Your session is about to expire
Summary
This trial tests a topical cream with pirenzepine for HIV patients who have nerve pain. The cream aims to reduce pain by blocking pain signals. The study will check if the cream is safe and effective over a few months.
Eligible Conditions
- HIV-associated Neuropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment Emergent Adverse Events as assessed by ECG (measuring p wave, QRS complex, QT interval)
Incidence of Treatment Emergent Adverse Events as assessed by dermal assessment (Draize score 0.0-4.0) score of skin erythema, edema pruritus and dryness score) of the dosing area
Incidence of Treatment Emergent Adverse Events as assessed by hematology and clinical pathology blood tests
+1 moreSecondary study objectives
IENFD change from baseline for both treated and untreated skin
Medical Outcomes Study HIV Health Survey (MOS-HIV)
Neuropathic Pain Scale-10 (NPS-10)
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: WST-057Experimental Treatment1 Intervention
WST-057 topical solution
Group II: PlaceboPlacebo Group2 Interventions
WST-057 Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WST-057
2022
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
WinSanTor, IncLead Sponsor
3 Previous Clinical Trials
176 Total Patients Enrolled
Angela HansenStudy DirectorWinSanTor, Inc
3 Previous Clinical Trials
176 Total Patients Enrolled
Share this study with friends
Copy Link
Messenger