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ABSORICA in Patients With Severe Recalcitrant Nodular Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02457520
Recruitment Status : Completed
First Posted : May 29, 2015
Results First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited

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.


Condition or disease Intervention/treatment Phase
Acne Drug: Isotretinoin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 21, 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20 [ Time Frame: Week 20 ]

    There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires.

    Calculation of the domain scores was accomplished by summing all item responses within each domain.

    Self-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.


  2. Primary Efficacy Endpoint, Post-treatment Period: Subjects Requiring Retreatment During the Post-treatment Period and Time to Retreatment [ Time Frame: 20 weeks ]
    subjects who were at least 75% compliant with their assigned treatment, had no major protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 weeks of treatment. (Retreated with Oral Isotretinoin Per Protocol Population).


Secondary Outcome Measures :
  1. Active Treatment Period- Change From Baseline in Lesion Counts at Week 20 [ Time Frame: Baseline and at week 20 ]
    Change from baseline in the lesion count (nodules and inflammatory lesions) at the end of the ATP. (Per Protocol Population)

  2. Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16 [ Time Frame: Baseline, at week 4, week 8, week 12, and week16 ]

    There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires.

    Calculation of the domain scores was accomplished by summing all item responses within each domain.

    Self-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.


  3. Active Treatment Period- Investigator's Global Assessment at Week 20 [ Time Frame: week 20 ]

    Investigator's Global Assessment score:

    0 = Clear

    1. = Almost Clear
    2. = Mild
    3. = Moderate
    4. = Severe
    5. = Very Severe

  4. Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16 [ Time Frame: 20 weeks ]

    Acne-Specific Quality of Life, by domain:

    Self Perception: response on 0- to 6-point scale; the range of possible scores is 0 to 30 points.

    Role-social: response on 0- to 6-point scale; the range of possible scores is 0 to 24 points.

    Role-emotional: response on 0- to 6-point scale, exactly the same as those used for the Self Perception and Role-social domains.

    Acne Symptoms:response on 0- to 6-point scale, domain scores range from 0 to 30 points


  5. Active Treatment Period- Change From Baseline in Nodule Count at Week 20 [ Time Frame: Baseline, and at week20 ]
  6. Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment [ Time Frame: 104 weeks ]
    Retreated with Prescription Anti-Acne Medication, n/Na (%); Over-the-Counter Anti-Acne Medication and Prescription or Over-the-Counter Anti-Acne Medication- Per Protocol Population.

  7. Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin [ Time Frame: 104 weeks ]
    change from Baseline

  8. Post-treatment Period- Severity of Acne by Investigator's Global Assessment at Time of Retreatment With Oral Isotretinoin [ Time Frame: 104 weeks ]

    Investigator's Global Assessment score:

    0 = Clear

    1. = Almost Clear
    2. = Mild
    3. = Moderate
    4. = Severe
    5. = Very Severe

  9. Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin [ Time Frame: 104 weeks ]
    Change from baseline

  10. Post-treatment Period- Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Over-the-Counter Medication [ Time Frame: 20 weeks ]

    Investigator's Global Assessment score:

    0 = Clear

    1. = Almost Clear
    2. = Mild
    3. = Moderate
    4. = Severe
    5. = Very Severe

  11. Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period [ Time Frame: week 124 ]
  12. Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period [ Time Frame: week 124 ]
    Change from Baseline-Week 124

  13. Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period [ Time Frame: week 124 ]

    Investigator's Global Assessment score:

    0 = Clear

    1. = Almost Clear
    2. = Mild
    3. = Moderate
    4. = Severe
    5. = Very Severe

  14. Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications [ Time Frame: 20 weeks ]
    Change from Baseline

  15. Post Treatment Period-Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Prescription Other Than Oral Isotretinoin [ Time Frame: 20 weeks ]

    Investigator's Global Assessment score:

    0 = Clear

    1. = Almost Clear
    2. = Mild
    3. = Moderate
    4. = Severe
    5. = Very Severe


Other Outcome Measures:
  1. Post Treatment Period- Acne-Specific Quality of Life by Total Scores at the End of the Post-treatment Period [ Time Frame: Visit 14/Week 124 ]

    There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires.

    Calculation of the domain scores was accomplished by summing all item responses within each domain.

    Self-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.


  2. Post-treatment Period- Acne-Specific Quality of Life by Domain Scores at the End of the Post-treatment Period [ Time Frame: Visit 14/Week 124 ]

    Acne-Specific Quality of Life, total and by domain:

    Self Perception: response on 0- to 6-point scale; the range of possible scores is 0 to 30 points.

    Role-social: response on 0- to 6-point scale; the range of possible scores is 0 to 24 points.

    Role-emotional: response on 0- to 6-point scale, exactly the same as those used for the Self Perception and Role-social domains.

    Acne Symptoms:response on 0- to 6-point scale, domain scores range from 0 to 30 points




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457520


Locations
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United States, Texas
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
Investigators
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Study Director: Ashish Anvekar, MD Ranbaxy Laboratories Limited
  Study Documents (Full-Text)

Documents provided by Sun Pharmaceutical Industries Limited:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT02457520    
Other Study ID Numbers: ABS157LT
First Posted: May 29, 2015    Key Record Dates
Results First Posted: April 27, 2021
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Isotretinoin
Dermatologic Agents