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Efficacy and Safety of SR-T100 Gel in Common Warts (CW) Patients

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified February 2016 by G&E Herbal Biotechnology Co., LTD
Sponsor:
Information provided by (Responsible Party):
G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier:
NCT01796795
First received: February 18, 2013
Last updated: February 17, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Common Wart Drug: Vehicle gel Drug: SR-T100 gel with 1.0% of SM Drug: SR-T100 gel with 2.3% of SM Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by G&E Herbal Biotechnology Co., LTD:

Primary Outcome Measures:
  • Total clearance rate of treated CW [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Proportion of patient with at least 75% reduction in CW lesion counts [ Time Frame: 16 weeks ]
  • Proportion of patient with at least 50% reduction in lesion size (volume) [ Time Frame: 16 weeks ]
  • Mean of percent reduction in CW lesion counts from individual patient by visit [ Time Frame: 16 weeks ]
  • Mean of percent reduction in CW lesion size from individual patient by visit [ Time Frame: 16 weeks ]
  • CW recurrence rate [ Time Frame: 28 weeks ]
  • Time to complete clearance [ Time Frame: 16 weeks ]
  • Percent reduction for pooled lesion counts by visit [ Time Frame: 16 weeks ]
  • Safety: evaluate the changes occurring from baseline (Randomization visit) to EOT visit. [ Time Frame: 28 weeks ]
    including PE, vital sign, lab. test, local skin reaction, and adverse event, etc.


Estimated Enrollment: 102
Study Start Date: May 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: vehicle gel
The vehicle gel will be applied in appropriate amount evenly and gently in a thin-layer of gel by finger, not to exceed 0.2 g per administration (approximately 2 cm gel squeezed in length). Each dose of study drug is applied on the target lesion(s) and covered with an occlusive dressing for the entire day.
Drug: Vehicle gel
Topical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration.
Active Comparator: SR-T100 gel with 1.0% of SM
SR-T100 contains 1.0% SM. The gel will be applied in appropriate amount evenly and gently in a thin-layer of gel by finger, not to exceed 0.2 g per administration (approximately 2 cm gel squeezed in length). Each dose of study drug is applied on the target lesion(s) and covered with an occlusive dressing for the entire day.
Drug: SR-T100 gel with 1.0% of SM
Topical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration.
Active Comparator: SR-T100 gel with 2.3% of SM
SR-T100 contains 2.3%SM. The gel will be applied in appropriate amount evenly and gently in a thin-layer of gel by finger, not to exceed 0.2 g per administration (approximately 2 cm gel squeezed in length). Each dose of study drug is applied on the target lesion(s) and covered with an occlusive dressing for the entire day.
Drug: SR-T100 gel with 2.3% of SM
Topical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration.

  Eligibility

Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 17 years old.
  2. The diagnosis of CW is based on visual inspection by an experienced dermatologist.
  3. 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.
  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 patient.
  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 the study.

Exclusion Criteria:

  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 hepatitis, etc.).
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796795

Contacts
Contact: Kou-Wha Kuo, Ph.D +886-6-505-2976 ext 201 kwkuo@geherbs.com.tw

Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Not yet recruiting
Kaohsiung, Taiwan, 807
Contact: Chung-Hsing Chang, MD, PhD         
Principal Investigator: Chung-Hsing Chang, MD, PhD         
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. Not yet recruiting
Kaohsiung, Taiwan, 833
Contact: Wei-Ming Wu, MD, PhD         
Principal Investigator: Wei-Ming Wu, MD, PhD         
National Cheng Kung University Hospital Not yet recruiting
Tainan, Taiwan, 701
Contact: Chao-Chun Yang, MD    886-6-2353535      
Principal Investigator: Chao-Chun Yang, MD         
National Chi Mei Medical Center Not yet recruiting
Tainan, Taiwan, 710
Contact: Feng-Jie Lai, MD, PhD         
Principal Investigator: Feng-Jie Lai         
Sponsors and Collaborators
G&E Herbal Biotechnology Co., LTD
Investigators
Study Director: Kou-Wha Kuo, Ph.D G&E Herbal Biotechnology Co., LTD
Principal Investigator: Hamm-Ming Sheu, MD National Cheng-Kung University Hospital
  More Information

Responsible Party: G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier: NCT01796795     History of Changes
Other Study ID Numbers: GESRTCWA
Study First Received: February 18, 2013
Last Updated: February 17, 2016

Keywords provided by G&E Herbal Biotechnology Co., LTD:
common wart
verruca vulgaris

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on June 23, 2017