Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne
NCT ID: NCT00975143
Last Updated: 2014-07-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
925 participants
INTERVENTIONAL
2009-09-30
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
NCT00666900
A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris
NCT01631474
Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adults Subjects With Facial Acne.
NCT07341659
Acne Remission Maintenance by Weekend Systemic Isotretinoin
NCT06451237
A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)
NCT02608450
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CIP-Isotretinoin
CIP-Isotretinoin
0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.
Isotretinoin
Isotretinoin
0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CIP-Isotretinoin
0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.
Isotretinoin
0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
12 Years
54 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cipher Pharmaceuticals Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James J. Leyden, MD
Role: STUDY_CHAIR
University of Pennsylvania
Guy Webster, MD
Role: STUDY_CHAIR
Jefferson Medical College of Thomas Jefferson University
Jason A. Gross, PharmD
Role: STUDY_DIRECTOR
Cipher Pharmaceuticals Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Haber Dermatology, Clinical Research Center
South Euclid, Ohio, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Paddington Testing Company Inc.
Philadelphia, Pennsylvania, United States
Radiant Research, Inc.
Greer, South Carolina, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Arlington Center for Dermatology
Arlington, Texas, United States
Suzanne Bruce and Associates - The Center for Skin Research
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Stephen Miller, MD, PA Dermatology
San Antonio, Texas, United States
Dermatology Research Center
Salt Lake City, Utah, United States
Premier Clinical Research
Spokane, Washington, United States
Derm Research @ 888 Inc.
Vancouver, British Columbia, Canada
Dermadvances Research
Winnipeg, Manitoba, Canada
Durondel C.P. Inc
Moncton, New Brunswick, Canada
Newlab Clinical Research Inc.
St. John's, Newfoundland and Labrador, Canada
UltraNova Skincare
Barrie, Ontario, Canada
Dermatrials Research
Hamilton, Ontario, Canada
The Guenther Dermatology Research Centre
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Windsor Clinical Research
Windsor, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISOCT.08.01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.