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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cipher Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00975143
First received: September 9, 2009
Last updated: June 5, 2014
Last verified: June 2014
Results First Received: July 4, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Severe Nodular Acne
Interventions: Drug: CIP-Isotretinoin
Drug: Isotretinoin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was performed at 49 investigational centers in the United States and Canada. Of the 1265 patients screened for the study, a total of 925 were randomized to CIP-Isotretinoin (N=464) or generic Isotretinoin (N=461) between October 2009 and October 2010. Randomization was stratified by gender and study site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Reasons for screen failure: patient‘s decision (83 pts), low disease severity (61), entry criteria (51), psychological disqualification (44), lost to follow-up (33) and low vitamin D levels (33). Washouts were specified for: systemic corticosteroids, spironolactone (30 d), other acne treatment, phenytoin (14 d), topical corticosteroids (7 d).

Reporting Groups
  Description
CIP-Isotretinoin CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
Isotretinoin (Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks

Participant Flow:   Overall Study
    CIP-Isotretinoin   Isotretinoin
STARTED   464   461 
Completed Treatment (Week 20)   403   410 
COMPLETED   394   401 
NOT COMPLETED   70   60 
Adverse Event                19                15 
Withdrawal by Subject                15                15 
Lost to Follow-up                20                16 
Non-compliance                5                8 
Physician Decision                1                2 
Details not available                10                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CIP-Isotretinoin CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
Isotretinoin (Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
Total Total of all reporting groups

Baseline Measures
   CIP-Isotretinoin   Isotretinoin   Total 
Overall Participants Analyzed 
[Units: Participants]
 464   461   925 
Age 
[Units: Participants]
     
<=18 years   205   192   397 
Between 18 and 65 years   259   269   528 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.8  (7.5)   20.7  (6.8)   20.8  (7.2) 
Gender 
[Units: Participants]
     
Female   187   178   365 
Male   277   283   560 
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
     
Hispanic or Latino   59   63   122 
Not Hispanic or Latino   405   398   803 
Unknown or Not Reported   0   0   0 
[1] Ethnicity was designated as Hispanic or Non-Hispanic.
Region of Enrollment 
[Units: Participants]
     
United States   380   373   753 
Canada   84   88   172 
Nodular Lesion Count [1] 
[Units: Lesions]
Mean (Standard Deviation)
 18.4  (14.7)   17.7  (10.8)   18.0  (12.9) 
[1] Qualified medical practitioners, blinded to treatment group assignment made counts of nodules in the facial and truncal area. Where possible, the same individual performed all evaluations for a patient.
Inflammatory Lesion Count [1] 
[Units: Lesions]
Mean (Standard Deviation)
 37.8  (31.3)   38.4  (34.5)   38.1  (33.0) 
[1] Qualified medical practitioners, blinded to treatment group assignment made counts of inflammatory lesions (papules and pustules) in the facial and truncal area. Where possible, the same individual performed all evaluations for a patient.
Physician's Global Severity Assessment (PGSA) [1] 
[Units: Participants]
     
1 (Almost clear)   3   2   5 
2 (Mild)   11   10   21 
3 (Moderate)   49   60   109 
4 (Severe)   329   322   651 
5 (Very Severe)   64   63   127 
Not assessed   8   4   12 
[1] Acne severity status was graded by the investigator on a 6-point scale, from 0 = Clear (No nodules, pustules or papules visible) to 5 = Very Severe (Highly inflammatory acne covering the affected area, with many nodules and cysts present ). The PGSA was applied to facial lesions only (ie, not conducted on patients with only truncal lesions).


  Outcome Measures
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1.  Primary:   Co-primary Outcome 1: Change From Baseline in Total Nodular Lesion Count (Facial and Truncal)   [ Time Frame: 20 weeks ]

2.  Primary:   Co-Primary Outcome 2: Proportion of Patients Who Achieve at Least a 90% Reduction in Total Number of Nodular Lesions (Facial and Truncal).   [ Time Frame: 20 weeks ]

3.  Secondary:   Proportion of Patients Who Are Rated as Clear/Almost Clear on the Six-point Physicians' Global Assessment Scale (PGSA).   [ Time Frame: 20 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Generic isotretinoin control because Accutane® was discontinued in the US. 201 PPP exclusions (CIP-Isotretinoin 101, Isotretinoin 100) due to discontinuation < Week 20 (61+51), non-compliance with treatment (76+75) or other requirements (≥1 reason).


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Julia Chan, RAC
Organization: Cipher Pharmaceuticals Inc.
phone: 905-602-5840 ext 326
e-mail: jchan@cipherpharma.com



Responsible Party: Cipher Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00975143     History of Changes
Other Study ID Numbers: ISOCT.08.01
Study First Received: September 9, 2009
Results First Received: July 4, 2012
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration