Phase 2
N=44
Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE)
Pseudoxanthoma Elasticum
Bottom Line
View on ClinicalTrials.gov: NCT01525875 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Von Kossa Staining Per Unit Area of Dermis — -0.0033; 0.0010; 0.0087; 0.0123 microns
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Magnesium Oxide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mark Lebwohl
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Von Kossa Staining Per Unit Area of Dermis |
-0.0033; 0.0010; 0.0087; 0.0123; 0.0054; 0.0132 | — |
| SECONDARY Number of Participants With a 1-point Decrease of Target Lesions |
2; 1; 8; 6; 9; 7 | — |
| SECONDARY LogMar |
-0.049; -0.063; 0.027; 0.015; -0.022; -0.047 | — |
| SECONDARY VAS - Visual Acuity Score |
-1.124; -0.602; 0.795; -0.729; -0.329; -1.332 | — |
| SECONDARY Central Retinal Thickness |
2.965; -3.552; -4.203; -6.796; -1.238; -10.348 | — |
Summary
The purpose of this study is to evaluate the effectiveness of magnesium oxide supplements on the reversal of calcium deposits in the skin, and the yellow bumps and folds of skin in subjects with pseudoxanthoma elasticum (PXE). Magnesium oxide is a dietary supplement that has been shown in some research to reduce these calcium deposits. This study consists of two parts. The first part is a year-long, double-blind, placebo-controlled study. Part two is an open-label, year-long study. In Part 1, qualified subjects will be randomized to receive either magnesium oxide supplements or placebo, in a 1:1 ratio for the first 12 months. The starting dose will be 1000 mg daily, and depending on tolerability, doses may be decreased. Baseline evaluations will be comprised of: blood tests; clinical evaluations; skin biopsy; eye examination; bone density test; and photography of skin lesions. Subjects will be evaluated at week 2, week 6, month 3, and then every 3 months during the first year. Upon completion of the first year, barring any safety concerns, all subjects will be administered magnesium oxide supplements for up to one additional year. Subjects will undergo the same evaluations/ procedures every 3 months. We hypothesize that the magnesium oxide will cause a reduction in calcifications in the subject's soft tissue/skin. Funding Source - FDA OOPD.
Eligibility Criteria
Inclusion Criteria
- Male or female subject at least 18 years of age
- If female, the subject is not pregnant or nursing
- If female of child bearing potential, the subject has a negative urine pregnancy test at the first visit, and agrees to use an approved method of contraception (hormonal contraceptives [birth control pills, implants [Norplant] or injections [DepoProvera]); intrauterine device (IUD); two forms of barrier methods [condoms and diaphragm]; or abstinence (no sexual activity) throughout the entire study
- Biopsy confirmed diagnosis of pseudoxanthoma elasticum (documenting some calcification of elastic fibers)
- Subject has a clinical disease severity grade of at least "1" (Poorly defined, barely visible macules) at screening.
- Normal kidney function tests
Exclusion Criteria
- Any subject who is pregnant or becomes pregnant during the study
- Subjects with a serum creatinine greater than 1.6 mg/dL
- Subjects with hypermagnesemia, hypokalemia, or idiopathic hypercalciuria
- Subjects with kidney disease or renal tubular defects (eg. Fanconi's syndrome), or on dialysis
- Subjects with hypothyroidism or hypoparathyroidism or primary hyperparathyroidism
- Subjects with acute gout
- Subjects with malabsorption, or osteomalacia
- Subjects on diuretics, magnesium containing antacids, or anabolic steroids
- Subjects with Cushing's syndrome
- Subjects receiving lithium and those with significant psychiatric disorders that would likely interfere with participation in this study
- Subjects taking anti-seizures medications and anti-arrhythmics medications
- Subjects on tetracycline or metronidazole and ace inhibitors
- Subjects taking cyclosporine or calcineurin inhibitors
Data sourced from ClinicalTrials.gov (NCT01525875). 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.