Clinical trial · Interventional
Clinical Study Assessment of SR-T100 Topical Gel Against Actinic Keratosis
An Open Phase II Study to Assess the Efficacy and Safety of Topical SR-T100® Gel in the Treatment of Human Cutaneous Squamous Cell Carcinoma in Situ (Actinic Keratosis and Bowen's Disease)
NCT02085395CI-TRIAL-00014027AKcompletedPhase 2ClinicalTrials.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)
To evaluate the efficacy of SR-T100 gel by observing the lesion size (length x width x height) of human cutaneous squamous cell carcinoma in situ (Actinic Keratosis and Bowen's Disease) reduced at least 75%.
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 |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
| Bowen's Disease | Squamous Cell Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SR-T100 ® Gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SR-T100 ® Gel
- description
- Topical gel containing 2.3% of solamargine in Solanum undatum extract is used once daily with occlusive dressing for 16 weeks.
- interventionNames
- Drug: SR-T100 ® Gel
Primary outcomes (1)
- measure
- Partial clearance rate
- timeFrame
- 16 weeks treatment and 4 weeks follow-up
- description
- To assess the response rate of SR-T100® gel in patients with cutaneous squamous cell carcinoma in situ (Actinic Keratosis: AK; and Bowen's Disease: BD), defined as the proportion of patients whose lesion size (length x width x height) reduced \> 75%.
Secondary outcomes (2)
- measure
- Complete clearance rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients met ALL of the inclusion criteria for the entry of this study: 1. Male or female; aged ≧ 20 years old. 2. Patients had histologically confirmed Squamous cell carcinoma in situ (AK or BD) for the targeted lesion. 3. Patients had a measurable lesion 5mm or larger for AK or 10mm or larger for BD. 4. Patient had a performance status of \< 2 (ECOG). 5. Patients who had signed an approved written informed consent. Exclusion Criteria: * Patients were excluded from this study for ANY of the following reasons: 1. Patients with histologic subtypes other than squamous cell carcinoma in situ (AK or BD). 2. Patients with tumor extending into the oral cavity, nostrils, eyelids, urethra, anus, vagina or rectum. 3. Patients who had grossly suspicious or inflamed nodes on physical examination. 4. Patients with grossly infected tumors. 5. Patients with recurrent invasive squamous cell carcinoma. 6. Patients with a history of other invasive malignancies, if there was any evidence of the other malignancy being present within the past 5 years. Patients were also excluded if their previous cancer treatment contraindicated this protocol therapy. 7. Use of any investigational drug in the 30 days before screening. 8. Pregnant or lactating women or women of childbearing potential using inadequate contraceptive methods.
References
Publications (0)
Data not yet available
No reference posted for this study.