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

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ClinicalTrials.gov Identifier: NCT01120223
Recruitment Status : Completed
First Posted : May 10, 2010
Results First Posted : December 1, 2014
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief 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

Condition or disease Intervention/treatment Phase
Scalp Psoriasis Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Calcipotriol Plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
Study Start Date : May 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: LEO 80185 gel once daily application Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
Once daily application




Primary Outcome Measures :
  1. Percentage of Subjects With Adverse Drug Reactions (ADRs) [ Time Frame: Throughout trial, up to 8-weeks ]
    Adverse events for which the investigator did not describe the causal relationship to IP as not related

  2. Change in Albumincorrected Serum Calcium From Baseline to Week 4 [ Time Frame: Baseline and week 4 ]
    Change in albumincorrected serum calcium from Baseline to week 4

  3. Change in Albumincorrected Serum Calcium From Baseline to Week 8 [ Time Frame: Baseline and week 8 ]
    Change in albumincorrected serum calcium from Baseline to week 8

  4. Change in Albumincorrected Serum Calcium From Baseline to End of Treatment [ Time Frame: Baseline and End of treatment (up to 8 weeks) ]
    Change in albumincorrected serum calcium from Baseline to end of treatment

  5. Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4 [ Time Frame: Baseline and week 4 ]
    Change in 24-hour urinary calcium excretion from Baseline to week 4

  6. Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8 [ Time Frame: Baseline and week 8 ]
    Change in 24-hour urinary calcium excretion from Baseline to week 8

  7. Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment [ Time Frame: Baseline and End of treatment (up to 8 weeks) ]
    Change in 24-hour urinary calcium excretion from Baseline to end of treatment

  8. Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4 [ Time Frame: Baseline and week 4 ]
    Change in urinary calcium:creatinine ratio from Baseline to week 4

  9. Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8 [ Time Frame: Baseline and week 8 ]
    Change in urinary calcium:creatinine ratio from Baseline to week 8

  10. Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment [ Time Frame: Baseline and End of treatment (up to 8 weeks) ]
    Change in urinary calcium:creatinine ratio from Baseline to end of treatment


Secondary Outcome Measures :
  1. Change in Plasma PTH From Baseline to Week 4 [ Time Frame: Baseline and week 4 ]
    Change in plasma PTH (parathyroid hormone) from Baseline to week 4

  2. Change in Plasma PTH From Baseline to Week 8 [ Time Frame: Baseline and week 8 ]
    Change in plasma PTH (parathyroid hormone) from Baseline to week 8

  3. Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2 [ Time Frame: 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.

  4. Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4 [ Time Frame: 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

  5. Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8 [ Time Frame: 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

  6. 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 [ Time Frame: End of treatment (up to 8 weeks) ]
    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

  7. 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 [ Time Frame: Baseline and 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).

  8. 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 [ Time Frame: Baseline and week 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.

  9. 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 [ Time Frame: Baseline and 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).

  10. 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. [ Time Frame: Baseline and End of treatment (up to 8 weeks) ]
    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).

  11. Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2 [ Time Frame: 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.

  12. Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4 [ Time Frame: 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.

  13. Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8 [ Time Frame: 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.

  14. Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment [ Time Frame: End of treatment (up to 8 weeks) ]
    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.

  15. Withdrawal [ Time Frame: Week 4 and 8 ]

    How many subjects withdrew from the study. Reasons for withdrawal:

    due to exclusion criteria emerging, due to AE(s), or due to other reason




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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120223


Locations
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Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Alexander V Anstey, MD Royal Gwent Hospital
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01120223    
Other Study ID Numbers: MBL 0412 INT
2008-005456-24 ( EudraCT Number )
First Posted: May 10, 2010    Key Record Dates
Results First Posted: December 1, 2014
Last Update Posted: April 14, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases