Highlights
- •Current topical treatments to actinic keratosis have substantial side effects.
- •Topical SR-T100 gel yielded 32.4% complete clearance rate and 71.8% partial clearance rate to AK lesions.
- •Topical SR-T100 gel may be a safe and effective treatment modality for field therapy of actinic keratosis.
Abstract
Background
Currently available topical treatments for actinic keratosis (AK) are associated with
substantial side-effects.
Objectives
To evaluate the efficacy and safety of topical SR-T100 gel in treating AK.
Methods
A multicenter, randomized, double-blinded phase III trial was conducted. Patients
with at least two clinically visible AK were enrolled and a punch biopsy was performed
on one of the AK to confirm the diagnosis. This study consisted of up to 16-week treatment
and 8-week post-treatment periods. Medication was applied daily with occlusive dressing.
Results
123 subjects were recruited and 113 were randomized. 76 subjects were in the SR-T100
and 37 in the vehicle arms. In SR-T100 and vehicle groups, 32.39% and 17.14% of subjects
achieved complete clearance, respectively. For 75% partial clearance of lesions, 71.83%
and 37.1% of subjects achieved this goal in SR-T100 and vehicle group, respectively.
When comparing SR-T100 to vehicle, the odds ratio of complete clearance was 2.14 (p = 0.111), and odds ratio of partial clearance was 4.36 (p < 0.001). Severe local reactions were reported by only one subject using SR-T100.
Conclusion
The imitation of the study was that not all the treated AK lesions were confirmed
by histopathology. The diagnostic uncertainty may contribute to the high partial clearance
rate in the vehicle group since the clinical-diagnosed AK showed higher clearance
rate compared to histopathology-confirmed AK. The use of occlusive dressing was another
possible explanation for high placebo effects. The results suggested that topical
SR-T100 gel may be an effective and safe treatment for field therapy of AK.
Keywords
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Article info
Publication history
Published online: February 26, 2018
Accepted:
February 23,
2018
Received in revised form:
February 22,
2018
Received:
November 30,
2017
Identification
Copyright
© 2018 Japanese Society for Investigative Dermatology. Published by Elsevier B.V. All rights reserved.
