ABSORICA in Patients With Severe Recalcitrant Nodular Acne

• Sponsor: Sun Pharmaceutical Industries Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02457520
• Collaborator: (none)
• Enrollment: 201
• Location: 1
• Arm: 1
• Actual Duration (Months): 38.3
• Patients Per Site Per Month: 5.2

Study Details

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.

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.

Study Design

• Study Type: Interventional
• 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: Jan 21, 2015
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Apr 1, 2018

Arms and Interventions

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 Names: ABSORICA

Outcome Measures

Primary Outcome Measures

1. Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20 [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 [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 [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 [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 [week 20]

   Investigator's Global Assessment score: 0 = Clear = Almost Clear = Mild = Moderate = Severe = 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 [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 [Baseline, and at week20]

6. Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment [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 [104 weeks]

   change from Baseline

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

   Investigator's Global Assessment score: 0 = Clear = Almost Clear = Mild = Moderate = Severe = Very Severe

9. Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin [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 [20 weeks]

    Investigator's Global Assessment score: 0 = Clear = Almost Clear = Mild = Moderate = Severe = Very Severe

11. Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period [week 124]

12. Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period [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 [week 124]

    Investigator's Global Assessment score: 0 = Clear = Almost Clear = Mild = Moderate = Severe = Very Severe

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

    Investigator's Global Assessment score: 0 = Clear = Almost Clear = Mild = Moderate = Severe = 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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Dermatology and Laser Specialists	San Antonio	Texas	United States	78218

Sponsors and Collaborators

• Sun Pharmaceutical Industries Limited

Investigators

• Study Director: Ashish Anvekar, MD, Ranbaxy Laboratories Limited

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 19, 2014

More Information

Publications

None provided.

• Responsible Party: Sun Pharmaceutical Industries Limited
• ClinicalTrials.gov Identifier: NCT02457520
• Other Study ID Numbers: ABS157LT
• First Posted: May 29, 2015
• Last Update Posted: Apr 27, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Acne Vulgaris; Isotretinoin

Study Results

Participant Flow

Arm/Group Title	Single Treatment Arm
Arm/Group Description	Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.
Period Title: Active Treatment Phase
STARTED	201
COMPLETED	167
NOT COMPLETED	34
Period Title: Active Treatment Phase
STARTED	167
COMPLETED	119
NOT COMPLETED	48

Baseline Characteristics

Arm/Group Title	Single Treatment Arm
Arm/Group Description	Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.
Overall Participants	201
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	18.7 (6.4)
Sex: Female, Male (Count of Participants)
Female	76 37.8%
Male	125 62.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	31 15.4%
Not Hispanic or Latino	170 84.6%
Unknown or Not Reported	NA NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 1.5%
Asian	8 4%
Native Hawaiian or Other Pacific Islander	1 0.5%
Black or African American	17 8.5%
White	167 83.1%
More than one race	1 0.5%
Unknown or Not Reported	4 2%
Region of Enrollment (participants) [Number]
United States	201 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This endpoint was analyzed in the per-protocol population and the number of participants analyzed in the per-protocol population set was 166.

Arm/Group Title	Single Treatment Arm
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	166
Mean (Standard Deviation) [score]	100.7 (18.1)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol Population

Arm/Group Title	Single Treatment Arm
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	163
Number [number of subjects]	7

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Treatment Arm
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	166
Mean (Standard Deviation) [percentage change in lesion count]	-89.14 (16.36)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

PP population

Arm/Group Title	Single Treatment Arm-Week 16	Single Treatment Arm-Week 12	Single Treatment Arm-Week 8	Single Treatment Arm-Week 4
Arm/Group Description	Visit 7/Week 16 ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Visit 6/Week 12 ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Visit 5/Week 8 ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Visit 4/Week 4 ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	159	163	162	149
Mean (Standard Deviation) [score]	32.7 (28.1)	26.3 (24.6)	17.8 (22.4)	14.5 (19.6)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Treatment Arm
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	166
Mean (Standard Deviation) [score]	-3.1 (1.1)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

per protocol population

Arm/Group Title	Single Treatment Arm-Self Perception	Single Treatment Arm-Role-Emotional	Single Treatment Arm-Role-Social	Single Treatment Arm-Acne Symptoms
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	166	166	166	166
Visit 8/Week 20	10.6 (8.9)	10.5 (8.7)	6.5 (7.1)	11.6 (6.1)
Visit 7/Week 16	8.8 (8.8)	8.7 (8.7)	5.4 (7.1)	9.7 (6.2)
Visit 6/Week 12	7.0 (7.9)	6.9 (7.8)	4.3 (6.0)	8.2 (5.9)
Visit 5/Week 8	4.6 (7.1)	4.5 (7.1)	2.6 (5.3)	6.1 (5.6)
Visit 4/Week 4	3.6 (6.3)	4.0 (6.5)	2.1 (5.2)	4.8 (5.0)

7. Secondary Outcome

Title	Active Treatment Period- Change From Baseline in Nodule Count at Week 20
Time Frame	Baseline, and at week20

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Treatment Arm
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	166
Mean (Standard Deviation) [percentage change in nodule count]	-96.18 (11.42)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

PP population

Arm/Group Title	Single Treatment Arm-Retreat With Prescription Anti-acne Medic	Single Treatment Arm - Retreat With Over-the-counter Anti-acne	Single Treatment Arm- Retreat With Prescription or Over-the-co
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	163	163	163
Count of Participants [Participants]	22 10.9%	8 NaN	25 NaN

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol Population

Arm/Group Title	Single Treatment Arm- Total	Single Treatment Arm -Non-inflammatory	Single Treatment Arm-Inflammatory
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	7	7	7
Mean (Standard Deviation) [percentage change in lesion count]	-20.81 (31.15)	-1.41 (95.81)	-31.53 (19.78)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol Population

Arm/Group Title	Single Treatment Arm
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	7
Mean (Standard Deviation) [score]	3.0 (0.6)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(Per Protocol Population)

Arm/Group Title	Single Treatment Arm-Inflammatory	Single Treatment Arm -Non-inflammatory	Single Treatment Arm- Total
Arm/Group Description	Change from baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Change from baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Change from baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	22	22	22
Mean (Standard Deviation) [percentage change in lesion count]	-66.16 (25.93)	-72.90 (30.52)	-69.83 (22.48)

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol population

Arm/Group Title	Single Treatment Arm
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	8
Mean (Standard Deviation) [score]	1.8 (0.7)

13. Secondary Outcome

Title	Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period
Time Frame	week 124

Outcome Measure Data

Analysis Population Description

PP Population

Arm/Group Title	Single Treatment Arm-Inflammatory	Single Treatment Arm -Non-inflammatory	Single Treatment Arm- Total
Arm/Group Description	Change from Baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Change from Baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Change from Baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	118	118	118
Mean (Standard Deviation) [percentage change in lesion count]	-86.85 (18.89)	-80.45 (37.10)	-85.35 (21.65)

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol population

Arm/Group Title	Single Treatment Arm
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	118
Mean (Standard Deviation) [percentage change in lesion count]	-99.03 (5.13)

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

per protocol population

Arm/Group Title	Single Treatment Arm
Arm/Group Description	ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	118
Mean (Standard Deviation) [score]	-3.1 (1.0)

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(Per Protocol Population)

Arm/Group Title	Single Treatment Arm-Inflammatory	Single Treatment Arm -Non-inflammatory	Single Treatment Arm- Total
Arm/Group Description	Change from Baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Change from Baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Change from Baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	8	8	8
Mean (Standard Deviation) [percentage change in lesion count]	-66.61 (17.26)	-63.70 (38.38)	-67.04 (21.87)

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

(Per Protocol Population)

Arm/Group Title	Single Treatment Arm
Arm/Group Description	Change from Baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	22
Mean (Standard Deviation) [score]	-2.4 (1.0)

18. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

PP Population

Arm/Group Title	Single Treatment Arm- Visit 14/ Week 124
Arm/Group Description	Change from Baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Measure Participants	118
Mean (Standard Deviation) [score]	44.4 (29.3)

19. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

per protocol population

Arm/Group Title	Single Treatment Arm-Self Perception	Single Treatment Arm-Role-Emotional	Single Treatment Arm-Role-Social	Single Treatment Arm-Acne Symptoms
Arm/Group Description	Change from Baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Change from Baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Change from Baseline ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Isotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks	Change from Baseline
Measure Participants	118	118	118	118
Mean (Standard Deviation) [score]	12.5 (8.8)	12.6 (9.1)	7.7 (7.5)	11.5 (6.6)

Adverse Events

Time Frame	Active Treatment Period- 20 weeks Post-treatment Period- 124 weeks
Adverse Event Reporting Description	All safety analyses were carried out using the safety population, which was defined as all subjects who received at least 1 dose of study treatment. Thus, overall results are depicted for all the subjects
Arm/Group Title	Single Treatment Arm
Arm/Group Description	Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks. Study ABS1517LT was a Phase 4, open-label, single-arm study in subjects with severe recalcitrant nodular acne, consisting of 2 phases: a 20-week (5-month) Active Treatment Phase and a 104-week (2-year) Post Treatment Period.
All Cause Mortality
	Single Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/201 (0%)
Serious Adverse Events
	Single Treatment Arm
	Affected / at Risk (%)	# Events
Total	1/201 (0.5%)
Metabolism and nutrition disorders
Diabetes Mellitus	1/201 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Single Treatment Arm
	Affected / at Risk (%)	# Events
Total	54/201 (26.9%)
Gastrointestinal disorders
Lip dry	23/201 (11.4%)	23
Psychiatric disorders
Depression	8/201 (4%)	8
Skin and subcutaneous tissue disorders
Dry skin	23/201 (11.4%)	23

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.