Clinical trial · Interventional
SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma
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)
NCT01676792CI-TRIAL-00014315completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Warts | Condyloma Acuminatum | ALIAS | 0.90 |
| Vulvar Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SR-T100 gel with 2.3% of SM in Solanum undatum plant extract | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lesion reduction
- interventionNames
- Drug: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract
Primary outcomes (1)
- measure
- Patients achieve greater than or equal to 75% lesion size reduction
- timeFrame
- 20 weeks (16 weeks treatment period + 4 weeks follow-up period)
- description
- 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 outcomes (2)
- measure
- Total clearance rate
- timeFrame
- 20 weeks (16 weeks treatment period + 4 weeks follow-up period)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
(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.
References
Publications (0)
Data not yet available
No reference posted for this study.