Back to resultsABSORICA in Patients With Severe Recalcitrant Nodular Acne
Primary Purpose
Acne
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Isotretinoin
Sponsored by
About this trial
This is an interventional treatment trial for Acne
Eligibility 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
Sites / Locations
- Texas Dermatology and Laser Specialists
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single treatment arm
Arm Description
ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.
Outcomes
Primary Outcome Measures
Active Treatment Period: Total Acne-Specific Quality of Life Score at 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.
Primary Efficacy Endpoint, Post-treatment Period: Subjects Requiring Retreatment During the Post-treatment Period and Time to Retreatment
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
Active Treatment Period- Change From Baseline in Lesion Counts at Week 20
Change from baseline in the lesion count (nodules and inflammatory lesions) at the end of the ATP. (Per Protocol Population)
Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16
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.
Active Treatment Period- Investigator's Global Assessment at Week 20
Investigator's Global Assessment score:
0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
= Very Severe
Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16
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
Active Treatment Period- Change From Baseline in Nodule Count at Week 20
Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment
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.
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin
change from Baseline
Post-treatment Period- Severity of Acne by Investigator's Global Assessment at Time of Retreatment With Oral Isotretinoin
Investigator's Global Assessment score:
0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
= Very Severe
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin
Change from baseline
Post-treatment Period- Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Over-the-Counter Medication
Investigator's Global Assessment score:
0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
= Very Severe
Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period
Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period
Change from Baseline-Week 124
Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period
Investigator's Global Assessment score:
0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
= Very Severe
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications
Change from Baseline
Post Treatment Period-Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Prescription Other Than Oral Isotretinoin
Investigator's Global Assessment score:
0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
= Very Severe
Full Information
NCT ID
NCT02457520
First Posted
May 16, 2015
Last Updated
April 26, 2021
Sponsor
Sun Pharmaceutical Industries Limited
1. Study Identification
Unique Protocol Identification Number
NCT02457520
Brief Title
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 21, 2015 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single treatment arm
Arm Type
Experimental
Arm Description
ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Isotretinoin
Other Intervention Name(s)
ABSORICA
Intervention Description
ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Primary Outcome Measure Information:
Title
Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20
Description
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.
Time Frame
Week 20
Title
Primary Efficacy Endpoint, Post-treatment Period: Subjects Requiring Retreatment During the Post-treatment Period and Time to Retreatment
Description
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).
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Active Treatment Period- Change From Baseline in Lesion Counts at Week 20
Description
Change from baseline in the lesion count (nodules and inflammatory lesions) at the end of the ATP. (Per Protocol Population)
Time Frame
Baseline and at week 20
Title
Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16
Description
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.
Time Frame
Baseline, at week 4, week 8, week 12, and week16
Title
Active Treatment Period- Investigator's Global Assessment at Week 20
Description
Investigator's Global Assessment score:
0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
= Very Severe
Time Frame
week 20
Title
Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16
Description
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
Time Frame
20 weeks
Title
Active Treatment Period- Change From Baseline in Nodule Count at Week 20
Time Frame
Baseline, and at week20
Title
Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment
Description
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.
Time Frame
104 weeks
Title
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin
Description
change from Baseline
Time Frame
104 weeks
Title
Post-treatment Period- Severity of Acne by Investigator's Global Assessment at Time of Retreatment With Oral Isotretinoin
Description
Investigator's Global Assessment score:
0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
= Very Severe
Time Frame
104 weeks
Title
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin
Description
Change from baseline
Time Frame
104 weeks
Title
Post-treatment Period- Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Over-the-Counter Medication
Description
Investigator's Global Assessment score:
0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
= Very Severe
Time Frame
20 weeks
Title
Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period
Time Frame
week 124
Title
Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period
Description
Change from Baseline-Week 124
Time Frame
week 124
Title
Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period
Description
Investigator's Global Assessment score:
0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
= Very Severe
Time Frame
week 124
Title
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications
Description
Change from Baseline
Time Frame
20 weeks
Title
Post Treatment Period-Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Prescription Other Than Oral Isotretinoin
Description
Investigator's Global Assessment score:
0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
= Very Severe
Time Frame
20 weeks
Other Pre-specified Outcome Measures:
Title
Post Treatment Period- Acne-Specific Quality of Life by Total Scores at the End of the Post-treatment Period
Description
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.
Time Frame
Visit 14/Week 124
Title
Post-treatment Period- Acne-Specific Quality of Life by Domain Scores at the End of the Post-treatment Period
Description
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
Time Frame
Visit 14/Week 124
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashish Anvekar, MD
Organizational Affiliation
Ranbaxy Laboratories Limited
Official's Role
Study Director
Facility Information:
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32038751
Citation
Del Rosso JQ, Stein Gold L, Segal J, Zaenglein AL. An Open-label, Phase IV Study Evaluating Lidose-isotretinoin Administered without Food in Patients with Severe Recalcitrant Nodular Acne: Low Relapse Rates Observed Over the 104-week Post-treatment Period. J Clin Aesthet Dermatol. 2019 Nov;12(11):13-18. Epub 2019 Nov 1.
Results Reference
derived
Learn more about this trial
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
We'll reach out to this number within 24 hrs