PSORIASIS
A Multicenter Open Label Uncontrolled Study of the Long Term Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 26 Weeks in Pediatric Subjects (2 to 17 Years of Age) With Mild to Moderate Plaque Psoriasis
Sponsored by Galderma, the objective of this study is to evaluate
the safety and efficacy of up to 26 weeks of treatment with
calcitriol 3 mcg/g ointment when used twice daily, without occlusion,
to treat pediatric subjects (2 to 17 years of age) with
mild to moderate plaque psoriasis.
The inclusion criteria for this study are male or female 2 to 17
years of age with a clinical diagnosis of stable mild to moderate
plaque psoriasis.
The exclusion criteria are other forms of psoriasis hypercalcemia,
past history of kidney stones, Vitamin D deficiency, or
other concomitant dermatological disease.
Primary outcome measures are laboratory parameters related
to calcium metabolism after 26 weeks of topical treatment with
Calcitriol 3 mcg/g (Time Frame: week 26) and proportion of
subjects with serum albumin-adjusted calcium higher than the
upper normal limit and/or Parathyroid hormone (PTH) levels
below the lower limit of normal, and incidence of urolithiasis.
Phase II Randomized Double Blinded Placebo Controlled, Multiple-dose Regimen Study to Assess the Rate of Histological Clearance and Effect on Molecular Pathways as Well as on Biomarkers of 12 Months Secukinumab 300 mg s.c. Treated Patients With Chronic Plaque-type Psoriasis
Sponsored by Novartis, This study is designed to evaluate
the proportion of patients achieving reversal of chronic
plaque psoriasis at week 4 and 12 following multiple doses of
secukinumab administered subcutaneously (sc) compared to
placebo. Starting from week 13, all patients will receive multiple
doses of secukinumab up to week 52 to study long term
effects of secukinumab. Clinical endpoints including biomarker
assessments, PASI, IGA, and DLQI will be compared to better
understand, why secukinumab may be effective in psoriasis patients.
The primary outcome measure is for patients to achieve
skin histology response after secukinumab treatment after 12
weeks of treatment.
Patients being tested have chronic plaque-type psoriasis diagnosed
for at least 6 months, moderate to severe psoriasis
as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body
surface area) affected by plaque-type psoriasis of ≥10%, and
chronic plaque-type psoriasis considered inadequately controlled
by: topical treatment and/or; phototherapy and/or
previous systemic therapy.
MOLLUSCOM CONTAGIOSUM
A Dose Range-Finding Phase 2 Trial of a Botanical Drug for the Treatment of Molluscum Contagiosum in Pediatric Subjects
Sponsored by ViroXis Corporation, this trial will be a multi-center,
double-blind, randomized, placebo-controlled safety and
efficacy trial to evaluate the efficacy and safety of VIR003 treatment
regimen when administered to pediatric subjects with
molluscum contagiosum. Once subject eligibility is confirmed
the subject will start the Treatment Period of the study. All subjects
will receive one of three active treatments or placebo with
the first dose applied at the day 0 study visit. Subjects will be
instructed on how to apply the study medication twice a day for
60 days of treatment. Subjects will return to the clinic on study
days, 7, 14, 30, 45, and 60 for routine evaluations and then on
study day 90 for the final study visit.
