Comparison of 122-0551 Foam Versus Vehicle for Plaque Psoriasis
Product: 122-0551 foam
Sponsor: Therapeutics, Inc
Stage of development: Phase 3
ClinicalTrials.gov Identifier: NCT02368210
Study start: January 2015
Study completion: October 2015 (August 2015 final collection date for primary outcome measure)
This phase 3 study will compare the efficacy and safety of 122-0551 foam (a glucocorticoid receptor agonist) and vehicle foam applied twice daily for 2 weeks in participants (aged ≥18 years) with plaque psoriasis.
The primary outcome measure will include the proportion of participants rated a “treatment success” based on the investigator global assessment.
Secondary outcome measures will include the proportion of participants rated a “treatment success” for each of the clinical signs of psoriasis: scaling, erythema, and plaque elevation.
HPA Axis Suppression Following Treatment With Desoximetasone Topical Spray 0.25% in Pediatric Patients With Plaque Psoriasis
Product: Topicort® (desoximetasone) topical spray 0.25%
Sponsor: Taro Pharmaceuticals USA
Stage of development: Phase 4
ClinicalTrials.gov Identifier: NCT02340169
Study start: December 2014
Study completion: April 2016
This open-label, postmarketing safety study will evaluate the potential of Topicort (desoximetasone) topical spray 0.25% to suppress hypothalamic-pituitary-adrenal (HPA) axis function following twice daily dosing for 28 days in pediatric patients aged 2 to 17 years with moderate to severe plaque psoriasis. Participants will be serially enrolled into 3 cohorts.
The primary outcome measure will include HPA axis function suppression as measured by cortisol response test.
Secondary outcome measures will include evaluation of efficacy parameters, pharmacokinetics, and adverse events.
Long-term Safety and Efficacy of Calcitriol 3 µg/g Ointment in Pediatric Participants With Plaque Psoriasis
Product: Calcitriol 3 µg/g ointment
Sponsor: Galderma
Stage of development: Phase 4
ClinicalTrials.gov Identifier: NCT02125279
Study start: May 2014
Study completion: October 2016
This multicenter study will evaluate the safety and efficacy of calcitriol 3 µg/g ointment applied twice daily (without occlusion) to treat pediatric participants aged 2 to 17 years with mild to moderate plaque psoriasis for up to 26 weeks.
The primary outcome measure will include laboratory parameters related to calcium metabolism after 26 weeks of topical treatment with calcitriol 3 µg/g.
Evaluation of Calcipotriene Foam 0.005% Versus Vehicle Foam in Pediatric Patients With Plaque Psoriasis
Product: STF 115469 foam (calcipotriene foam 0.005%)
Sponsor: GlaxoSmithKline
Stage of development: Phase 3
ClinicalTrials.gov Identifier: NCT01582932
Study start: April 2013
Study completion: April 2019
This multicenter study will compare calcipotriene foam 0.005% with vehicle foam in pediatric participants aged 2 to 11 years (inclusive) with mild to moderate plaque psoriasis. Study participants or a primary caregiver will apply calcipotriene foam 0.005% as a thin layer twice daily (morning and evening) on the body and scalp (excluding the face) for up to 8 weeks.
The primary outcome measure will include treatment success.
Secondary outcome measures will include erythema, scaling, and plaque thickness.