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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

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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT00975143. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 15, 2026, 6:39 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. 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
Sep 2009 (Type not available)
Primary completion
May 2011 (Actual)
Completion
May 2011 (Actual)
Last update posted
Jul 4, 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 4, 2014 · Synced Nov 15, 2026

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