CLINICAL TRIALS PROFILE FOR TRANSDERM SCOP
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All Clinical Trials for TRANSDERM SCOP
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00716014 ↗ | Study of TD101, a Small Interfering RNA (siRNA) Designed for Treatment of Pachyonychia Congenita | Completed | Pachyonychia Congenita Project | Phase 1 | 2008-01-01 | Pachyonychia congenita (PC) is a rare, autosomal dominant keratin disorder affecting the nails, skin, oral mucosae, larynx, hair and teeth. Pathogenic mutations in keratin K6a, K6b, K16 or K17 act via a dominant negative mechanism, leading to manifestations of the disease. The most disabling PC symptom is a painful plantar blistering and keratoderma that requires use of ambulation devices in more than 50 percent of patients. Despite our understanding of the molecular basis of PC, current treatment is limited to mechanical removal of the thick calluses, non-specific topical keratolytics, and oral retinoids, none of which alleviates blistering or plantar pain satisfactorily. A public charity, PC Project, has been founded to support the development of treatments for PC (www.pachyonychia.org). In collaboration with this charity, a small company, TransDerm, Inc., has developed a small interfering RNA (siRNA) that specifically targets a mutation in one of the PC keratins, K6a. As this siRNA targets a single nucleotide mutation, it will only be effective against PC subjects harboring this specific mutation. There are currently only six known patients who carry this mutation in the International Pachyonychia Congenita Research Registry, but three of these patients live in Salt Lake City (a mother and two of her children). We propose to perform a Phase Ib clinical trial to test the safety and tolerability of TD101 in PC patients carrying an N171K mutation. We will complete treatment of the adult patient prior to recruitment of the minors. |
| NCT03029650 ↗ | Scopolamine Patch Pharmacokinetics in Healthy Adults | Completed | University of Minnesota | Phase 4 | 2016-11-01 | The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Transderm Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of individuals utilizing these types of products. |
| NCT03029650 ↗ | Scopolamine Patch Pharmacokinetics in Healthy Adults | Completed | University of Minnesota - Clinical and Translational Science Institute | Phase 4 | 2016-11-01 | The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Transderm Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of individuals utilizing these types of products. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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