Actinic KeratosisPhase 2AKNCT02085395
Clinical Study Assessment of SR-T100 Topical Gel Against Actinic Keratosis
A Phase 2 study testing SR-T100 ® Gel in people with Actinic Keratosis and Bowen's Disease, run by G&E Herbal Biotechnology Co., LTD at 1 site in Taiwan.
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%. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Actinic Keratosis, Bowen's Disease
- What is being tested?
- SR-T100 ® Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2007to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients met ALL of the inclusion criteria for the entry of this study:
- 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.
Who cannot join
- Patients were excluded from this study for ANY of the following reasons:
- 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.
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- 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.
- Pregnant or lactating women or women of childbearing potential using inadequate contraceptive methods.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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%.
Read the 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.
- Conditions
- Actinic Keratosis, Bowen's Disease
- Being tested
- SR-T100 ® Gel
- Keywords
- Actinic Keratosis, AK, Bowen's Disease, Bowen
- Medical subject headings
- Keratosis, Actinic, Bowen's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR-T100 ® GelDrug
Also called SR-T100
| Study group | Role | What they receive |
|---|---|---|
| SR-T100 ® Gel | Experimental | Topical gel containing 2.3% of solamargine in Solanum undatum extract is used once daily with occlusive dressing for 16 weeks. Receives: Drug: SR-T100 ® Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 16 weeks treatment and 4 weeks follow-up
Secondary outcomes (2)
Complete clearance rate
Measured: 16 weeks treatment and 4 weeks follow-up
Partial clearance rate
Measured: 16 weeks treatment and 4 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startNov 2007
- Primary completionApr 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- G&E Herbal Biotechnology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Hamm-Ming Sheu, MD, Principal investigator, Department of Dermatology National Cheng Kung University Hospital Tainan, Taiwan, ROC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085395
- Sponsor's protocol ID
- MCCD06003A
- Acronym
- AK
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2014
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02085395
- Acronym / sponsor ID
- AK / MCCD06003A
- Conditions
- Actinic Keratosis, Bowen's Disease
- Keywords
- Actinic Keratosis, AK, Bowen's Disease, Bowen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- G&E Herbal Biotechnology Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SR-T100 ® Gel | Experimental | Drug: SR-T100 ® GelTopical gel containing 2.3% of solamargine in Solanum undatum extract is used once daily with occlusive dressing for 16 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients met ALL of the inclusion criteria for the entry of this study:
Key exclusion criteria (9 listed)
- Patients were excluded from this study for ANY of the following reasons:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR-T100 ® GelAlso: SR-T100 | Drug | SR-T100 ® Gel |
Primary outcome
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%.
2 secondary outcomes
Complete clearance rate
Time frame: 16 weeks treatment and 4 weeks follow-up
Partial clearance rate
Time frame: 16 weeks treatment and 4 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Hamm-Ming Sheu, MD principal investigator
Department of Dermatology National Cheng Kung University Hospital Tainan, Taiwan, ROC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SR-T100 ® Gel in people with Actinic Keratosis and Bowen's Disease, run by G&E Herbal Biotechnology Co., LTD at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial clearance rate (time frame: 16 weeks treatment and 4 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2014.