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

Information source: Cipher Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Severe Nodular Acne

Intervention: CIP-Isotretinoin (Drug); Isotretinoin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cipher Pharmaceuticals Inc.

Official(s) and/or principal investigator(s):
James J. Leyden, MD, Study Chair, Affiliation: University of Pennsylvania
Guy Webster, MD, Study Chair, Affiliation: Jefferson Medical College of Thomas Jefferson University
Jason A. Gross, PharmD, Study Director, Affiliation: Cipher Pharmaceuticals Inc.


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Co-primary Outcome 1: Change From Baseline in Total Nodular Lesion Count (Facial and Truncal)

Co-Primary Outcome 2: Proportion of Patients Who Achieve at Least a 90% Reduction in Total Number of Nodular Lesions (Facial and Truncal).

Secondary outcome: Proportion of Patients Who Are Rated as Clear/Almost Clear on the Six-point Physicians' Global Assessment Scale (PGSA).


Minimum age: 12 Years. Maximum age: 54 Years. Gender(s): Both.


Inclusion Criteria:

- 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


- 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). Exclusion Criteria:

- 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


- Will be breast-feeding or considering breast feeding during the course of the


- 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.

Locations and Contacts

Total Skin & Beauty Dermatology Center, Birmingham, Alabama 35205, United States

Burke Pharmaceutical Research, Hot Springs, Arkansas 71913, United States

Derm Research @ 888 Inc., Vancouver, British Columbia V5Z 3Y1, Canada

Center for Dermatology Clinical Research, Fremont, California 94538, United States

Dermatology Research Associates, Los Angeles, California 90045, United States

Dermatology Specialists, Oceanside, California 92056, United States

Skin Surgery Medical Group, Inc., San Diego, California 92117, United States

Horizons Clinical Research Center, Denver, Colorado 80220, United States

Ameriderm Research, Jacksonville, Florida 32216, United States

North Florida Dermatology Associates, PA, Jacksonville, Florida 32204, United States

Park Avenue Dermatology, Orange Park, Florida 32073, United States

Ameriderm Research, Ormond Beach, Florida 32174, United States

Peachtree Dermatology Associates, PC, Atlanta, Georgia 30327, United States

MedaPhase Inc., Newnan, Georgia 30263, United States

Northwest Clinical Trials, Boise, Idaho 83704, United States

Northwest Clinical Trials, Nampa, Idaho 83687, United States

Dawes Fretzin Clinical Research, Indianapolis, Indiana 46256, United States

The Indiana Clinical Trials Center, PC, Plainfield, Indiana 46168, United States

The South Bend Clinic, LLP, South Bend, Indiana 46617, United States

Dermatology and Skin Cancer Specialists / Pediaresearch, LLC, Owensboro, Kentucky 42303, United States

Dermadvances Research, Winnipeg, Manitoba R3C 1R4, Canada

ActivMed Practices & Research, Haverhill, Massachusetts 01830, United States

Great Lakes Research Group, Bay City, Michigan 48706, United States

Hamzavi Dermatology, Fort Gratiot, Michigan 48059, United States

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States

Skin Specialists, PC, Omaha, Nebraska 68144, United States

Durondel C.P. Inc, Moncton, New Brunswick E1C 8X3, Canada

Comprehensive Clinical Research, Berlin, New Jersey 08009, United States

Newlab Clinical Research Inc., St. John's, Newfoundland and Labrador A1C 2H5, Canada

Haber Dermatology, Clinical Research Center, South Euclid, Ohio 44118, United States

UltraNova Skincare, Barrie, Ontario L4M 6L2, Canada

Dermatrials Research, Hamilton, Ontario L8N 1V6, Canada

The Guenther Dermatology Research Centre, London, Ontario N6A 3H7, Canada

Lynderm Research Inc., Markham, Ontario L3P 1A8, Canada

North Bay Dermatology Centre, North Bay, Ontario P1B 3Z7, Canada

Institute of Cosmetic and Laser Surgery, Oakville, Ontario L6J 7W5, Canada

K. Papp Clinical Research, Waterloo, Ontario N2J 1C4, Canada

Windsor Clinical Research, Windsor, Ontario N8W 5L7, Canada

Oregon Dermatology and Research Center, Portland, Oregon 97210, United States

Paddington Testing Company Inc., Philadelphia, Pennsylvania 19103, United States

Radiant Research, Inc., Greer, South Carolina 29651, United States

Dermatology Associates of Knoxville, Knoxville, Tennessee 37934, United States

Tennessee Clinical Research Center, Nashville, Tennessee 37215, United States

Arlington Center for Dermatology, Arlington, Texas 76011, United States

Suzanne Bruce and Associates - The Center for Skin Research, Houston, Texas 77056, United States

Progressive Clinical Research, San Antonio, Texas 78229, United States

Stephen Miller, MD, PA Dermatology, San Antonio, Texas 78229, United States

Dermatology Research Center, Salt Lake City, Utah 84117, United States

Premier Clinical Research, Spokane, Washington 99204, United States

Additional Information

Starting date: September 2009
Last updated: June 5, 2014

Page last updated: August 23, 2015

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