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

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Scalp Psoriasis

Treatments: Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01120223

MBL 0412 INT

2008-005456-24 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

LEO 80185 gel once daily application

Experimental group

Treatment:

Drug: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)