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NCT00622440 · ClinicalTrials.gov registry record · Phase 2

Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream

A Phase 2 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 2
Development phase
70
Enrollment target

NCT00622440: Completed Phase 2 study, sponsored by University of California, San Francisco.

NCT00622440 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00622440, a Phase 2 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 2
Development phase
70 participants
Enrollment target

Study Summary

The purpose of this study is to find out if a Chinese herbal cream is effective in treating HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal intraepithelial neoplasia).

Primary Outcome

Response assessed 12 weeks after treatment. Late Clinical Response (LCR): HSIL present at week 48 but none at week 60, with two independent reviews in agreement that HSIL absent at week 60. Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed h

Interventions

  • DRUG Placebo
  • DRUG AIJP (Arnebia Indigo Jade Pearl)

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2008-05-14
Est. Completion 2012-12-12
Phase Phase 2

What the finished NCT00622440 record still lists

NCT00622440 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00622440 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00622440 about?

NCT00622440 is a clinical study titled "Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream". The purpose of this study is to find out if a Chinese herbal cream is effective in treating HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal intraepithelial neoplasia).

What is the current status of trial NCT00622440?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2008-05-14. Estimated completion is 2012-12-12.

What interventions are being tested in trial NCT00622440?

The interventions under investigation include: Placebo (DRUG), AIJP (Arnebia Indigo Jade Pearl) (DRUG).

Who is sponsoring clinical trial NCT00622440?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00622440's enrollment target sits among peer trials

70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00622440, the US trial registry maintained by the National Library of Medicine. NCT00622440 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.