NCT02559934

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

Completed Phase 1 Last updated 12 July 2019

What this trial tests

Phase 1 trial testing SR-T100 Gel in Actinic Keratosis in 12 participants. Completed in 1 May 2019.

Timeline

1 November 2015

Primary endpoint
1 January 2019

1 May 2019

Quick facts

Lead sponsor	G&E Herbal Biotechnology Co., LTD
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 November 2015
Primary completion	1 January 2019
Estimated completion	1 May 2019
Sites	1 location across Taiwan

Drugs / interventions tested

• SR-T100 Gel — full drug profile →

Conditions studied

• Actinic Keratosis — all drugs for Actinic Keratosis →

Sponsor

G&E Herbal Biotechnology Co., LTD — full company profile →

Who can join

20 and older, any sex, with Actinic Keratosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Integration of botanicals in contemporary medicine: road blocks, checkpoints and go-ahead signals.
   Chugh NA, Bali S, Koul A. · · 2018 · cited 26× · PMID 29989061 · DOI 10.1016/j.imr.2018.03.005