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Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris

NCT01628549 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2019-02-01

Study results available
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Summary

To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

50 mg P005672-HCl

P005672-HCl administered as an oral capsule(s) once daily

DRUG

Placebo

Dose-matched Placebo capsule administered as an oral capsule(s) once daily

DRUG

100 mg P005672-HCl

P005672-HCl administered as an oral capsule(s) once daily

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Almirall, S.A.

    lead INDUSTRY

Principal Investigators

  • Herman Ellman, MD · Warner Chilcott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-11-16
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01628549 on ClinicalTrials.gov