Phase 2
Completed N=33
Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
Source: ClinicalTrials.gov NCT00817219 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Adverse Drug Reactions — 2 participants
Summary
The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Drug Reactions |
2 | — |
| PRIMARY Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment |
— | — |
| PRIMARY Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment |
— | — |
| PRIMARY Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment |
0.005 | — |
| PRIMARY Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment. |
0.717 | — |
| SECONDARY "Controlled Disease"(i.e., "Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity at Week 4. |
20 | — |
| SECONDARY "Controlled Disease"(i.e., "Clear" or "Very Mild") According to the Patient's Global Assessment of Disease Severity at Week 4. |
23 | — |
| SECONDARY Percentage Change in PASI From Baseline to Week 4. |
-72.5 | — |
| SECONDARY PASI 75 at Week 4. |
17 | — |
| SECONDARY PASI 50 at Week 4. |
28 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 12 to 17 years, inclusive.
- Psoriasis vulgaris on the trunk and/or limbs which is:
- amenable to topical treatment
- of an extent of 5-30% of BSA
- of at least a moderate severity
- A serum cortisol concentration above 5 mcg/dL before ACTH-challenge and above 18 mcg/dL at 30 minutes after ACTH-challenge.
- Albumin-corrected serum calcium and urinary calcium: creatinine ratio within the reference range.
Exclusion Criteria
- Serious allergy, serious asthma, or serious allergic skin rash.
- A history of sensitivity to any medication.
- PUVA or Grenz ray therapy, UVB therapy, systemic treatment with biological therapies, corticosteroids, or other therapies with an effect on psoriasis, topical treatment with corticosteroids or vitamin D analogues, treatment with enzymatic inductors, cytochrome P450 inhibitors, hypoglycemic sulfonamides, antidepressive medications, estrogen therapy, calcium supplements or vitamin D supplements.
- Guttate, erythrodermic, exfoliative or pustular psoriasis.
- Viral lesions of the skin, fungal or bacterial skin infections, ulcers or wounds.
- Severe renal insufficiency, severe hepatic disorders, disorders of calcium metabolism associated with hypercalcemia, any cardiac condition or endocrine disorder.
- Diabetes mellitus
- Cushing's disease or Addison's disease.
Data sourced from ClinicalTrials.gov (NCT00817219). 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.