NCT01676792

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2011

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 22, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

August 29, 2012

Last Update Submit

April 21, 2014

Conditions

Vulvar Intraepithelial NeoplasiaGenital Warts

Keywords

condyloma acuminateano-genital wartsgenital wartscutaneous condylomaVulva pre-cancerous lesionsVulvar Intraepitheral NeoplasiaVINEGW

Outcome Measures

Primary Outcomes (1)

  • Patients achieve greater than or equal to 75% lesion size reduction

    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

    20 weeks (16 weeks treatment period + 4 weeks follow-up period)

Secondary Outcomes (2)

  • Total clearance rate

    20 weeks (16 weeks treatment period + 4 weeks follow-up period)

  • Partial clearance rate

    20 weeks (16weeks treatment period + 4 weeks follow-up period

Other Outcomes (1)

  • Safety

    16 weeks

Study Arms (1)

Lesion reduction

EXPERIMENTAL
Drug: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract

Interventions

SR-T100 gel with 2.3% of SM in Solanum undatum plant extractDRUG

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.

Also known as: SR-T100 gel
Lesion reduction

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 744, Taiwan

Location

MeSH Terms

Conditions

Condylomata Acuminata

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Keng-Fu Hsu, MD, PhD.

    National Cheng-Kung University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

April 1, 2011

Primary Completion

April 1, 2013

Study Completion

October 1, 2013

Last Updated

April 22, 2014

Record last verified: 2014-04

Locations

TW(1)