Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by G&E Herbal Biotechnology Co., LTD
Sponsor:
Information provided by (Responsible Party):
G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier:
NCT02029066
First received: October 31, 2013
Last updated: January 5, 2014
Last verified: January 2014
  Purpose

This study is designed to evaluate the pharmacokinetics of solamargine of SR-T100 gel. As safety parameters, adverse events, and vital signs (blood pressure, heart rate, and body temperature) will be recorded.


Condition Intervention Phase
Actinic Keratosis
Drug: SR-T100 gel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-label, Single Dose, Pharmacokinetic Study of SR-T100 Gel (Containing 2.3% Solamargine in Solanum Undatum Plant Extract) in Patients With Actinic Keratosis

Resource links provided by NLM:


Further study details as provided by G&E Herbal Biotechnology Co., LTD:

Primary Outcome Measures:
  • To assess the delivery of SR-T100 from the topical gel by determining the plasma solamargine levels in subjects with AK within a 100 cm^2 treatment area. [ Time Frame: 33 days ] [ Designated as safety issue: No ]
    Twelve Subjects will participate in this study. Each patient will be taken blood samples (6 ml for each) before and after applying of SR-T100 at 0, 0.5, 1, 1.5, 2,2.5, 3, 4, 5, 6, 8, 10,12,16, 20, 24, 28, 34, and 36 hour. Plasma solamargine will be analyzed from blood samples using a bioanalytical method. Pharmacokinetic parameters such as AUC0-t, AUC0-infinity, Cmax Tmax, T½, λz, clearance and MRT will be calculated from plasma concentrations of solamargine and presented in the final report.


Secondary Outcome Measures:
  • Safety parameters (medical history, clinical examinations, laboratory tests and adverse events) will be recorded and reported as appropriate. [ Time Frame: 33 days and 7 days follow up period after complete study. ] [ Designated as safety issue: Yes ]

    Medical history: medical and personal histories will be evaluated by investigators in order to determine whether the subject fulfills the inclusion/exclusion criteria.

    Clinical examinations: vital signs and physical examinations. Blood pressure, heart rate, body temperature in the sitting position, body weight, and height will be measured.

    Laboratory tests: Hematology (Hemoglobin, hematocrit, WBC count with differential, RBC count, and platelet count), Biochemistry (Total protein, SGOT (AST), SGPT (ALT), γ-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, creatinine, uric acid, total cholesterol, and TG), Urinalysis (Specific gravity, ketone body, urine bilirubin, urobilinogen, leukocyte, nitrite, pH, occult blood, glucose, and protein), Serology (Anti-HIV test, HBsAg and Anti-HCV), and Pregnancy test (Urine or serum pregnancy test (for female patients with childbearing potential)).



Estimated Enrollment: 12
Study Start Date: November 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SR-T100 gel
dosage form: topical gel dosage: 2g of 2.3% SR-T100 frequency: once duration: 24 hours
Drug: SR-T100 gel
2g of SR-T100 will topical apply on 100 cm^2 once for 24 hours.
Other Name: SR-T100 gel

Detailed Description:

In the study period, a single dose of 2 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) in 100 cm2 skin area covered by an occlusive dressing will be administered. Sampling Time Schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 20, 24, 36 hours after dosing.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female is 20 years of age or above.
  2. Patient has AK lesions located within a 100 cm2 contiguous or non-contiguous treatment area.
  3. Patient has at least one clinical confirmed AK lesion within the selected treatment area before.

Exclusion Criteria:

  1. Patient had used the following treatments within 4 weeks prior to the study treatment initiation: immunomodulators or immunosuppressive therapy, interferon, cytotoxic drugs.
  2. Patient had treated with topical 5-FU, diclofenac gel, imiquimod, ingenol mebutate, corticosteroids, retinoids, masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
  3. Patient had received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
  4. Patient had received any of the following treatments on the treatment area in the 6 months before study treatment initiation: psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, chemical peel.
  5. 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.
  6. Use of any medication, including over the counter products, herb medicine and dietary supplements such as vitamins, which would interfere with study results, within one week before and during the study course.
  7. Patient is known to be hypersensitive to the study medication.
  8. Female who is pregnant, breast-feeding or considering becoming pregnant while on the study.
  9. 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.
  10. Patient had used of any investigational drug within the past 30 days before enrollment.
  11. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02029066

Contacts
Contact: Kou-Wha Kuo, Ph.D. 886-6-505-2976 ext 201 kwkuo@geherbs.com.tw

Locations
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70403
Contact: Hamm-Ming Sheu, M.D.    886-6-235-3535      
Principal Investigator: Hamm-Ming Sheu, M.D.         
Sponsors and Collaborators
G&E Herbal Biotechnology Co., LTD
Investigators
Principal Investigator: Hamm-Ming Sheu, M.D. National Cheng-Kung University Hospital
  More Information

No publications provided

Responsible Party: G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier: NCT02029066     History of Changes
Other Study ID Numbers: GESRTAKC, 1025023899
Study First Received: October 31, 2013
Last Updated: January 5, 2014
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by G&E Herbal Biotechnology Co., LTD:
actinic keratosis
SR-T100
pharmacokinetics

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014