SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma

This study is currently recruiting participants.
Verified September 2012 by National Cheng-Kung University Hospital
Sponsor:
Collaborator:
G&E Herbal Biotechnology Co., LTD
Information provided by (Responsible Party):
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01676792
First received: August 29, 2012
Last updated: September 3, 2012
Last verified: September 2012
  Purpose

This pilot clinical study is to evaluate the efficacy & safety of SR-T100 gel (2.3% of SM in Solanum undatum plant extract) in patients with VIN(s) or EGW(s).


Condition Intervention Phase
Vulvar Intraepithelial Neoplasia
Genital Warts
Drug: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Efficacy & Safety of Topical SR-T100 Gel in the Treatment of Human Vulva Pre-cancerous Lesions (Vulvar Intraepithelial Neoplasia; VIN) & Cutaneous Condyloma(External Genital Warts; EGWs)

Resource links provided by NLM:


Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • Patients achieve greater than or equal to 75% lesion size reduction [ Time Frame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period) ] [ Designated as safety issue: No ]
    Proportion of patients achieving greater than or equivalent to 75% lesion size reduction from baseline on the 20th week after 16 weeks of SR-T100 gel treatment


Secondary Outcome Measures:
  • Total clearance rate [ Time Frame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period) ] [ Designated as safety issue: No ]
    Proportions of patient with treated VIN(s) or EGW(s) completely eradicate.

  • Partial clearance rate [ Time Frame: 20 weeks (16weeks treatment period + 4 weeks follow-up period ] [ Designated as safety issue: No ]
    Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline.


Other Outcome Measures:
  • Safety [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    To evaluate safety profile of SR-T100 gel by adverse events, serious adverse events, PEs, vital signs & laboratory data changes.


Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lesion reduction Drug: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract
Self administered topical SR-T100 gel on lesion(s) including its peripheral normal skin approximately 1cm around the lesion with the amount of 0.02 g/cm squared with occlusive dressing once daily. Patients who is unable to tolerate with occlusive dressing is instructed 3 times daily in the morning, afternoon & before bed time. Medication should be reapply after bathing or cleaning.
Other Name: SR-T100 gel

Detailed Description:

An open-label, pilot study to evaluate the efficacy & safety profiles of SR-T100 gel in treating patients with VINs or EGWs. Male & female older than 20 years old have at least one VIN or EGW with lesion size greater than 5 mm in diameter are candidates for this study. The primary endpoint is evaluated based on patients who has received 16-week treatment and presents evaluable measurement datas by the end of 20th week. The secondary endpoints will be evaluated based on all patients with measurable values for VINs or EGWs, recruited patients in this study has never had experiencs associated with prior SR-T100 treatment of any sorts during their life time before becoming a participant in this study. The study plans to recruit 20 patients with VINs or EGWs, the enrollment duration will last two years with total of 40 patients involved.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

(EGW group)Inclusion Criteria:

  • Male & female patients older than 20 years old presents at least one pathologically confirmed with histopathology EGW with lesion size greater than 5mm in diameter.

(EGW group)Exclusion Criteria:

  • Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell carcinoma, having treated with other investigational drugs within 30 days, pregnancy & lactating females, female with pregnancy potential without using effective boundary barrier or patients with immune-deficience.

(VIN group)Inclusion Criteria:

  • Female patients older than 20 years old presents at least one histopathologically confirmed VIN with lesion size greater than 5mm in diameter.

(VIN group)Exclusion Criteria:

  • Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell carcinoma, having treated with other investigational drugs within 30 days, pregnancy & lactating females, female with pregnancy potential without using effective boundary barrier or patients with immune-deficience.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676792

Contacts
Contact: Keng-Fu Hsu, MD, PhD +886-6-2353535 ext 5222 d5580@mail.ncku.edu.tw

Locations
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 744
Contact: Keng-Fu Hsu, MD, PhD.    +886-6-2353535 ext 5222    d5580@mail.ncku.edu.tw   
Principal Investigator: Keng-Fu Hsu, MD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
G&E Herbal Biotechnology Co., LTD
Investigators
Principal Investigator: Keng-Fu Hsu, MD, PhD. National Cheng-Kung University Hospital
  More Information

No publications provided

Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01676792     History of Changes
Other Study ID Numbers: 100CT221, 100CT221
Study First Received: August 29, 2012
Last Updated: September 3, 2012
Health Authority: Taiwan : Food and Drug Administration
Taiwan: National Health Research Institutes

Keywords provided by National Cheng-Kung University Hospital:
condyloma acuminate
ano-genital warts
genital warts
cutaneous condyloma
Vulva pre-cancerous lesions
Vulvar Intraepitheral Neoplasia
VIN
EGW

Additional relevant MeSH terms:
Warts
Neoplasms
Condylomata Acuminata
Carcinoma in Situ
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 16, 2014