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ABSORICA in Patients With Severe Recalcitrant Nodular Acne

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ClinicalTrials.gov Identifier: NCT02457520
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited

Tracking Information
First Submitted Date  ICMJE May 16, 2015
First Posted Date  ICMJE May 29, 2015
Last Update Posted Date November 5, 2018
Actual Study Start Date  ICMJE January 21, 2015
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
Quality of life (QOL) of subjects who are taking Absorica® (isotretinoin) [ Time Frame: 20 weeks ]
Change from Baseline to the end of active treatment period (ATP) at week 20 in the acne-specific quality of life (acne-QOL) questionnaire score for those subjects who complete the 20-week ATP and are at least 75% compliant with the treatment regimen (isotretinoin) capsules twice daily without food for the treatment of severe recalcitrant nodular acne
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02457520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
  • Change from baseline in the lesion count [ Time Frame: 20 weeks ]
    Change from baseline in the lesion count (nodules and inflammatory lesions) at the end of the ATP.
  • Change from baseline in the acne-quality of life (QOL) score [ Time Frame: 20 weeks ]
    Change from baseline in the acne-QOL score
  • Change from baseline in the Investigator's Global Assessment (IGA) [ Time Frame: 20 weeks ]
    Change from baseline in the IGA at the end of the active treatment period in subjects who complete the 20-week active treatment period
  • Treatment safety (adverse events) [ Time Frame: 20 weeks ]
    Treatment safety as determined by the frequency and severity of adverse events
  • Treatment safety (local skin irritation) [ Time Frame: 20 weeks ]
    Treatment safety as determined by local skin irritation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 28, 2015)
  • Primary endpoint for post treatment period (PTP) (Proportion of subjects who require retreatment) [ Time Frame: 104 weeks ]
    Proportion of subjects who require retreatment with oral isotretinoin at any time during post treatment period and the time at which retreatment is required
  • Secondary endpoint for PTP (Proportion of subjects who require treatment with a prescription anti-acne medication) [ Time Frame: 104 weeks ]
    Proportion of subjects who require treatment with a prescription anti-acne medication other than oral isotretinoin at any point during the PTP
  • Secondary endpoint for PTP (Proportion of subjects who use an over-the-counter (OTC) anti-acne medication) [ Time Frame: 104 weeks ]
    Proportion of subjects who use an over-the-counter (OTC) anti-acne medication at any time during the PTP
  • Secondary endpoint for PTP (Severity of acne (lesion count and IGA) [ Time Frame: 104 weeks ]
    Severity of acne (lesion count and IGA) at the time of retreatment in subjects treated with a prescription or OTC anti-acne treatment
  • Secondary endpoint for PTP (Severity of acne (lesion count and IGA) [ Time Frame: 104 weeks ]
    Severity of acne (lesion count and IGA) at each visit
  • Secondary endpoint for PTP (Time to retreatment with a prescription or over-the-counter (OTC) anti-acne medication) [ Time Frame: 104 weeks ]
    Time to retreatment with a prescription or over-the-counter (OTC) anti-acne medication at any time during the PTP
  • Secondary endpoint for PTP (Acne-quality of life) [ Time Frame: 104 weeks ]
    Acne-quality of life at the end of PTP
  • Secondary endpoint for PTP (monitoring of adverse events, laboratory test results, vital signs, and physical examinations) [ Time Frame: 104 weeks ]
    Safety as assessed through the monitoring of adverse events, laboratory test results, vital signs, and physical examinations
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE ABSORICA in Patients With Severe Recalcitrant Nodular Acne
Official Title  ICMJE An Open-label Study Evaluating the Long-term Efficacy, Quality of Life, and Safety of ABSORICA® (Isotretinoin) Capsules Administered Without Food in Patients With Severe Recalcitrant Nodular Acne
Brief Summary

This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.

ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or abstinence are included.

Detailed Description

This study is designed to collect efficacy, safety, and quality of life (QOL) data from subjects who receive Absorica® without food. The study will investigate the treatment efficacy, frequency of relapse once the treatment has been discontinued, quality of life during the active treatment and during a 2-year post treatment period and the overall safety of treatment with Absorica®.

This is a single-arm, open-label study consisting of 2 phases: a 20-week (5-month) open-label Active Treatment Period (ATP) and a 104-week (2-year) post treatment period (PTP). The total study duration is to be 124 weeks, excluding a screening period. During the ATP, after week 2 visit, visits will be scheduled at 4-week intervals for a total of 8 visits (1 screening visit, 1 baseline visit, and 6 on-study visits). During the PTP, the first visit will be 4 weeks after End of Treatment (EOT), the second visit will be 12 weeks after EOT, and subsequent visits will be scheduled at 26-week (± 2 weeks) intervals for a total of 6 visits.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE Drug: Isotretinoin
ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Other Name: ABSORICA
Study Arms  ICMJE Experimental: Single treatment arm
ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.
Intervention: Drug: Isotretinoin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 28, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

General Inclusion Criteria Subjects must meet the following mandatory inclusion criteria at the time of screening to be eligible to enter the study and must agree to conform to the requirements of the study and the iPLEDGE program.

  • Written informed consent, including mandatory photographic consent, on a gender-specific informed consent form (ICF) & Health Insurance Portability and Accountability Act (HIPAA) authorization prior to the performance of any study-related procedures.
  • Pregnant females and females who are not to become pregnant during the ATP phase of the trial and for 30 days after receiving their last dose of study drug.
  • Female subjects of childbearing potential ready to use 2 forms of effective contraception simultaneously for 1 month before starting Absorica® (isotretinoin), while taking Absorica® & for 1 month after Absorica® has been stopped.
  • Male and female subjects of non-childbearing potential

Specific Inclusion Criteria:

  • Severe recalcitrant nodular acne.
  • Five or more nodule lesions on the face.
  • Treatment-naïve subjects.
  • Age between 12 and 45 years.
  • Weight between 40 and 110 kg.
  • Female subjects of childbearing potential only: Negative results from serum pregnancy tests with a sensitivity of at least 25 milli-international unit/mL.
  • Good general health as determined by the investigator based on the subject's medical history, physical examination, vital signs measurements, and laboratory test results.
  • Subjects who present with stable & controlled diabetes mellitus (Types I and II).
  • Subjects with previously diagnosed polycystic ovarian syndrome (PCOS) can be included in the study if in the opinion of the investigator they do not have any other clinically significant abnormality (eg, metabolic syndrome or elevated lipids

Exclusion Criteria:

General Exclusion Criteria

  • Presence of any clinically significant physical examination finding, vital signs measurement, or abnormal laboratory value;
  • Presence of a beard or other facial hair that could interfere with the study assessments;
  • Participated in another clinical trial or received an investigational product within 3 months prior to screening;
  • History of excessive or suspected abuse of alcohol (based on the clinical judgment of the investigator), recreational drugs, and/or drugs of abuse, e.g., club drugs, cocaine, ecstasy/ methylenedioxymethamphetamine, heroin, inhalants, marijuana, methamphetamine, phencyclidine, prescription medications, anabolic steroids, etc.
  • Use of prohibited or restricted prior or concomitant medications. Female Specific Exclusion Criteria
  • Are pregnant;
  • Are at a high risk for becoming pregnant or likely to become pregnant during treatment;
  • Are breast-feeding or considering breast-feeding during the course of the study;
  • Have a known history of PCOS with another clinically significant abnormality (eg, metabolic syndrome or elevated lipids);
  • Are unable or unwilling to maintain compliance with birth control measures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02457520
Other Study ID Numbers  ICMJE ABS157LT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sun Pharmaceutical Industries Limited
Study Sponsor  ICMJE Sun Pharmaceutical Industries Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ashish Anvekar, MD Ranbaxy Laboratories Limited
PRS Account Sun Pharmaceutical Industries Limited
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP