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

NCT01676792 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2014-04-22

No results posted yet for this study

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).

Conditions

  • Vulvar Intraepithelial Neoplasia
  • Genital Warts

Interventions

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.

Sponsors & Collaborators

  • G&E Herbal Biotechnology Co., LTD

    collaborator INDUSTRY

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Keng-Fu Hsu, MD, PhD. · National Cheng-Kung University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-04-30
Completion
2013-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01676792 on ClinicalTrials.gov