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.
| Original language | English |
|---|---|
| Pages (from-to) | 295-302 |
| Number of pages | 8 |
| Journal | Journal of Dermatological Science |
| Volume | 90 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 2018 Jun |
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All Science Journal Classification (ASJC) codes
- Biochemistry
- Molecular Biology
- Dermatology
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Efficacy and safety of topical SR-T100 gel in treating actinic keratosis in Taiwan : A Phase III randomized double-blind vehicle-controlled parallel trial. / Yang, Chao Chun; Wong, Tak Wah; Lee, Chih Hung; Hong, Chien Hui; Chang, Chung Hsing; Lai, Feng Jie; Lin, Shang Hung; Chi, Ching Chi; Lin, Tzu Kai; Yen, Hsi; Wu, Chin Han; Sheu, Hamm Ming; Lan, Cheng Che E.
In: Journal of Dermatological Science, Vol. 90, No. 3, 06.2018, p. 295-302.Research output: Contribution to journal › Article
TY - JOUR
T1 - Efficacy and safety of topical SR-T100 gel in treating actinic keratosis in Taiwan
T2 - A Phase III randomized double-blind vehicle-controlled parallel trial
AU - Yang, Chao Chun
AU - Wong, Tak Wah
AU - Lee, Chih Hung
AU - Hong, Chien Hui
AU - Chang, Chung Hsing
AU - Lai, Feng Jie
AU - Lin, Shang Hung
AU - Chi, Ching Chi
AU - Lin, Tzu Kai
AU - Yen, Hsi
AU - Wu, Chin Han
AU - Sheu, Hamm Ming
AU - Lan, Cheng Che E.
PY - 2018/6
Y1 - 2018/6
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jdermsci.2018.02.015
DO - 10.1016/j.jdermsci.2018.02.015
M3 - Article
C2 - 29530340
AN - SCOPUS:85043337834
VL - 90
SP - 295
EP - 302
JO - Journal of Dermatological Science
JF - Journal of Dermatological Science
SN - 0923-1811
IS - 3
ER -