Efficacy and Safety of SR-T100 Gel in Common Warts (CW) Patients (NCT01796795) | Clinical Trial Compass
SuspendedPhase 2
Efficacy and Safety of SR-T100 Gel in Common Warts (CW) Patients
Stopped: Budget issue.
102 participantsStarted 2030-09
Plain-language summary
This phase II study is to evaluate the efficacy of SR-T100 gel in complete clearance of target warts at different concentrations (1.0% and 2.3% of SM in Solanum undatum plant extract) in patients with CW.
Who can participate
Age range17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 17 years old.
✓. The diagnosis of CW is based on visual inspection by an experienced dermatologist.
✓. Patient is selected ≤ 5 CW lesions; each of the target lesion(s) needs to be ≤ 15 mm in diameter. For patient with only 1 selected lesion, the size of target lesion needs to be measuring 2 to 15 mm in diameter.
✓. Patient agrees to apply the study medication on target CW lesion(s) with an occlusive dressing for at least 20 hours per day.
✓. Patient or the legally acceptable representative of patient under 20 years of age, is willing and able to provide written informed consent.
✓. Patient agrees not to use wart-removing product/modality (prescription or over-the-counter) other than the study product during the course of the study; and is willing to refrain from using cosmetics or other topical products in the treatment area for the duration of the study.
✓. Any non-target CW receiving wart-removing procedures including cryotherapy and surgical therapy should be at least 5 cm apart from the target lesions.
✓. Patient is free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk to the patient.
Exclusion criteria
✕. The treatment area is located in any of the following areas: the eye area (including eyelids), lips, mouth cavity, nasal cavity,inner ear, soles of the feet, underneath the nails, and the anogenital area.
. Patient had participated in a clinical study within 30 days prior to the Randomization visit, or is currently participating in another clinical study.
✕. Patient had used any wart-removing product/modality in the treatment area within 30 days prior to the Randomization visit or received cryotherapy in the treatment area within 60 days prior to the Randomization visit.
✕. Patient who has immune-compromised conditions, have required or will require systemic intake of immunosuppressive or immunomodulatory medication (oral or parental corticosteroids are included) within 30 days prior to the Randomization visit or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed.
✕. Patient has clinically significant or unstable medical conditions (psychologically and physically) in any of the following listed situations:
✕. Clinically significant peripheral vascular disease based on medical history.
✕. Current uncontrolled infection, current skin infections and/or skin disorder in the treatment area other than CW and/or in the area surrounding the warts that may confound or affect study assessment procedure of the study endpoints.
✕. Chronic or acute medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk (including human immunodeficiency virus, systemic lupus erythematosis, active viral hepatitis, etc.).