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NCT02147353 · ClinicalTrials.gov registry record · NA
Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT02147353: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02147353 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02147353, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study Summary
External Genital Warts (EGW) are the most common sexually transmitted disease associated with more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective method of EGW treatment. However, multiple sessions may be required with reported clearance rates ranging between 27-88%. Sinecatechins 15% ointment is Food and Drug Administration approved for three times daily application in immunocompetent subjects 18 years and older for the treatment of EGW and perianal warts. Treatment of EGW with cryotherapy followed by sinecatechins appears to be logical. Cryotherapy has direct cytodestructive effects with immediate short-term efficacy on treated EGW, while sinecatechins provide field therapy, treating both clinical and sub-clinical lesions. For this study, the investigators used sinecatechins 15% ointment twice daily regimen and anticipated that the synergistic effect with cryotherapy will provide better efficacy that cryotherapy alone. The investigators also anticipated that the sequential therapy with be safe.
Primary Outcome
Subjects with complete clearance, or no longer have HPV infected cells. Complete clearance was defined as zero lesions at the respective time points.
Interventions
- DRUG Sinecatechins 15% Ointment
- DRUG Cryotherapy alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-12 |
| Phase | NA |
What the finished NCT02147353 record still lists
NCT02147353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Sinecatechins 15% Ointment is the first listed.
NCT02147353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02147353 about?
NCT02147353 is a clinical study titled "Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment". External Genital Warts (EGW) are the most common sexually transmitted disease associated with more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective method of EGW treatment. However, multiple sessions may be required with reported clearance rates ranging between 27-88%. Si...
What is the current status of trial NCT02147353?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2011-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT02147353?
The interventions under investigation include: Sinecatechins 15% Ointment (DRUG), Cryotherapy alone (DRUG).
Who is sponsoring clinical trial NCT02147353?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02147353's enrollment target sits among peer trials
42 1436th of 2000 higher than 555 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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