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Placebo-controlled, Case-controlled, Open Label Therapeutic Trial for Unilateral or Bilateral Lymphedema of Arm or Leg.
This study compares the effectiveness of a study drug versus placebo in the treatment of lymphedema.
Details
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 117 |
| Start date | 2009-03 |
| Completion | 2017-03 |
Conditions
- Lymphedema
Interventions
- Ketoprofen
- Placebo
Primary outcomes
- Part 1: Count of Participants Able to Complete Ketoprofen Treatment — Baseline to month 6
Participants who were able to complete ketoprofen treatment and experienced no treatment-related serious adverse events. - Part 2: Change From Baseline in Cutaneous Histological Architecture — Baseline; Month 4
Quantitative assessment of paired histological specimens of lymphedema skin pre- and post-treatment with ketoprofen. The impact of treatment on cutaneous histopathology was evaluated through the use of an empirically-derived scoring system (comprised of dermal thickness, intercellular mucin content, deep dermal collagen content, and perivascular infiltrate); this quantitative assessment was developed and performed by a dermatopathologist. Each characteristic was weighted equally and each specimen was assigned a cumulative subscale score of 0-5. The scores were summed for a total score (range: 0-20) which is presented here. Higher scores indicate a higher degree of pathology. A quantitatively higher negative change indicates a more favorable therapeutic response in the histology. - Part 3: Measurement of Skin Thickness — Baseline and 4 months
Caliper-measured skin thickness (mm) was serially assessed and pre-to-post paired analysis was performed for both arms (Placebo and Ketoprofen) of the study.
Countries
United States