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Clinical Study Assessment of SR-T100 Topical Gel Against Actinic Keratosis (AK)

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ClinicalTrials.gov Identifier: NCT02085395
Recruitment Status : Completed
First Posted : March 12, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
G&E Herbal Biotechnology Co., LTD

Brief 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%.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Bowen's Disease Drug: SR-T100 ® Gel Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SR-T100 ® Gel
Topical gel containing 2.3% of solamargine in Solanum undatum extract is used once daily with occlusive dressing for 16 weeks.
Drug: SR-T100 ® Gel
Other Name: SR-T100




Primary Outcome Measures :
  1. Partial clearance rate [ Time Frame: 16 weeks treatment and 4 weeks follow-up ]
    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 Outcome Measures :
  1. Complete clearance rate [ Time Frame: 16 weeks treatment and 4 weeks follow-up ]
  2. Partial clearance rate [ Time Frame: 16 weeks treatment and 4 weeks follow-up ]

Other Outcome Measures:
  1. Histological response rate [ Time Frame: 2-16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085395


Locations
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Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Sponsors and Collaborators
G&E Herbal Biotechnology Co., LTD
Investigators
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Principal Investigator: Dr. Hamm-Ming Sheu, MD Department of Dermatology National Cheng Kung University Hospital Tainan, Taiwan, ROC
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Responsible Party: G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier: NCT02085395    
Other Study ID Numbers: MCCD06003A
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014
Keywords provided by G&E Herbal Biotechnology Co., LTD:
Actinic Keratosis, AK, Bowen's Disease, Bowen
Additional relevant MeSH terms:
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Keratosis, Actinic
Bowen's Disease
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell