11 completed. 4 Phase 3, 3 Phase 1, 3 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Completed 4 |
| Phase 1 | 3 | Completed 3 |
| Phase 2 | 3 | Completed 3 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies spinosad topical suspension, 0.9%, Placebo - Scabies | Phase 3 | Completed | ParaPRO LLC | 280 | 2017-05-10 | 2021-05-21 |
| Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies spinosad topical suspension, 0.9%, Placebo - Scabies | Phase 3 | Completed | ParaPRO LLC | 291 | 2017-05-02 | 2021-05-19 |
| Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation spinosad - Pediculosis | Phase 4 | Completed | ParaPRO LLC | 26 | 2011-09-01 | 2012-11-22 |
| NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers NatrOVA Creme Rinse - 1%, NatrOVA Creme Rinse Vehicle Only, Blank Patch - Head Lice | Phase 1 | Completed | ParaPRO LLC | 65 | 2008-01-01 | 2008-08-04 |
| Phototoxicity Potential of NatrOVA Creme Rinse - 1% Spinosad (the active ingredient in NatrOVA), placebo - Head Lice | Phase 1 | Completed | ParaPRO LLC | 37 | 2007-12-01 | 2008-05-20 |
| Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice Spinosad, Permethrin 1% - Pediculosis | Phase 3 | Completed | ParaPRO LLC | 558 | 2007-09-01 | 2012-10-11 |
| Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice Spinosad, Permethrin 1% - Pediculus Capitis Infestation | Phase 3 | Completed | ParaPRO LLC | 480 | 2007-09-01 | 2012-10-11 |
| A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse NatrOVA Creme Rinse - 1%, NIX Creme Rinse - 1% permethrin - Pediculosis Capitis, Head Lice | Phase 2 | Completed | ParaPRO LLC | 24 | 2007-03-01 | 2009-03-09 |
| A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age NatrOVA Creme Rinse (1%) - Pediculosis Capitis (Head Lice) | Phase 1 | Completed | ParaPRO LLC | 6 | 2006-12-01 | 2008-08-01 |
| A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis Spinosad Creme Rinse - Pediculosis Capitis (Head Lice) | Phase 2 | Completed | ParaPRO LLC | 120 | 2006-03-01 | 2006-07-12 |
| A Pilot Dose Ranging Study of Spinosad Creme Rinse Spinosad Creme Rinse - Vehicle Control, Spinosad Creme Rinse - Pediculosis Capitis, Head Lice | Phase 2 | Completed | ParaPRO LLC | 36 | 2005-09-01 | 2015-10-20 |
Lice Infestations (2) · Scabies (2)
spinosad (6) · Suspensions (5) · Permethrin (1)
United States (11)
Bill Miller, MD (2) · Kerry W Mettert, MBA (2) · Dowling B Stough, M.D. (1) · Dyal Garg, Ph.D. (1) · Dyal Garg, PhD (1) · Jeffrey C Seiler, M.D. (1) · John V Murray, MD (1) · John V. Murray, MD (1) · Mark Moore, MD (1) · Michael Brown, MD (1) · Michael Noss, MD (1) · Robert Lewine, MD (1)