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Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis

NCT02559934 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-07-15

No results posted yet for this study

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.

Conditions

  • Actinic Keratosis

Interventions

DRUG

SR-T100 Gel

0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract)

Sponsors & Collaborators

  • G&E Herbal Biotechnology Co., LTD

    lead INDUSTRY

Principal Investigators

  • Kou-Wha Kuo, PhD · G&E Herbal Biotechnology Co., LTD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-01-31
Completion
2019-05-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02559934 on ClinicalTrials.gov