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NCT02322866 · ClinicalTrials.gov registry record · Phase 3

Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

A Phase 3 study of Acne Vulgaris, sponsored by Almirall, S.A..

Completed
Registry status
Phase 3
Development phase
1,034
Enrollment target
20
Study locations

NCT02322866: Completed Phase 3 study of Acne Vulgaris, sponsored by Almirall, S.A..

NCT02322866 is a Phase 3 study of Acne Vulgaris that has completed, run by Almirall, S.A.. The registered enrollment target is 1,034 participants, above the 260-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (298% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02322866, a Phase 3 study of Acne Vulgaris, has completed, sponsored by Almirall, S.A..

COMPLETED
Registry status
Phase 3
Development phase
1,034 participants
Enrollment target
20
Study locations

Study Summary

To evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris

Primary Outcome

Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \< 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \> 0.5 cm in

Conditions Studied

Acne Vulgaris

Interventions

  • DRUG Placebo
  • DRUG Sarecycline

Study Locations (20)

Florida

  • Warner Chilcott Research Site (Site #237) - Aventura
  • Warner Chilcott Research Site (Site #226) - Clearwater
  • Warner Chilcott Research Site (Site #238) - Jupiter
  • Warner Chilcott Research Site (Site #255) - Lauderdale Lakes
  • Warner Chilcott Research Site (Site #249) - Miami
  • Warner Chilcott Research Site (Site #202) - Miami
  • Warner Chilcott Research Site (Site #211) - Miramar
  • Warner Chilcott Research Site (Site #247) - Ocala
  • Warner Chilcott Research Site (Site #241) - Orlando

California

  • Warner Chilcott Research Site (Site #245) - Carlsbad
  • Warner Chilcott Research Site (Site #234) - Encinitas
  • Warner Chilcott Research Site (Site #209) - Fremont
  • Warner Chilcott Research Site (Site #215) - Oceanside
  • Warner Chilcott Research Site (Site #204) - San Diego
  • Warner Chilcott Research Site (Site #254) - San Diego
  • Warner Chilcott Research Site (Site #257) - Santa Ana
  • Warner Chilcott Research Site (Site #243) - Santa Monica

Alabama

  • Warner Chilcott Research Site (Site #206) - Mobile

Arkansas

  • Warner Chilcott Research Site (Site #236) - Hot Springs

Colorado

  • Warner Chilcott Research Site (Site #222) - Denver

Trial Details

FieldValue
Enrollment Target 1,034 participants
Start Date 2014-12-03
Est. Completion 2017-01-12
Phase Phase 3
Almirall, S.A.

19 total trials

What the finished NCT02322866 record still lists

NCT02322866 is an interventional study that assigns participants to a tested intervention. Its 1,034 participants enrollment target places it among the larger protocols in the corpus, above the 260-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (298% higher).

The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02322866 names 20 study sites across 5 states, led by Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT02322866 about?

NCT02322866 is a clinical study titled "Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne". To evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris

What is the current status of trial NCT02322866?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,034 participants. The study started on 2014-12-03. Estimated completion is 2017-01-12.

What conditions does trial NCT02322866 study?

This clinical trial studies the following conditions: Acne Vulgaris.

What interventions are being tested in trial NCT02322866?

The interventions under investigation include: Placebo (DRUG), Sarecycline (DRUG).

Who is sponsoring clinical trial NCT02322866?

This trial is sponsored by Almirall, S.A., which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02322866 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Acne Vulgaris

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02322866's enrollment target sits among peer trials

1,034 1st of 67 higher than 67 of 67 other Acne Vulgaris trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acne Vulgaris 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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Related registry views

Source: ClinicalTrials.gov NCT02322866, the US trial registry maintained by the National Library of Medicine. NCT02322866 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.