Clinical Trials

A clinical trial evaluated the safety, efficacy, and pharmacokinetics of a topical spinosad formulation compared to placebo in patients diagnosed with scabies. Sponsored by ParaPRO LLC in collaboration with Concentrics Research, this completed Phase 3 study established the clinical utility and tolerability profile of spinosad as a specialized topical antiparasitic intervention.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02485717 Completed
Scabies
ParaPRO LLC|Concentrics Research
 2017-05-02 Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Spinosad product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Spinosad binds allosterically to nicotinic acetylcholine receptors in the ectoparasite nervous system, causing persistent neuronal activation and altered cholinergic neurotransmission. This unremitting synaptic excitation leads to involuntary muscle contractions, neuromuscular fatigue, and ultimate paralysis of the organism. Consequently, this target-specific neurotoxic mechanism accounts for the therapeutic efficacy of spinosad in eradicating human scabies mites, directly aligning with its evaluated clinical trial indications.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.