Efficacy and safety of topical SR-T100 gel in treating actinic keratosis in Taiwan: A Phase III randomized double-blind vehicle-controlled parallel trial

Chao Chun Yang, Tak Wah Wong, Chih Hung Lee, Chien Hui Hong, Chung Hsing Chang, Feng Jie Lai, Shang Hung Lin, Ching Chi Chi, Tzu Kai Lin, Hsi Yen, Chin Han Wu, Hamm Ming Sheu, Cheng Che E. Lan

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 languageEnglish
Pages (from-to)295-302
Number of pages8
JournalJournal of Dermatological Science
Volume90
Issue number3
DOIs
Publication statusPublished - 2018 Jun

Fingerprint

Actinic Keratosis
Taiwan
Gels
Safety
Occlusive Dressings
Odds Ratio
Biopsy
Therapeutics
Placebo Effect
SR-T100
Uncertainty

All Science Journal Classification (ASJC) codes

  • Biochemistry
  • Molecular Biology
  • Dermatology

Cite this

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. / Efficacy and safety of topical SR-T100 gel in treating actinic keratosis in Taiwan : A Phase III randomized double-blind vehicle-controlled parallel trial. In: Journal of Dermatological Science. 2018 ; Vol. 90, No. 3. pp. 295-302.
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title = "Efficacy and safety of topical SR-T100 gel in treating actinic keratosis in Taiwan: A Phase III randomized double-blind vehicle-controlled parallel trial",
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.",
author = "Yang, {Chao Chun} and Wong, {Tak Wah} and Lee, {Chih Hung} and Hong, {Chien Hui} and Chang, {Chung Hsing} and Lai, {Feng Jie} and Lin, {Shang Hung} and Chi, {Ching Chi} and Lin, {Tzu Kai} and Hsi Yen and Wu, {Chin Han} and Sheu, {Hamm Ming} and Lan, {Cheng Che E.}",
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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 journalArticle

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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EP - 302

JO - Journal of Dermatological Science

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