Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02029066
Study type	Interventional
Source	G&E Herbal Biotechnology Co., LTD
Contact
Status	Completed
Phase	Phase 1
Start date	November 2013
Completion date	February 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03013647` - Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization	N/A
Completed	`NCT02674048` - Metvix Daylight PDT in Actinic Keratosis
Completed	`NCT02239679` - Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy	Phase 2
Completed	`NCT02421471` - PMS to Evaluate the Safety and Efficacy of Picato® Gel
Completed	`NCT01686152` - Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis	Phase 3
Terminated	`NCT01525329` - Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease	Phase 3
Completed	`NCT01444989` - Development and Validation of a Quality of Life Instrument for Actinic Keratosis	N/A
Completed	`NCT01449513` - PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy	Phase 1
Terminated	`NCT01203878` - Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy	Phase 4
Completed	`NCT00989313` - A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study	Phase 3
Completed	`NCT00306800` - Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp	Phase 3
Completed	`NCT00375739` - Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses	Phase 2
Completed	`NCT03285490` - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)	Phase 3
Completed	`NCT03319251` - Biomarker Database Registry for Photodynamic Therapy
Completed	`NCT02866695` - Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients	Phase 4
Completed	`NCT02952898` - Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses	Phase 3
Completed	`NCT02984072` - Menthol for PDT Pain Relief	Phase 4
Recruiting	`NCT03684772` - Topical Ionic Contra-Viral Therapy in Actinic Keratosis	Phase 2
Completed	`NCT02878382` - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT	N/A
Completed	`NCT02902822` - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo	N/A