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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00975143

Public ClinicalTrials.gov record NCT00975143. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 20, 2026, 11:59 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-Blind, Randomized, Phase III, Parallel Group Study Evaluating the Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00975143
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Cipher Pharmaceuticals Inc.
Industry
Enrollment
925 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years to 54 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2009
Primary completion
Apr 30, 2011
Completion
Apr 30, 2011
Last update posted
Jul 3, 2014

2009 – 2011

United States locations

U.S. sites
37
U.S. states
22
U.S. cities
35
Facility City State ZIP Site status
Total Skin & Beauty Dermatology Center Birmingham Alabama 35205
Burke Pharmaceutical Research Hot Springs Arkansas 71913
Center for Dermatology Clinical Research Fremont California 94538
Dermatology Research Associates Los Angeles California 90045
Dermatology Specialists Oceanside California 92056
Skin Surgery Medical Group, Inc. San Diego California 92117
Horizons Clinical Research Center Denver Colorado 80220
North Florida Dermatology Associates, PA Jacksonville Florida 32204
Ameriderm Research Jacksonville Florida 32216
Park Avenue Dermatology Orange Park Florida 32073
Ameriderm Research Ormond Beach Florida 32174
Peachtree Dermatology Associates, PC Atlanta Georgia 30327
MedaPhase Inc. Newnan Georgia 30263
Northwest Clinical Trials Boise Idaho 83704
Northwest Clinical Trials Nampa Idaho 83687
Dawes Fretzin Clinical Research Indianapolis Indiana 46256
The Indiana Clinical Trials Center, PC Plainfield Indiana 46168
The South Bend Clinic, LLP South Bend Indiana 46617
Dermatology and Skin Cancer Specialists / Pediaresearch, LLC Owensboro Kentucky 42303
ActivMed Practices & Research Haverhill Massachusetts 01830
Great Lakes Research Group Bay City Michigan 48706
Hamzavi Dermatology Fort Gratiot Michigan 48059
Minnesota Clinical Study Center Fridley Minnesota 55432
Skin Specialists, PC Omaha Nebraska 68144
Comprehensive Clinical Research Berlin New Jersey 08009
Haber Dermatology, Clinical Research Center South Euclid Ohio 44118
Oregon Dermatology and Research Center Portland Oregon 97210
Paddington Testing Company Inc. Philadelphia Pennsylvania 19103
Radiant Research, Inc. Greer South Carolina 29651
Dermatology Associates of Knoxville Knoxville Tennessee 37934
Tennessee Clinical Research Center Nashville Tennessee 37215
Arlington Center for Dermatology Arlington Texas 76011
Suzanne Bruce and Associates - The Center for Skin Research Houston Texas 77056
Progressive Clinical Research San Antonio Texas 78229
Stephen Miller, MD, PA Dermatology San Antonio Texas 78229
Dermatology Research Center Salt Lake City Utah 84117
Premier Clinical Research Spokane Washington 99204

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00975143, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 3, 2014 · Synced Sep 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00975143 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →