacy of Calcipotriol Plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120223
• Other study ID #: MBL 0412 INT
• Secondary ID: 2008-005456-24
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2010
• Last updated: March 25, 2015
• Start date: May 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp® Topical Suspension for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• A clinical diagnosis of scalp psoriasis which is of an extent of more than or equal to 10% of the scalp area

• A clinical diagnosis of scalp psoriasis which is of at least moderate severity according to the investigator's global assessment

• Serum albumin-corrected calcium below the upper reference limit at screening visit 2

Exclusion Criteria:

• A history of hypersensitivity to any component of the LEO 80185 gel

• Topical treatment on the trunk and/or limbs with very potent (WHO group IV) corticosteroids within 2 weeks prior to Visit 1 or during the study

• Topical treatment on the face and/or genital/skin folds with potent or very potent (WHO groups III-IV) corticosteroids within 2 weeks prior to Visit 1 or during the study

• Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis within the following time period prior to Visit 1 and during the study:

• etanercept - within 4 weeks prior to Visit 1

• adalimumab, alefacept, infliximab - within 2 months prior to Visit 1

• ustekinumab - within 4 months prior to Visit 1

• experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1

• Systemic treatment with therapies other than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the study

• UVB therapy within 2 weeks prior to Visit 1 or during the study

• Any topical treatment on the scalp (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the study

• Systemic calcium or vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to screening visit 2 or during the study

• Planned initiation of, or changes to, concomitant medication that could affect scalp psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the study

• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

• Subjects with any of the following conditions present on the scalp 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, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds

• Planned excessive exposure to sun during the study that may affect scalp psoriasis

• Known or suspected disorders of calcium metabolism associated with hypercalcaemia

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
Once daily application

Locations

Country	Name	City	State
Canada	UltraNova Skincare	Barrie	Ontario
Canada	Kirk Barber Research	Calgary	Alberta
Canada	The Guenther Dermatology Research Centre	London	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	The Centre for Dermatology and Cosmetic Surgery	Richmond Hill	Ontario
Canada	Royal University Hospital, Division of Dermatology	Saskatoon	Saskatchewan
Canada	Winnipeg Clinic Dermatology Research	Winnipeg	Manitoba
France	CHU Saint-Etienne - Hôpital Nord, Service de Dermatologie	Saint-Etienne
United Kingdom	Monklands Hospital	Airdrie	Lanarkshire
United Kingdom	City Hospital	Birmingham
United Kingdom	Burbage Surgery	Burbage	Leicestershire
United Kingdom	Harrogate District Hospital	Harrogate	North Yorkshire
United Kingdom	Leeds General Infirmary	Leeds	W. Yorkshire
United Kingdom	Whipps Cross University Hospital	Leytonstone	London
United Kingdom	Royal Gwent Hospital	Newport
United Kingdom	Hope Hospital	Salford	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Canada,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Adverse Drug Reactions (ADRs)	Adverse events for which the investigator did not describe the causal relationship to IP as not related	Throughout trial, up to 8-weeks	Yes
Primary	Change in Albumincorrected Serum Calcium From Baseline to Week 4	Change in albumincorrected serum calcium from Baseline to week 4	Baseline and week 4	Yes
Primary	Change in Albumincorrected Serum Calcium From Baseline to Week 8	Change in albumincorrected serum calcium from Baseline to week 8	Baseline and week 8	Yes
Primary	Change in Albumincorrected Serum Calcium From Baseline to End of Treatment	Change in albumincorrected serum calcium from Baseline to end of treatment	Baseline and End of treatment (up to 8 weeks)	Yes
Primary	Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4	Change in 24-hour urinary calcium excretion from Baseline to week 4	Baseline and week 4	Yes
Primary	Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8	Change in 24-hour urinary calcium excretion from Baseline to week 8	Baseline and week 8	Yes
Primary	Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment	Change in 24-hour urinary calcium excretion from Baseline to end of treatment	Baseline and End of treatment (up to 8 weeks)	Yes
Primary	Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4	Change in urinary calcium:creatinine ratio from Baseline to week 4	Baseline and week 4	Yes
Primary	Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8	Change in urinary calcium:creatinine ratio from Baseline to week 8	Baseline and week 8	Yes
Primary	Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment	Change in urinary calcium:creatinine ratio from Baseline to end of treatment	Baseline and End of treatment (up to 8 weeks)	Yes
Secondary	Change in Plasma PTH From Baseline to Week 4	Change in plasma PTH (parathyroid hormone) from Baseline to week 4	Baseline and week 4	Yes
Secondary	Change in Plasma PTH From Baseline to Week 8	Change in plasma PTH (parathyroid hormone) from Baseline to week 8	Baseline and week 8	Yes
Secondary	Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2	Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 2. The IGA Scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.	Week 2	No
Secondary	Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4	Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 4	Week 4	No
Secondary	Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8	Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 8	Week 8	No
Secondary	Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at End of Treatment	Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at end of treatment	End of treatment (up to 8 weeks)	No
Secondary	Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2	Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).	Baseline and week 2	No
Secondary	Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4	Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 to 12 points.	Baseline and week 4	No
Secondary	Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8	Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).	Baseline and week 8	No
Secondary	Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment.	Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).	Baseline and End of treatment (up to 8 weeks)	No
Secondary	Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2	Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale: 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.	Week 2	No
Secondary	Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4	Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.	Week 4	No
Secondary	Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8	Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.	Week 8	No
Secondary	Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment	Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.	End of treatment (up to 8 weeks)	No
Secondary	Withdrawal	How many subjects withdrew from the study. Reasons for withdrawal: due to exclusion criteria emerging, due to AE(s), or due to other reason	Week 4 and 8	Yes

External Links

•   Clinical Trials at LEO Pharma