Vulvar Intraepithelial NeoplasiaEarly Phase 1NCT01676792
SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma
A Early Phase 1 study testing SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in people with Vulvar Intraepithelial Neoplasia and Genital Warts, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
This pilot clinical study is to evaluate the efficacy \& safety of SR-T100 gel (2.3% of SM in Solanum undatum plant extract) in patients with VIN(s) or EGW(s). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Vulvar Intraepithelial Neoplasia, Genital Warts
- What is being tested?
- SR-T100 gel with 2.3% of SM in Solanum undatum plant extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2011to Oct 2013
- Phase
- Early Phase 1
- 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
(EGW group)Inclusion Criteria:
- Male \& female patients older than 20 years old presents at least one pathologically confirmed with histopathology EGW with lesion size greater than 5mm in diameter. (EGW group)Exclusion Criteria:
- Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell carcinoma, having treated with other investigational drugs within 30 days, pregnancy \& lactating females, female with pregnancy potential without using effective boundary barrier or patients with immune-deficience. (VIN group)Inclusion Criteria:
- Female patients older than 20 years old presents at least one histopathologically confirmed VIN with lesion size greater than 5mm in diameter. (VIN group)Exclusion Criteria:
- Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell carcinoma, having treated with other investigational drugs within 30 days, pregnancy \& lactating females, female with pregnancy potential without using effective boundary barrier or patients with immune-deficience.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Efficacy & Safety of Topical SR-T100 Gel in the Treatment of Human Vulva Pre-cancerous Lesions (Vulvar Intraepithelial Neoplasia; VIN) & Cutaneous Condyloma(External Genital Warts; EGWs)
This pilot clinical study is to evaluate the efficacy \& safety of SR-T100 gel (2.3% of SM in Solanum undatum plant extract) in patients with VIN(s) or EGW(s).
Read the detailed description
An open-label, pilot study to evaluate the efficacy \& safety profiles of SR-T100 gel in treating patients with VINs or EGWs. Male \& female older than 20 years old have at least one VIN or EGW with lesion size greater than 5 mm in diameter are candidates for this study. The primary endpoint is evaluated based on patients who has received 16-week treatment and presents evaluable measurement datas by the end of 20th week. The secondary endpoints will be evaluated based on all patients with measurable values for VINs or EGWs, recruited patients in this study has never had experiencs associated with prior SR-T100 treatment of any sorts during their life time before becoming a participant in this study. The study plans to recruit 20 patients with VINs or EGWs, the enrollment duration will last two years with total of 40 patients involved.
- Conditions
- Vulvar Intraepithelial Neoplasia, Genital Warts
- Being tested
- SR-T100 gel with 2.3% of SM in Solanum undatum plant extract
- Keywords
- condyloma acuminate, ano-genital warts, genital warts, cutaneous condyloma, Vulva pre-cancerous lesions, Vulvar Intraepitheral Neoplasia, VIN, EGW
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR-T100 gel with 2.3% of SM in Solanum undatum plant extractDrug
Also called SR-T100 gel
Self administered topical SR-T100 gel on lesion(s) including its peripheral normal skin approximately 1cm around the lesion with the amount of 0.02 g/cm squared with occlusive dressing once daily. Patients who is unable to tolerate with occlusive dressing is instructed 3 times daily in the morning, afternoon \& before bed time. Medication should be reapply after bathing or cleaning.
| Study group | Role | What they receive |
|---|---|---|
| Lesion reduction | Experimental | Not described Receives: Drug: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients achieve greater than or equal to 75% lesion size reduction
Proportion of patients achieving greater than or equivalent to 75% lesion size reduction from baseline on the 20th week after 16 weeks of SR-T100 gel treatment
Measured: 20 weeks (16 weeks treatment period + 4 weeks follow-up period)
Secondary outcomes (2)
Total clearance rate
Proportions of patient with treated VIN(s) or EGW(s) completely eradicate.
Measured: 20 weeks (16 weeks treatment period + 4 weeks follow-up period)
Partial clearance rate
Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline.
Measured: 20 weeks (16weeks treatment period + 4 weeks follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- G&E Herbal Biotechnology Co., LTD
- Responsible party
- Sponsor
- Investigators
- Keng-Fu Hsu, MD, PhD., Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676792
- Sponsor's protocol ID
- 100CT221
- Other IDs
- 100CT221
- Status last verified
- Apr 2014
- First submitted
- 29 Aug 2012
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Efficacy & Safety of Topical SR-T100 Gel in the Treatment of Human Vulva Pre-cancerous Lesions (Vulvar Intraepithelial Neoplasia; VIN) & Cutaneous Condyloma(External Genital Warts; EGWs)
- ClinicalTrials.gov ID
- NCT01676792
- Acronym / sponsor ID
- 100CT221
- Conditions
- Vulvar Intraepithelial Neoplasia, Genital Warts
- Keywords
- condyloma acuminate, ano-genital warts, genital warts, cutaneous condyloma, Vulva pre-cancerous lesions, Vulvar Intraepitheral Neoplasia, VIN, EGW
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- G&E Herbal Biotechnology Co., LTD
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 31 Aug 2012 (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.
This pilot clinical study is to evaluate the efficacy \& safety of SR-T100 gel (2.3% of SM in Solanum undatum plant extract) in patients with VIN(s) or EGW(s).
Detailed description
An open-label, pilot study to evaluate the efficacy \& safety profiles of SR-T100 gel in treating patients with VINs or EGWs. Male \& female older than 20 years old have at least one VIN or EGW with lesion size greater than 5 mm in diameter are candidates for this study. The primary endpoint is evaluated based on patients who has received 16-week treatment and presents evaluable measurement datas by the end of 20th week. The secondary endpoints will be evaluated based on all patients with measurable values for VINs or EGWs, recruited patients in this study has never had experiencs associated with prior SR-T100 treatment of any sorts during their life time before becoming a participant in this study. The study plans to recruit 20 patients with VINs or EGWs, the enrollment duration will last two years with total of 40 patients involved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lesion reduction | Experimental | Drug: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 gel with 2.3% of SM in Solanum undatum plant extractAlso: SR-T100 gelSelf administered topical SR-T100 gel on lesion(s) including its peripheral normal skin approximately 1cm around the lesion with the amount of 0.02 g/cm squared with occlusive dressing once daily. Patients who is unable to tolerate with occlusive dressing is instructed 3 times daily in the morning, afternoon \& before bed time. Medication should be reapply after bathing or cleaning. | Drug | Lesion reduction |
Primary outcome
Patients achieve greater than or equal to 75% lesion size reduction
Time frame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period)
Proportion of patients achieving greater than or equivalent to 75% lesion size reduction from baseline on the 20th week after 16 weeks of SR-T100 gel treatment
2 secondary outcomes
Total clearance rate
Time frame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period)
Partial clearance rate
Time frame: 20 weeks (16weeks treatment period + 4 weeks follow-up period
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 22 Apr 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.
Keng-Fu Hsu, MD, PhD. principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in people with Vulvar Intraepithelial Neoplasia and Genital Warts, run by National Cheng-Kung University Hospital 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?
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 22 Apr 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Patients achieve greater than or equal to 75% lesion size reduction (time frame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period)). 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 22 Apr 2014.