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NCT00635609 · ClinicalTrials.gov registry record · Phase 4

Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

A Phase 4 study, sponsored by Warner Chilcott.

Completed
Registry status
Phase 4
Development phase
93
Enrollment target

NCT00635609: Completed Phase 4 study, sponsored by Warner Chilcott.

NCT00635609 is a Phase 4 study that has completed, run by Warner Chilcott. The registered enrollment target is 93 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00635609, a Phase 4 study, has completed, sponsored by Warner Chilcott.

COMPLETED
Registry status
Phase 4
Development phase
93 participants
Enrollment target

Study Summary

Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.

Primary Outcome

The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.

Interventions

  • DRUG Doxycycline hyclate
  • DRUG Doxycycline hyclate (Doryx)

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2008-03
Est. Completion 2008-09
Phase Phase 4
Warner Chilcott

53 total trials

What the finished NCT00635609 record still lists

NCT00635609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).

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

NCT00635609 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00635609 about?

NCT00635609 is a clinical study titled "Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate". Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.

What is the current status of trial NCT00635609?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 93 participants. The study started on 2008-03. Estimated completion is 2008-09.

What interventions are being tested in trial NCT00635609?

The interventions under investigation include: Doxycycline hyclate (DRUG), Doxycycline hyclate (Doryx) (DRUG).

Who is sponsoring clinical trial NCT00635609?

This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00635609's enrollment target sits among peer trials

93 874th of 2000 higher than 1,125 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00635609, the US trial registry maintained by the National Library of Medicine. NCT00635609 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.