Actinic KeratosisPhase 1NCT02559934
Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
A Phase 1 study testing SR-T100 Gel in people with Actinic Keratosis, run by G&E Herbal Biotechnology Co., LTD at 1 site in Taiwan.
Trial summary
The aim of this study is to assess the delivery of SR-T100 from the topical gel (containing 2.3% solamargine in Solanum undatum plant extract) by determining the plasma levels of solamargine in subjects with AK while administration of a 25 cm2 contiguous or non-contiguous dermal treatment area. 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
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2015to May 2019
- Phase
- 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
Who may be able to join
- Male or female is 20 years of age or above.
- Patient has AK lesions located within a 25 cm2 contiguous or non-contiguous treatment area.
- Patient has at least one clinical confirmed AK lesion within the selected treatment area before.
Who cannot join
- Patient had used the following treatments within 4 weeks prior to the study treatment initiation: immunomodulators or immunosuppressive therapy, interferon or cytotoxic drugs.
- Patient had treated with topical 5-FU, diclofenac gel, imiquimod, ingenol mebutate, corticosteroids, retinoids or masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
- Patient had received cryodestruction, chemodestruction, curettage, photodynamic therapy or 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 the 6 months before study treatment initiation: psoralen plus Ultraviolet A therapy, Ultraviolet B therapy, laser abrasion, dermabrasion, chemical peel.
- Patient had used any topical preparations, such as sunscreens, moisturizers, body oils, or alpha or beta hydroxyl acids, in the treatment area within 24 hours before and during the study course.
- Patient is known to be hypersensitive to the study medication.
Show all 10Show fewer
- Female who is pregnant, breast-feeding or considering becoming pregnant while during the study.
- Donation of 500 ml of blood in the past 3 months prior to dosing or donation of 250 ml of blood in the past 2 months prior to dosing.
- Patient had used of any investigational drug within the past 30 days before enrollment.
- Patient has any dermatological disease and/or 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 (5 cm distances from treatment area).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multiple-dose, Pharmacokinetic Study of SR-T100 Gel (Containing 2.3% Solamargine in Solanum Undatum Plant Extract) in Patients With Actinic Keratosis
The aim of this study is to assess the delivery of SR-T100 from the topical gel (containing 2.3% solamargine in Solanum undatum plant extract) by determining the plasma levels of solamargine in subjects with AK while administration of a 25 cm2 contiguous or non-contiguous dermal treatment area.
Read the detailed description
It is an open-label, multiple-dose, pharmacokinetic study. In stage 1, plasma concentration of solamargine will be examined after the test products were administrated to 5 subjects with Actinic Keratosis (AK). Thereafter, an interim report based on the results of stage 1 will be submitted for Taiwan Center for Drug Evaluation (CDE) review to determine stage 2 will be conducted or not. For stage 2, another 5 subjects with AK will be enrolled to complete the study.
The subjects will be recruited from AK patients of Taiwan. All subjects will sign an informed consent form (ICF). A copy of the signed ICF will be handed to the subjects. The subjects will be screened on an outpatient basis within 1 month prior to entry according to defined inclusion and exclusion criteria (medical history, personal history, physical examination, and laboratory values). The subject must be qualified for the study by fulfilling all of the inclusion and none of the exclusion criteria.
In the study period, study drug will be given once daily for sixteen consecutive weeks. Specifically, subjects will receive a single dose of 0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) in 25 cm2 skin area covered by occlusive dressing at least 20 hours a day.
- Conditions
- Actinic Keratosis
- Being tested
- 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
Also called Solamargine
0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract)
| Study group | Role | What they receive |
|---|---|---|
| SR-T100 gel | Experimental | A single dose of 0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) in 25 cm2 skin area covered by an occlusive dressing at least 20 hours a day and will be given once daily for sixteen consecutive weeks. Receives: Drug: SR-T100 Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-τ,ss;
AUC0-τ,ss was determined by the area under the plasma concentration-time curve during a dosing interval at the last dose determined by the trapezoidal rule
Measured: sixteen consecutive weeks.
AUMC0-τ,ss
AUMC0-τ,ss was determined by the area under the plasma (first) moment concentration-time curve during a dosing interval at the last dose determined by the trapezoidal rule according to the following equation:
AUMC0-τ,ss = Σ[(tn - tn-1)(Cn-1tn-1 + Cntn) /2]
Measured: sixteen consecutive weeks.
Cmax,ss;
Cmax,ss was determined by the the highest observed plasma concentration at steady state (the last dosing interval)
Measured: sixteen consecutive weeks.
Cmin,ss;
Cmin,ss was determined by the minimum observed plasma concentration at steady state
Measured: sixteen consecutive weeks.
Cave,ss
Cave,ss was determined by the average plasma concentration at steady state (the last dosing interval) according to the following equation:
Cave,ss = AUCss / dosing interval
Measured: sixteen consecutive weeks.
Fluctuation
Fluctuation was determined by the Fluctuation index of concentration at steady state
Measured: sixteen consecutive weeks.
Tmax,ss;
Tmax,ss was determined by the time to reach highest observed plasma concentration at steady state (the last dosing interval)
Measured: sixteen consecutive weeks.
kel
kel was determined by the plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration
Measured: sixteen consecutive weeks.
T½;
T½ was determined by the plasma half-life estimated by (0.693/kel)
Measured: sixteen consecutive weeks.
MRTss
MRTss was determined by the mean residence time determined by AUMC0-τ,ss / AUC0-τ,ss
Measured: sixteen consecutive weeks.
Secondary outcomes (1)
Adverse events will be recorded to evaluate the safety outcome.
Measured: sixteen consecutive weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2019
- Study completionMay 2019
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- G&E Herbal Biotechnology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kou-Wha Kuo, PhD, Study director, G&E Herbal Biotechnology Co., LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559934
- Sponsor's protocol ID
- GESRTAKD
- Status last verified
- Jul 2019
- First submitted
- 11 Aug 2015
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dose, Pharmacokinetic Study of SR-T100 Gel (Containing 2.3% Solamargine in Solanum Undatum Plant Extract) in Patients With Actinic Keratosis
- ClinicalTrials.gov ID
- NCT02559934
- Acronym / sponsor ID
- GESRTAKD
- Conditions
- Actinic Keratosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- G&E Herbal Biotechnology Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 25 Sep 2015 (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.
The aim of this study is to assess the delivery of SR-T100 from the topical gel (containing 2.3% solamargine in Solanum undatum plant extract) by determining the plasma levels of solamargine in subjects with AK while administration of a 25 cm2 contiguous or non-contiguous dermal treatment area.
Detailed description
It is an open-label, multiple-dose, pharmacokinetic study. In stage 1, plasma concentration of solamargine will be examined after the test products were administrated to 5 subjects with Actinic Keratosis (AK). Thereafter, an interim report based on the results of stage 1 will be submitted for Taiwan Center for Drug Evaluation (CDE) review to determine stage 2 will be conducted or not. For stage 2, another 5 subjects with AK will be enrolled to complete the study.
The subjects will be recruited from AK patients of Taiwan. All subjects will sign an informed consent form (ICF). A copy of the signed ICF will be handed to the subjects. The subjects will be screened on an outpatient basis within 1 month prior to entry according to defined inclusion and exclusion criteria (medical history, personal history, physical examination, and laboratory values). The subject must be qualified for the study by fulfilling all of the inclusion and none of the exclusion criteria.
In the study period, study drug will be given once daily for sixteen consecutive weeks. Specifically, subjects will receive a single dose of 0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) in 25 cm2 skin area covered by occlusive dressing at least 20 hours a day.
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 GelA single dose of 0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) in 25 cm2 skin area covered by an occlusive dressing at least 20 hours a day and will be given once daily for sixteen consecutive weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female is 20 years of age or above.
- Patient has AK lesions located within a 25 cm2 contiguous or non-contiguous treatment area.
- Patient has at least one clinical confirmed AK lesion within the selected treatment area before.
Key exclusion criteria (10 listed)
- Patient had used the following treatments within 4 weeks prior to the study treatment initiation: immunomodulators or immunosuppressive therapy, interferon or cytotoxic drugs.
- Patient had treated with topical 5-FU, diclofenac gel, imiquimod, ingenol mebutate, corticosteroids, retinoids or masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
- Patient had received cryodestruction, chemodestruction, curettage, photodynamic therapy or 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 the 6 months before study treatment initiation: psoralen plus Ultraviolet A therapy, Ultraviolet B therapy, laser abrasion, dermabrasion, chemical peel.
- Patient had used any topical preparations, such as sunscreens, moisturizers, body oils, or alpha or beta hydroxyl acids, in the treatment area within 24 hours before and during the study course.
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: Solamargine0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) | Drug | SR-T100 gel |
Primary outcome
AUC0-τ,ss;
Time frame: sixteen consecutive weeks.
AUC0-τ,ss was determined by the area under the plasma concentration-time curve during a dosing interval at the last dose determined by the trapezoidal rule
AUMC0-τ,ss
Time frame: sixteen consecutive weeks.
AUMC0-τ,ss was determined by the area under the plasma (first) moment concentration-time curve during a dosing interval at the last dose determined by the trapezoidal rule according to the following equation: AUMC0-τ,ss = Σ[(tn - tn-1)(Cn-1tn-1 + Cntn) /2]
Cmax,ss;
Time frame: sixteen consecutive weeks.
Cmax,ss was determined by the the highest observed plasma concentration at steady state (the last dosing interval)
Cmin,ss;
Time frame: sixteen consecutive weeks.
Cmin,ss was determined by the minimum observed plasma concentration at steady state
Cave,ss
Time frame: sixteen consecutive weeks.
Cave,ss was determined by the average plasma concentration at steady state (the last dosing interval) according to the following equation: Cave,ss = AUCss / dosing interval
Fluctuation
Time frame: sixteen consecutive weeks.
Fluctuation was determined by the Fluctuation index of concentration at steady state
Tmax,ss;
Time frame: sixteen consecutive weeks.
Tmax,ss was determined by the time to reach highest observed plasma concentration at steady state (the last dosing interval)
kel
Time frame: sixteen consecutive weeks.
kel was determined by the plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration
T½;
Time frame: sixteen consecutive weeks.
T½ was determined by the plasma half-life estimated by (0.693/kel)
MRTss
Time frame: sixteen consecutive weeks.
MRTss was determined by the mean residence time determined by AUMC0-τ,ss / AUC0-τ,ss
1 secondary outcome
Adverse events will be recorded to evaluate the safety outcome.
Time frame: sixteen consecutive 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 15 Jul 2019.
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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.
Kou-Wha Kuo, PhD study director
G&E Herbal Biotechnology Co., LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SR-T100 Gel in people with Actinic Keratosis, 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 3 inclusion and 10 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 15 Jul 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AUC0-τ,ss; (time frame: sixteen consecutive weeks.). The study lists 10 primary outcomes in all. 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 15 Jul 2019.