Safety and Efficacy of Calcipotriol plus Betamethasone Dipropionate Gel in Adolescent Patients (Aged 12 to 17 Years) with Scalp Psoriasis
- Conditions
- Psoriasis of the scalp.MedDRA version: 12.1Level: LLTClassification code 10037153Term: Psoriasis
- Registration Number
- EUCTR2008-005456-24-FR
- Lead Sponsor
- EO Pharmaceuticals Products Ltd. A/S (LEO Pharma A/S)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 78
1. Signed informed consent given by parent(s), or legal guardian(s), or by the subject (according to national law) following their receipt of verbal and written
information about the study.
2. Subjects will receive verbal and written information and will provide written assent to the study if applicable.
3. Subjects 12 to 17 years of age.
4. Either sex.
5. Any race or ethnicity.
6. Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
7. At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
- amenable to topical treatment with a maximum of 60 g of study medication per week, and
- of an extent of more than or equal to 10% of the scalp area
- of at least moderate severity according to the investigator’s global assessment.
8. Attending a hospital out-patient clinic or the private practice of a dermatologist.
9. Serum albumin-corrected calcium below the upper reference limit at SV2.
10. Females of child-bearing potential must have a negative urine pregnancy test result and must agree to use a highly effective method of contraception during the study according to national requirements and/or the judgement of the investigator (abstinence is an acceptable method). The contraception should have started an adequate period of time before the pregnancy test, as judged by the (sub)investigator, bearing in mind that the urine pregnancy test may not detect a pregnancy until the first missed period.
11. Subjects fulfilling national requirements/law for participation in this study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. A history of hypersensitivity to any component of the LEO 80185 gel.
2. 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.
3. Topical treatment on the face and/or genital/skin folds with potent or very potent (WHO groups IIIIV) corticosteroids within 2 weeks prior to Visit 1 or during the study.
4. 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 halflives (whichever is longer) prior to Visit 1
5. 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.
6. UVB therapy within 2 weeks prior to Visit 1 or during the study.
7. 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.
8. Systemic calcium or vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 or during the study.
9. Planned initiation of, or changes to, concomitant medication that could affect scalp psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the study.
10. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
11. 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.
12. Other inflammatory skin diseases that may confound the evaluation of scalp psoriasis.
13. Planned excessive exposure to sun during the study that may affect scalp psoriasis.
14. Known or suspected severe renal insufficiency or severe hepatic disorders.
15. Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
16. Any clinically significant abnormality following review of screening laboratory tests (blood and urine samples), physical examination or blood pressure/heart rate measurement performed at SV2.
17. Current participation in any other interventional clinical trial.
18. Previously enrolled in this trial.
19. Subjects who have received any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within a month prior to SV1 or longer, if the class of substance required a longer wash-out as defined above (e.g., biological treatments).
20. Subjects or parent(s) or legally acceptable guardian(s) known or suspected of not being able to comply with the trial protocol (e.g., alcoholism, drug dependency or psychotic state).
21. Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the study, or who are breast-feeding.
22. Females of child-bearing potential with a positive pregnancy test at SV2.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method