NCT01493921

A Randomized, Double-Blind, Parallel, Vehicle-Controlled Phase III Trial to Assess the Efficacy and Safety of Topical SR-T100 Gel in the Treatment of Patients With Actinic Keratosis

Completed Phase 3 Last updated 17 February 2016

What this trial tests

Phase 3 trial testing SR-T100 gel in Actinic Keratosis in 113 participants. Completed in 1 November 2015.

Timeline

1 October 2011

Primary endpoint
1 November 2015

1 November 2015

Quick facts

Lead sponsor	G&E Herbal Biotechnology Co., LTD
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	113
Start date	1 October 2011
Primary completion	1 November 2015
Estimated completion	1 November 2015
Sites	6 locations across Taiwan

Drugs / interventions tested

• SR-T100 gel — full drug profile →
• Vehicle gel

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.

• Comparison of SR-T100 gel effect with those of vehicle gel (Placebo) on efficacy and tolerability in patients with actinic keratosis
  Time frame: 24 weeks
  The primary objective is to compare the complete clearance rate between treatment groups at 8 weeks after the completion of 16 weeks study treatment. The primary efficacy endpoint is to evaluate the complete clearance rate at 8 weeks after the completion of 16 weeks study treatment between treatment groups. The complete clearance is defined as the absence of visible or palpable AK lesions in the t

Sponsor's own description

Studies of SR-T100 gel and its clinical relevance in the treatment of AK, providing adequate measured outcomes for skin lesion treatment. In addition to the high complete response rate (90.0%) as compared with the conventional therapy, the most significant result was that no undesirable side effects were associated with the use of SR-T100 gel. The result also shows approximately 80% of study subjects had a complete response in phase II clinical trial conducted in Taiwan; hence, result from our study model suggested SR-T100 gel offers beneficial therapeutic values in treatment of AK is harmless to the skin as well as high tolerance level displayed by majority of patients.

Publications & conference data

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

1. Interventions for actinic keratoses.
   Gupta AK, Paquet M, Villanueva E, Brintnell W. · · 2012 · cited 96× · PMID 23235610 · DOI 10.1002/14651858.cd004415.pub2