Clinical Study Assessment of SR-T100 Topical Gel Against Actinic Keratosis (NCT02085395) | Clinical Trial Compass
CompletedPhase 2
Clinical Study Assessment of SR-T100 Topical Gel Against Actinic Keratosis
Taiwan27 participantsStarted 2007-11
Plain-language summary
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%.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Male or female; aged ≧ 20 years old.
✓. Patients had histologically confirmed Squamous cell carcinoma in situ (AK or BD) for the targeted lesion.
✓. Patients had a measurable lesion 5mm or larger for AK or 10mm or larger for BD.
✓. Patient had a performance status of \< 2 (ECOG).
✓. Patients who had signed an approved written informed consent.
Exclusion criteria
✕. Patients with histologic subtypes other than squamous cell carcinoma in situ (AK or BD).
✕. Patients with tumor extending into the oral cavity, nostrils, eyelids, urethra, anus, vagina or rectum.
✕. Patients who had grossly suspicious or inflamed nodes on physical examination.
✕. Patients with grossly infected tumors.
✕. Patients with recurrent invasive squamous cell carcinoma.
✕. 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.
✕. Use of any investigational drug in the 30 days before screening.
✕
What they're measuring
1
Partial clearance rate
Timeframe: 16 weeks treatment and 4 weeks follow-up