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

NCT02322866 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1034

Last updated 2019-02-01

Study results available
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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

Conditions

  • Acne Vulgaris

Interventions

DRUG

Sarecycline

1.5 mg/kg/day taken orally at the same time each day.

DRUG

Placebo

Placebo-matching sarecycline tablets, taken orally at the same time each day.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Almirall, S.A.

    lead INDUSTRY

Principal Investigators

  • David Berk, MD · Allergan, plc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-03
Primary Completion
2017-01-12
Completion
2017-01-12

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02322866 on ClinicalTrials.gov