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

Completed · Phase 3

Conditions studied: Severe Nodular Acne

In brief

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.

Key facts

Study ID: NCT00975143
Run by: Cipher Pharmaceuticals Inc.
People needed: 925
Starts: 2009-09-01
Expected to finish: 2011-05-01
Last updated by the study team: 2014-07-04

Who can join

Age: 12 and older, up to 54. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Severe recalcitrant nodular acne, which in the opinion of the investigator is compatible with isotretinoin treatment.
Ten (10) or more nodular lesions (facial and/or truncal).
Treatment-naïve patients without any prior exposure to systemic isotretinoin or other retinoids.
Age between 12 and 54 years.
Weight between 40 and 110 kg.
Negative serum human chorionic gonadotropin (hCG) pregnancy test consistent with a non-pregnant state (females only).
No significant disease or clinically significant finding in a physical examination.
No clinically significant abnormal laboratory value.
No clinically significant abnormal vital sign measurement.
Patients presenting with stable and controlled diabetes mellitus (Types I and II) may be included in the study. However, patients should not have had a hospitalization for any diabetes related complications in the last 12 months, and must be on stable medication for the preceding 6 months. To be included in the study, the patients should have Hemoglobin-A1c values ≤ 6.5% at screening and in the test done 3 - 4 months previously.
Patients with previously diagnosed Polycystic Ovarian Syndrome (PCOS) may be included in the study if in the opinion of the investigator they do not have any other clinically significant abnormality (e.g. metabolic syndrome or elevated lipids).

You may not qualify if…

Female patients will be excluded from the study if they:
Are pregnant;
Are at high risk for becoming pregnant or likely to become pregnant during treatment;
Will be breast-feeding or considering breast feeding during the course of the study.
Known history or presence of any clinically significant unstable medical condition(s) which in the opinion of the investigator could pose a risk for the safety of the patient including any previous history of gastrointestinal disease.
Patients with any skin disease or other condition that might interfere with the evaluation of recalcitrant nodular acne.
Patients will be interviewed using the SCID-CT current and lifetime modules for Major Depression, Mania, and Psychosis. Patients with a lifetime history of psychosis will be excluded. Patients with a history of major depressive, manic, hypomanic or mixed episodes will not be excluded unless they have had an episode during the preceding year.
Patients with any past or current psychotic symptoms.
Patients reporting any suicidal behaviour (including attempts, interrupted attempts, aborted attempts, or other preparatory behaviours), within the past year, or serious suicidal ideation in the past year, will be excluded from study participation.
A lifetime history of wishing to be dead, non-specific active suicidal thoughts or active suicidal ideation without intent to act will not result in exclusion.
Known history or suspected carcinoma.
Known history of liver or kidney disorders (hepatic and renal insufficiency).
Known history or current pseudotumor cerebri (benign intracranial hypertension).
Patients with HLA-B27 related disease, rheumatoid arthritis, rickets or other vitamin D depletion disease or phosphate metabolic disease, severe scoliosis > 15 Cobb angle, history of back surgery/injuries, ongoing use of anticonvulsants known to affect bone metabolism and other genetic or acquired rheumatologic and joint diseases.
All pediatric patients with serum 25-hydroxyvitamin D levels < 20 ng/mL.
Patients with hearing disorders who in the opinion of the investigator would not be able to participate in audiometric testing for the study.
Hypersensitivity or idiosyncratic reaction to isotretinoin, Vitamin A and/or any other drug substances with similar activity.
Allergy to soy beans, soy bean oil or any other ingredients in the study medications.
On a special diet within four weeks prior to drug administration (e.g., liquid, protein, raw food diet).
Difficulty consuming two (2) meals a day to sustain weight and health.

Where it is running

Total Skin & Beauty Dermatology Center — Birmingham, Alabama, United States
Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
Center for Dermatology Clinical Research — Fremont, California, United States
Dermatology Research Associates — Los Angeles, California, United States
Dermatology Specialists — Oceanside, California, United States
Skin Surgery Medical Group, Inc. — San Diego, California, United States
Horizons Clinical Research Center — Denver, Colorado, United States
North Florida Dermatology Associates, PA — Jacksonville, Florida, United States
Ameriderm Research — Jacksonville, Florida, United States
Park Avenue Dermatology — Orange Park, Florida, United States
Ameriderm Research — Ormond Beach, Florida, United States
Peachtree Dermatology Associates, PC — Atlanta, Georgia, United States
MedaPhase Inc. — Newnan, Georgia, United States
Northwest Clinical Trials — Boise, Idaho, United States
Northwest Clinical Trials — Nampa, Idaho, United States
Dawes Fretzin Clinical Research — Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
The South Bend Clinic, LLP — South Bend, Indiana, United States
Dermatology and Skin Cancer Specialists / Pediaresearch, LLC — Owensboro, Kentucky, United States
ActivMed Practices & Research — Haverhill, Massachusetts, United States
Great Lakes Research Group — Bay City, Michigan, United States
Hamzavi Dermatology — Fort Gratiot, Michigan, United States
Minnesota Clinical Study Center — Fridley, Minnesota, United States
Skin Specialists, PC — Omaha, Nebraska, United States
Comprehensive Clinical Research — Berlin, New Jersey, United States

Full record on ClinicalTrials.gov

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