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Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne

NCT00975143 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 925

Last updated 2014-07-04

Study results available
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Summary

The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a marketed (generic) formulation of isotretinoin when both are administered twice daily with meals.

Conditions

  • Severe Nodular Acne

Interventions

DRUG

CIP-Isotretinoin

0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.

DRUG

Isotretinoin

0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.

Sponsors & Collaborators

  • Cipher Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • James J. Leyden, MD · University of Pennsylvania

  • Guy Webster, MD · Jefferson Medical College of Thomas Jefferson University

  • Jason A. Gross, PharmD · Cipher Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States
  • Canada

Study Locations

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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 NCT00975143 on ClinicalTrials.gov