Phase 2
Completed N=78
Safety and Efficacy of LEO 80185 Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
Source: ClinicalTrials.gov NCT01120223 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Percentage of Subjects With Adverse Drug Reactions (ADRs) — 6.4 percent subjects
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Adverse Drug Reactions (ADRs) |
6.4 | — |
| PRIMARY Change in Albumincorrected Serum Calcium From Baseline to Week 4 |
-0.014 | — |
| PRIMARY Change in Albumincorrected Serum Calcium From Baseline to Week 8 |
-0.002 | — |
| PRIMARY Change in Albumincorrected Serum Calcium From Baseline to End of Treatment |
0.000 | — |
| PRIMARY Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4 |
-0.01 | — |
| PRIMARY Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8 |
0.03 | — |
| PRIMARY Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment |
-0.03 | — |
| PRIMARY Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4 |
-0.269 | — |
| PRIMARY Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8 |
-0.003 | — |
| PRIMARY Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment |
-0.1156 | — |
| SECONDARY Change in Plasma PTH From Baseline to Week 4 |
1.2 | — |
| SECONDARY Change in Plasma PTH From Baseline to Week 8 |
-2.8 | — |
| 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 |
37 | — |
| 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 |
59 | — |
| 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 |
49 | — |
| 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 |
66 | — |
| 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 |
-62.7 | — |
| 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 |
-72.1 | — |
| 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 |
-76.6 | — |
| 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. |
-80.4 | — |
| SECONDARY Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2 |
44 | — |
| SECONDARY Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4 |
55 | — |
| SECONDARY Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8 |
51 | — |
| 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 |
68 | — |
| SECONDARY Withdrawal |
4 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01120223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.