Back to resultsMultiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
SR-T100 Gel
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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).
Sites / Locations
- National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SR-T100 gel
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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]
Cmax,ss;
Cmax,ss was determined by the the highest observed plasma concentration at steady state (the last dosing interval)
Cmin,ss;
Cmin,ss was determined by the minimum observed plasma concentration at steady state
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
Fluctuation
Fluctuation was determined by the Fluctuation index of concentration at steady state
Tmax,ss;
Tmax,ss was determined by the time to reach highest observed plasma concentration at steady state (the last dosing interval)
kel
kel was determined by the plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration
T½;
T½ was determined by the plasma half-life estimated by (0.693/kel)
MRTss
MRTss was determined by the mean residence time determined by AUMC0-τ,ss / AUC0-τ,ss
Secondary Outcome Measures
Adverse events will be recorded to evaluate the safety outcome.
Full Information
NCT ID
NCT02559934
First Posted
August 11, 2015
Last Updated
July 12, 2019
Sponsor
G&E Herbal Biotechnology Co., LTD
1. Study Identification
Unique Protocol Identification Number
NCT02559934
Brief Title
Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
G&E Herbal Biotechnology Co., LTD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SR-T100 gel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SR-T100 Gel
Other Intervention Name(s)
Solamargine
Intervention Description
0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract)
Primary Outcome Measure Information:
Title
AUC0-τ,ss;
Description
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
Time Frame
sixteen consecutive weeks.
Title
AUMC0-τ,ss
Description
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]
Time Frame
sixteen consecutive weeks.
Title
Cmax,ss;
Description
Cmax,ss was determined by the the highest observed plasma concentration at steady state (the last dosing interval)
Time Frame
sixteen consecutive weeks.
Title
Cmin,ss;
Description
Cmin,ss was determined by the minimum observed plasma concentration at steady state
Time Frame
sixteen consecutive weeks.
Title
Cave,ss
Description
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
Time Frame
sixteen consecutive weeks.
Title
Fluctuation
Description
Fluctuation was determined by the Fluctuation index of concentration at steady state
Time Frame
sixteen consecutive weeks.
Title
Tmax,ss;
Description
Tmax,ss was determined by the time to reach highest observed plasma concentration at steady state (the last dosing interval)
Time Frame
sixteen consecutive weeks.
Title
kel
Description
kel was determined by the plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration
Time Frame
sixteen consecutive weeks.
Title
T½;
Description
T½ was determined by the plasma half-life estimated by (0.693/kel)
Time Frame
sixteen consecutive weeks.
Title
MRTss
Description
MRTss was determined by the mean residence time determined by AUMC0-τ,ss / AUC0-τ,ss
Time Frame
sixteen consecutive weeks.
Secondary Outcome Measure Information:
Title
Adverse events will be recorded to evaluate the safety outcome.
Time Frame
sixteen consecutive weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kou-Wha Kuo, PhD
Organizational Affiliation
G&E Herbal Biotechnology Co., LTD
Official's Role
Study Director
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
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