A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Dose-ranging Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Common Warts (CW) Patients.
1. Age ≥ 6 years old.
2. The diagnosis of CW is based on visual inspection by an experienced dermatologist.
3. Patient with ≤ 5 CW lesions; for patient with only 1 lesion, the size needs to be
measuring 2 to 15 mm in diameter; each of the target lesion(s) to be treated needs to
be ≤ 15 mm in diameter.
4. Patient agrees to apply the study medication on target CW lesion(s) with an
occlusive dressing for at least 20 hours per day.
5. Patient or the legally acceptable representative of patient under 20 years of age, is
willing and able to provide written informed consent.
6. 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.
7. Any non-target CW receiving wart-removing procedures including cryotherapy and
surgical therapy should be at least 5 cm apart from the target lesions.
8. 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
9. Patient is judged to be in good health based upon the results of physical
examinations (PEs), medical history, and safety laboratory tests.
10. Patient in good general health condition (performance status ≤ 2 Eastern Cooperative
Oncology Group (ECOG)).
11. Patient agrees to be photographed of the CW target lesion(s) and used of such data as
part of the study package.
12. Female patient of childbearing potential should have a negative urine or serum
pregnancy test at Screening day, and is willing to use effective contraception during
1. 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.
2. Patient had participated in a clinical study within 30 days prior to the
Randomization visit, or is currently participating in another clinical study.
3. 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.
4. 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.
5. Patient has clinically significant or unstable medical conditions (psychologically
and physically) in any of the following listed situations:
1. Clinically significant peripheral vascular disease based on medical history.
2. 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.
3. 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
6. Patient is pregnant, plan to become pregnant, or is breastfeeding.
7. Patient has a history of allergy or sensitivity to Solanum undatum plant extract, SM,
or SR-T100 gel excipients including carbomer, propylene glycol, and triethanolamine.