A Study of A-101 Topical Solution for the Treatment of Common Warts
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03691831|
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Common Wart||Drug: A-101 Other: Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The blinded vehicle solution is packaged to match the active study drug and will be stored under the same conditions.|
|Official Title:||A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts|
|Actual Study Start Date :||September 17, 2018|
|Estimated Primary Completion Date :||February 28, 2019|
|Estimated Study Completion Date :||May 30, 2019|
Active Comparator: A-101
Topical solution, hydrogen peroxide 45%
hydrogen peroxide 45% topical solution
Other Name: hydrogen peroxide 45%
Placebo Comparator: Vehicle
Topical solution, isopropyl alcohol and water
Vehicle solution containing isopropyl alcohol and water
Other Name: isopropyl alcohol and sterile water
- The primary efficacy endpoint is the proportion of subjects whose identified common warts are determined to be clear on the PWA scale (PWA=0) [ Time Frame: Day 60 ]
The primary efficacy endpoint is the proportion of subjects whose identified common warts are determined to be clear on the PWA scale (PWA=0) at Visit 10 (Day 60).
Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale
- Proportion of subjects who achieve complete clearance of all identified common warts (PWA =0). [ Time Frame: Day 137 ]Complete clearance of all identified common warts will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale.
- Comparison between A-101 45% and Vehicle of the mean per subject percent of treated warts that are clear (PWA=0) [ Time Frame: Day 137 ]Clearance of all treated warts will be assessed using the PWA scale which is a four point scale.
- Comparison between A-101 45% and Vehicle of the proportion of subjects with a single wart at baseline, whose wart is clear (PWA=0). [ Time Frame: Day 60 ]Clearance of the single wart at baseline will be assessed using the PWA scale which is a four point scale.
- Comparison between A-101 45% and vehicle with respect to the median time to achieve onset of clearance (PWA=0) for all treated warts. [ Time Frame: Day 137 ]Clearance of all treated warts will be assessed using the PWA scale which is a four point scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691831
|Contact: Ann Marie Hulstineemail@example.com|
Show 24 Study Locations
|Study Director:||Judy Schynder||Aclaris Therapeutics|