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NCT01433731 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
A Phase 1 study, sponsored by TetraLogic Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01433731: Completed Phase 1 study, sponsored by TetraLogic Pharmaceuticals.
NCT01433731 is a Phase 1 study that has completed, run by TetraLogic Pharmaceuticals. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01433731, a Phase 1 study, has completed, sponsored by TetraLogic Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.
Primary Outcome
Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo- or hyperpigmentation, each on a scale of 0-8; and lesion size (cm2), on a scale of 0 (no lesion; 0 cm2) to 18 (300 cm2). Up to five index lesions are each scored, and a subtotal CAILS score is provided for each index lesion. A total score is calculated by summing these subtotals. Response cri
Interventions
- DRUG placebo for SHAPE (SHP-141)
- DRUG SHAPE (SHP-141) 0.1% BID
- DRUG SHAPE (SHP-141) 0.5% BID
- DRUG SHAPE (SHP-141) 1.0% BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01433731 record still lists
NCT01433731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which placebo for SHAPE (SHP-141) is the first listed.
NCT01433731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01433731 about?
NCT01433731 is a clinical study titled "Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)". The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL...
What is the current status of trial NCT01433731?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-11. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01433731?
The interventions under investigation include: placebo for SHAPE (SHP-141) (DRUG), SHAPE (SHP-141) 0.1% BID (DRUG), SHAPE (SHP-141) 0.5% BID (DRUG), SHAPE (SHP-141) 1.0% BID (DRUG).
Who is sponsoring clinical trial NCT01433731?
This trial is sponsored by TetraLogic Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01433731's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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