Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02085395
Other study ID # MCCD06003A
Secondary ID
Status Completed
Phase Phase 2
First received March 11, 2014
Last updated March 13, 2014
Start date November 2007
Est. completion date November 2010

Study information

Verified date March 2014
Source G&E Herbal Biotechnology Co., LTD
Contact n/a
Is FDA regulated No
Health authority Taiwan : Food and Drug Administration
Study type Interventional

Clinical Trial 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%.


Description:

An open phase II study to assess the efficacy and safety of topical SR-T100 gel in the treatment of human cutaneous cell carcinoma in situ (Actinic Keratosis and Bowen's Disease). The primary efficacy endpoint defines as the proportion of patients whose lesion size reduced at least 75%. The secondary efficacy endpoints include complete clearance rate as the proportion of patients with no clinical visible AK/BD lesions in the treatment area, partial clearance rate as the proportion of patients at least a 75% reduction of AK/BD lesion size in teh treatment area, and histological response rate as the proportion of patients with biopsy proven clearance of AK and BD in situ. Safety was evaluated by clinically significant changes occurring from baseline to the end of the study by observing physical examination, vital signs, laboratory assessments and AEs.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date November 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
SR-T100 ® Gel


Locations

Country Name City State
Taiwan National Cheng Kung University Hospital Tainan

Sponsors (1)

Lead Sponsor Collaborator
G&E Herbal Biotechnology Co., LTD

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Histological response rate 2-16 weeks Yes
Primary Partial clearance rate 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%. 16 weeks treatment and 4 weeks follow-up Yes
Secondary Complete clearance rate 16 weeks treatment and 4 weeks follow-up Yes
Secondary Partial clearance rate 16 weeks treatment and 4 weeks follow-up Yes
See also
  Status Clinical Trial Phase
Recruiting NCT03013647 - Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization N/A
Completed NCT02674048 - Metvix Daylight PDT in Actinic Keratosis
Completed NCT02239679 - Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy Phase 2
Completed NCT02421471 - PMS to Evaluate the Safety and Efficacy of Picato® Gel
Completed NCT01686152 - Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis Phase 3
Completed NCT01449513 - PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy Phase 1
Completed NCT01444989 - Development and Validation of a Quality of Life Instrument for Actinic Keratosis N/A
Terminated NCT01525329 - Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease Phase 3
Terminated NCT01203878 - Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy Phase 4
Completed NCT00989313 - A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study Phase 3
Completed NCT00306800 - Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp Phase 3
Completed NCT00375739 - Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses Phase 2
Completed NCT03285490 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004) Phase 3
Completed NCT03319251 - Biomarker Database Registry for Photodynamic Therapy
Completed NCT02866695 - Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients Phase 4
Completed NCT02952898 - Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses Phase 3
Completed NCT02984072 - Menthol for PDT Pain Relief Phase 4
Recruiting NCT03684772 - Topical Ionic Contra-Viral Therapy in Actinic Keratosis Phase 2
Completed NCT02938715 - Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil N/A
Completed NCT02902822 - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo N/A