Actinic KeratosisPhase 3NCT01493921
Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment
A Phase 3 study testing SR-T100 gel in people with Actinic Keratosis, run by G&E Herbal Biotechnology Co., LTD at 6 sites in Taiwan.
Trial summary
Studies of SR-T100 gel and its clinical relevance in the treatment of AK, providing adequate measured outcomes for skin lesion treatment. In addition to the high complete response rate (90.0%) as compared with the conventional therapy, the most significant result was that no undesirable side effects were associated… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- SR-T100 gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 6 sitesTaiwan
- Study dates
- Oct 2011to Nov 2015
- Phase
- Phase 3
- 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
- Male or female is 20 years of age or above and patient has at least two clinically visible, discrete, non hyperkeratotic, hypertrophic AK lesions located within a 25 cm squared contiguous or non contiguous treatment area including the arms, shoulder, chest, face and scalp. Patient has at least one histological confirmed actinic keratosis lesion of greater or equal to 4 mm in diameter within the selected treatment area.
Who cannot join
- Patient has any dermatological disease and condition, such as atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma, or other possible confounding skin conditions in the treatment or surrounding area within 5cm distances from treatment area.
- Patient had used the following treatments within 4 weeks prior to the study treatment initiation as immunomodulators or immunosuppressive therapy,interferon and cytotoxic drugs.
- Patient treated with topical 5 FU, diclofenac gel, imiquimod, corticosteroids, retinoids, masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
- Patient received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
- Patient had received any of the following treatments on the treatment area in 6 months before study treatment initiation begins, such as psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion chemical peel.
- Patient is known to be hypersensitive to the study medication.
- Female who is pregnant, breast fed or considers of becoming pregnant while on the study.
- Patient had used of any investigational drug within the past 30 days before enrollment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Chiayi Chang Gung Memorial Hospital
Chiayi City
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
Chi Mei Medical Center YongKang
Tainan
National Cheng Kung University Hospital
Tainan
About this study
Official title: A Randomized, Double-Blind, Parallel, Vehicle-Controlled Phase III Trial to Assess the Efficacy and Safety of Topical SR-T100 Gel in the Treatment of Patients With Actinic Keratosis
Studies of SR-T100 gel and its clinical relevance in the treatment of AK, providing adequate measured outcomes for skin lesion treatment. In addition to the high complete response rate (90.0%) as compared with the conventional therapy, the most significant result was that no undesirable side effects were associated with the use of SR-T100 gel. The result also shows approximately 80% of study subjects had a complete response in phase II clinical trial conducted in Taiwan; hence, result from our study model suggested SR-T100 gel offers beneficial therapeutic values in treatment of AK is harmless to the skin as well as high tolerance level displayed by majority of patients.
Read the detailed description
The primary objective of this study is to demonstrate a clinically significant outcome involving SR-T100 topical gel developed against skin lesions such as AK. Furthermore, evaluation of SR-T100 efficacy \& tolerability in treating AK lesions are developed as secondary objective in this clinical study. Patients with at least two clinically visible, discrete, non-hyperkeratotic, non-hypertrophic AK lesions on the arms, shoulder, chest, face and or scalp and at least one lesion of greater than or equal to 4mm in diameter within a total of 25 cm squared contiguous or non-contiguous treatment are expected to be enrolled. Candidate pool is then divided into two groups with random assignments of treatment group or placebo group. This randomization scheme will be generated by biostatistics and produced by a computer software program that incorporates a standard procedure for generating random probabilities. Study procedures include laboratory testings, analytical readings as well as clinical assessment practices for treatment efficacy and safety evaluations.
- Conditions
- Actinic Keratosis
- Being tested
- SR-T100 gel, Vehicle gel
- Keywords
- SR-T100 Clinical treatment against Actinic Keratosis, Actinic keratosis skin lesion treatment with SR-T100 gel, Skin lesion treatment with SR-T100 gel, SR-T100 gel treatment against skin lesion, Clinical efficacy study of SR-T100 gel
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR-T100 gelDrug
Patient will be instructed to self-apply approximately 0.3~0.5g of SR-T100 gel on 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.
Vehicle gelDrug
Patient wil be instructed to self-apply approximately 0.3~0.5g of vehicle gel (without active ingredient)per total of 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.
| Study group | Role | What they receive |
|---|---|---|
| SR-T100 gel | Experimental | Patient group receiving medication SR-T100 gel with active ingredient under investigation, enrolled subjects randomly assigned to this group to accurately depict statistical significance of the measured outcome. Receives: Drug: SR-T100 gel |
| Vehicle gel | Active comparator | Patients given placebo with non-SR-T100 ingredients as they are being administered to patients, subjects are under random assignments from patient pool to depict statistically significant outcome measurement. Receives: Drug: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of SR-T100 gel effect with those of vehicle gel (Placebo) on efficacy and tolerability in patients with actinic keratosis
The primary objective is to compare the complete clearance rate between treatment groups at 8 weeks after the completion of 16 weeks study treatment. The primary efficacy endpoint is to evaluate the complete clearance rate at 8 weeks after the completion of 16 weeks study treatment between treatment groups. The complete clearance is defined as the absence of visible or palpable AK lesions in the treatment area
Measured: 24 weeks
Secondary outcomes (1)
Evaluation of efficacy and tolerability of SR-T100 gel in AK treatment
SR-T100 clinical application in Actinic Keratosis treatment as direct proportional relationship to lesion size reduction, complete \& partial clearance defined consequently as 100% \& ≧75% reduction, coordinated toxicity \& bio-safety reports supplements additional case study basis \& foundation.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2015
- Study completionNov 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- G&E Herbal Biotechnology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hamm-Ming Sheu, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493921
- Sponsor's protocol ID
- GESRTAKA
- Status last verified
- Feb 2016
- First submitted
- 15 Dec 2011
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel, Vehicle-Controlled Phase III Trial to Assess the Efficacy and Safety of Topical SR-T100 Gel in the Treatment of Patients With Actinic Keratosis
- ClinicalTrials.gov ID
- NCT01493921
- Acronym / sponsor ID
- GESRTAKA
- Conditions
- Actinic Keratosis
- Keywords
- SR-T100 Clinical treatment against Actinic Keratosis, Actinic keratosis skin lesion treatment with SR-T100 gel, Skin lesion treatment with SR-T100 gel, SR-T100 gel treatment against skin lesion, Clinical efficacy study of SR-T100 gel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- G&E Herbal Biotechnology Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Dec 2011 (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.
Studies of SR-T100 gel and its clinical relevance in the treatment of AK, providing adequate measured outcomes for skin lesion treatment. In addition to the high complete response rate (90.0%) as compared with the conventional therapy, the most significant result was that no undesirable side effects were associated with the use of SR-T100 gel. The result also shows approximately 80% of study subjects had a complete response in phase II clinical trial conducted in Taiwan; hence, result from our study model suggested SR-T100 gel offers beneficial therapeutic values in treatment of AK is harmless to the skin as well as high tolerance level displayed by majority of patients.
Detailed description
The primary objective of this study is to demonstrate a clinically significant outcome involving SR-T100 topical gel developed against skin lesions such as AK. Furthermore, evaluation of SR-T100 efficacy \& tolerability in treating AK lesions are developed as secondary objective in this clinical study. Patients with at least two clinically visible, discrete, non-hyperkeratotic, non-hypertrophic AK lesions on the arms, shoulder, chest, face and or scalp and at least one lesion of greater than or equal to 4mm in diameter within a total of 25 cm squared contiguous or non-contiguous treatment are expected to be enrolled. Candidate pool is then divided into two groups with random assignments of treatment group or placebo group. This randomization scheme will be generated by biostatistics and produced by a computer software program that incorporates a standard procedure for generating random probabilities. Study procedures include laboratory testings, analytical readings as well as clinical assessment practices for treatment efficacy and safety evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SR-T100 gel | Experimental | Drug: SR-T100 gelPatient group receiving medication SR-T100 gel with active ingredient under investigation, enrolled subjects randomly assigned to this group to accurately depict statistical significance of the measured outcome. |
| Vehicle gel | Active comparator | Drug: Vehicle gelPatients given placebo with non-SR-T100 ingredients as they are being administered to patients, subjects are under random assignments from patient pool to depict statistically significant outcome measurement. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female is 20 years of age or above and patient has at least two clinically visible, discrete, non hyperkeratotic, hypertrophic AK lesions located within a 25 cm squared contiguous or non contiguous treatment area including the arms, shoulder, chest, face and scalp. Patient has at least one histological confirmed actinic keratosis lesion of greater or equal to 4 mm in diameter within the selected treatment area.
Key exclusion criteria (8 listed)
- Patient has any dermatological disease and condition, such as atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma, or other possible confounding skin conditions in the treatment or surrounding area within 5cm distances from treatment area.
- Patient had used the following treatments within 4 weeks prior to the study treatment initiation as immunomodulators or immunosuppressive therapy,interferon and cytotoxic drugs.
- Patient treated with topical 5 FU, diclofenac gel, imiquimod, corticosteroids, retinoids, masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
- Patient received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
- Patient had received any of the following treatments on the treatment area in 6 months before study treatment initiation begins, such as psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion chemical peel.
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 gelPatient will be instructed to self-apply approximately 0.3~0.5g of SR-T100 gel on 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period. | Drug | SR-T100 gel |
| Vehicle gelPatient wil be instructed to self-apply approximately 0.3~0.5g of vehicle gel (without active ingredient)per total of 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period. | Drug | Vehicle gel |
Primary outcome
Comparison of SR-T100 gel effect with those of vehicle gel (Placebo) on efficacy and tolerability in patients with actinic keratosis
Time frame: 24 weeks
The primary objective is to compare the complete clearance rate between treatment groups at 8 weeks after the completion of 16 weeks study treatment. The primary efficacy endpoint is to evaluate the complete clearance rate at 8 weeks after the completion of 16 weeks study treatment between treatment groups. The complete clearance is defined as the absence of visible or palpable AK lesions in the treatment area
1 secondary outcome
Evaluation of efficacy and tolerability of SR-T100 gel in AK treatment
Time frame: 24 weeks
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 19 Feb 2016.
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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.
Hamm-Ming Sheu, MD principal investigator
National Cheng-Kung University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SR-T100 gel in people with Actinic Keratosis, run by G&E Herbal Biotechnology Co., LTD at 6 sites 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 1 inclusion and 8 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 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Comparison of SR-T100 gel effect with those of vehicle gel (Placebo) on efficacy and tolerability in patients with actinic keratosis (time frame: 24 weeks). 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 19 Feb 2016.