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

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ClinicalTrials.gov Identifier: NCT01676792
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : April 22, 2014
Sponsor:
Collaborator:
G&E Herbal Biotechnology Co., LTD
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Vulvar Intraepithelial Neoplasia Genital Warts Drug: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : April 2011
Primary Completion Date : April 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Patients achieve greater than or equal to 75% lesion size reduction [ Time Frame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period) ]
    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 :
  1. Total clearance rate [ Time Frame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period) ]
    Proportions of patient with treated VIN(s) or EGW(s) completely eradicate.

  2. Partial clearance rate [ Time Frame: 20 weeks (16weeks treatment period + 4 weeks follow-up period ]
    Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline.


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



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676792


Locations
Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 744
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

Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01676792     History of Changes
Other Study ID Numbers: 100CT221
100CT221 ( Other Identifier: National Research Program for Biopharmaceuticals, NRPB )
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: April 22, 2014
Last Verified: April 2014

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