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NCT00612573 · ClinicalTrials.gov registry record · Phase 2

Treatment of Moderate to Severe Facial Acne Vulgaris

A Phase 2 study, sponsored by Warner Chilcott.

Completed
Registry status
Phase 2
Development phase
257
Enrollment target

NCT00612573: Completed Phase 2 study, sponsored by Warner Chilcott.

NCT00612573 is a Phase 2 study that has completed, run by Warner Chilcott. The registered enrollment target is 257 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00612573, a Phase 2 study, has completed, sponsored by Warner Chilcott.

COMPLETED
Registry status
Phase 2
Development phase
257 participants
Enrollment target

Study Summary

Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.

Primary Outcome

IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory \& inflammatory lesions, no more than a few nodular lesions. Low

Interventions

  • DRUG Placebo
  • DRUG Doxycycline 0.6 mg/kg/day
  • DRUG Doxycycline 1.2 mg/kg/day
  • DRUG Doxycycline 2.4 mg/kg/day

Trial Details

FieldValue
Enrollment Target 257 participants
Start Date 2008-02
Est. Completion 2008-12
Phase Phase 2
Warner Chilcott

53 total trials

What the finished NCT00612573 record still lists

NCT00612573 is an interventional study that assigns participants to a tested intervention. The registered 257 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00612573 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00612573 about?

NCT00612573 is a clinical study titled "Treatment of Moderate to Severe Facial Acne Vulgaris". Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patien...

What is the current status of trial NCT00612573?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 257 participants. The study started on 2008-02. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00612573?

The interventions under investigation include: Placebo (DRUG), Doxycycline 0.6 mg/kg/day (DRUG), Doxycycline 1.2 mg/kg/day (DRUG), Doxycycline 2.4 mg/kg/day (DRUG).

Who is sponsoring clinical trial NCT00612573?

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 NCT00612573's enrollment target sits among peer trials

257 214th of 2000 higher than 1,786 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 NCT00612573, the US trial registry maintained by the National Library of Medicine. NCT00612573 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.