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

Phase 3
12 Years
54 Years
Not Enrolling
Severe Nodular Acne

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Co-primary outcomes: a) Total nodular lesion count (facial and truncal); and b) Proportion of patients who achieve at least a 90% reduction in total number of nodular lesions (facial and truncal).

Outcome Time Frame:

20 weeks

Safety Issue:


Principal Investigator

James J. Leyden, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pennsylvania


United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

May 2011

Related Keywords:

  • Severe Nodular Acne
  • isotretinoin
  • dermatology
  • skin
  • Acne Vulgaris



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