Trial Outcomes & Findings for ABSORICA in Patients With Severe Recalcitrant Nodular Acne (NCT NCT02457520)
NCT ID: NCT02457520
Last Updated: 2021-04-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
201 participants
Primary outcome timeframe
Week 20
Results posted on
2021-04-27
Participant Flow
Participant milestones
| Measure |
Single Treatment Arm
Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.
|
|---|---|
|
Active Treatment Phase
STARTED
|
201
|
|
Active Treatment Phase
COMPLETED
|
167
|
|
Active Treatment Phase
NOT COMPLETED
|
34
|
|
Post-treatment Period
STARTED
|
167
|
|
Post-treatment Period
COMPLETED
|
119
|
|
Post-treatment Period
NOT COMPLETED
|
48
|
Reasons for withdrawal
| Measure |
Single Treatment Arm
Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.
|
|---|---|
|
Active Treatment Phase
Adverse Event
|
10
|
|
Active Treatment Phase
Lost to Follow-up
|
8
|
|
Active Treatment Phase
Non-compliance with Study Treatment
|
3
|
|
Active Treatment Phase
other
|
4
|
|
Active Treatment Phase
Physician Decision
|
1
|
|
Active Treatment Phase
Protocol Violation
|
1
|
|
Active Treatment Phase
Withdrawal by Subject
|
7
|
|
Post-treatment Period
Other: Retreatment Required
|
7
|
|
Post-treatment Period
Lost to Follow-up
|
23
|
|
Post-treatment Period
Other
|
3
|
|
Post-treatment Period
Physician Decision
|
1
|
|
Post-treatment Period
Withdrawal by Subject
|
14
|
Baseline Characteristics
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
Baseline characteristics by cohort
| Measure |
Single Treatment Arm
n=201 Participants
Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.
|
|---|---|
|
Age, Continuous
|
18.7 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
170 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
167 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
201 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 20Population: This endpoint was analyzed in the per-protocol population and the number of participants analyzed in the per-protocol population set was 166.
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.
Outcome measures
| Measure |
Single Treatment Arm
n=166 Participants
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
|
Single Treatment Arm-Week 12
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
|
Single Treatment Arm-Week 8
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20
|
100.7 score
Standard Deviation 18.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: Per Protocol Population
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).
Outcome measures
| Measure |
Single Treatment Arm
n=163 Participants
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
|
Single Treatment Arm-Week 12
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
|
Single Treatment Arm-Week 8
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Primary Efficacy Endpoint, Post-treatment Period: Subjects Requiring Retreatment During the Post-treatment Period and Time to Retreatment
|
7 number of subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and at week 20Change from baseline in the lesion count (nodules and inflammatory lesions) at the end of the ATP. (Per Protocol Population)
Outcome measures
| Measure |
Single Treatment Arm
n=166 Participants
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
|
Single Treatment Arm-Week 12
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
|
Single Treatment Arm-Week 8
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Active Treatment Period- Change From Baseline in Lesion Counts at Week 20
|
-89.14 percentage change in lesion count
Standard Deviation 16.36
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, at week 4, week 8, week 12, and week16Population: PP population
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.
Outcome measures
| Measure |
Single Treatment Arm
n=159 Participants
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
|
Single Treatment Arm-Week 12
n=163 Participants
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
|
Single Treatment Arm-Week 8
n=162 Participants
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
|
Single Treatment Arm-Week 4
n=149 Participants
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
|
|---|---|---|---|---|
|
Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16
|
32.7 score
Standard Deviation 28.1
|
26.3 score
Standard Deviation 24.6
|
17.8 score
Standard Deviation 22.4
|
14.5 score
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: week 20Investigator's Global Assessment score: 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Outcome measures
| Measure |
Single Treatment Arm
n=166 Participants
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
|
Single Treatment Arm-Week 12
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
|
Single Treatment Arm-Week 8
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Active Treatment Period- Investigator's Global Assessment at Week 20
|
-3.1 score
Standard Deviation 1.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: per protocol population
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
Outcome measures
| Measure |
Single Treatment Arm
n=166 Participants
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
|
Single Treatment Arm-Week 12
n=166 Participants
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
|
Single Treatment Arm-Week 8
n=166 Participants
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
|
Single Treatment Arm-Week 4
n=166 Participants
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
|
|---|---|---|---|---|
|
Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16
Visit 8/Week 20
|
10.6 score
Standard Deviation 8.9
|
10.5 score
Standard Deviation 8.7
|
6.5 score
Standard Deviation 7.1
|
11.6 score
Standard Deviation 6.1
|
|
Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16
Visit 7/Week 16
|
8.8 score
Standard Deviation 8.8
|
8.7 score
Standard Deviation 8.7
|
5.4 score
Standard Deviation 7.1
|
9.7 score
Standard Deviation 6.2
|
|
Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16
Visit 6/Week 12
|
7.0 score
Standard Deviation 7.9
|
6.9 score
Standard Deviation 7.8
|
4.3 score
Standard Deviation 6.0
|
8.2 score
Standard Deviation 5.9
|
|
Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16
Visit 5/Week 8
|
4.6 score
Standard Deviation 7.1
|
4.5 score
Standard Deviation 7.1
|
2.6 score
Standard Deviation 5.3
|
6.1 score
Standard Deviation 5.6
|
|
Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16
Visit 4/Week 4
|
3.6 score
Standard Deviation 6.3
|
4.0 score
Standard Deviation 6.5
|
2.1 score
Standard Deviation 5.2
|
4.8 score
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Baseline, and at week20Outcome measures
| Measure |
Single Treatment Arm
n=166 Participants
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
|
Single Treatment Arm-Week 12
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
|
Single Treatment Arm-Week 8
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Active Treatment Period- Change From Baseline in Nodule Count at Week 20
|
-96.18 percentage change in nodule count
Standard Deviation 11.42
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: PP population
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.
Outcome measures
| Measure |
Single Treatment Arm
n=163 Participants
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
|
Single Treatment Arm-Week 12
n=163 Participants
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
|
Single Treatment Arm-Week 8
n=163 Participants
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment
|
22 Participants
|
8 Participants
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Per Protocol Population
change from Baseline
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
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
|
Single Treatment Arm-Week 12
n=7 Participants
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
|
Single Treatment Arm-Week 8
n=7 Participants
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin
|
-20.81 percentage change in lesion count
Standard Deviation 31.15
|
-1.41 percentage change in lesion count
Standard Deviation 95.81
|
-31.53 percentage change in lesion count
Standard Deviation 19.78
|
—
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Per Protocol Population
Investigator's Global Assessment score: 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Outcome measures
| Measure |
Single Treatment Arm
n=7 Participants
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
|
Single Treatment Arm-Week 12
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
|
Single Treatment Arm-Week 8
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Post-treatment Period- Severity of Acne by Investigator's Global Assessment at Time of Retreatment With Oral Isotretinoin
|
3.0 score
Standard Deviation 0.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: (Per Protocol Population)
Change from baseline
Outcome measures
| Measure |
Single Treatment Arm
n=22 Participants
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
|
Single Treatment Arm-Week 12
n=22 Participants
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
|
Single Treatment Arm-Week 8
n=22 Participants
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin
|
-66.16 percentage change in lesion count
Standard Deviation 25.93
|
-72.90 percentage change in lesion count
Standard Deviation 30.52
|
-69.83 percentage change in lesion count
Standard Deviation 22.48
|
—
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Per Protocol population
Investigator's Global Assessment score: 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
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
|
Single Treatment Arm-Week 12
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
|
Single Treatment Arm-Week 8
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Post-treatment Period- Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Over-the-Counter Medication
|
1.8 score
Standard Deviation 0.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: week 124Population: PP Population
Outcome measures
| Measure |
Single Treatment Arm
n=118 Participants
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
|
Single Treatment Arm-Week 12
n=118 Participants
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
|
Single Treatment Arm-Week 8
n=118 Participants
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period
|
-86.85 percentage change in lesion count
Standard Deviation 18.89
|
-80.45 percentage change in lesion count
Standard Deviation 37.10
|
-85.35 percentage change in lesion count
Standard Deviation 21.65
|
—
|
SECONDARY outcome
Timeframe: week 124Population: Per Protocol population
Change from Baseline-Week 124
Outcome measures
| Measure |
Single Treatment Arm
n=118 Participants
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
|
Single Treatment Arm-Week 12
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
|
Single Treatment Arm-Week 8
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period
|
-99.03 percentage change in lesion count
Standard Deviation 5.13
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: week 124Population: per protocol population
Investigator's Global Assessment score: 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Outcome measures
| Measure |
Single Treatment Arm
n=118 Participants
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
|
Single Treatment Arm-Week 12
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
|
Single Treatment Arm-Week 8
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period
|
-3.1 score
Standard Deviation 1.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: (Per Protocol Population)
Change from Baseline
Outcome measures
| Measure |
Single Treatment Arm
n=8 Participants
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
|
Single Treatment Arm-Week 12
n=8 Participants
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
|
Single Treatment Arm-Week 8
n=8 Participants
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications
|
-66.61 percentage change in lesion count
Standard Deviation 17.26
|
-63.70 percentage change in lesion count
Standard Deviation 38.38
|
-67.04 percentage change in lesion count
Standard Deviation 21.87
|
—
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: (Per Protocol Population)
Investigator's Global Assessment score: 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Outcome measures
| Measure |
Single Treatment Arm
n=22 Participants
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
|
Single Treatment Arm-Week 12
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
|
Single Treatment Arm-Week 8
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Post Treatment Period-Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Prescription Other Than Oral Isotretinoin
|
-2.4 score
Standard Deviation 1.0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 14/Week 124Population: PP Population
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.
Outcome measures
| Measure |
Single Treatment Arm
n=118 Participants
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
|
Single Treatment Arm-Week 12
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
|
Single Treatment Arm-Week 8
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
|
Single Treatment Arm-Week 4
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
|
|---|---|---|---|---|
|
Post Treatment Period- Acne-Specific Quality of Life by Total Scores at the End of the Post-treatment Period
|
44.4 score
Standard Deviation 29.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 14/Week 124Population: per protocol population
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
Outcome measures
| Measure |
Single Treatment Arm
n=118 Participants
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
|
Single Treatment Arm-Week 12
n=118 Participants
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
|
Single Treatment Arm-Week 8
n=118 Participants
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
|
Single Treatment Arm-Week 4
n=118 Participants
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
|
|---|---|---|---|---|
|
Post-treatment Period- Acne-Specific Quality of Life by Domain Scores at the End of the Post-treatment Period
|
12.5 score
Standard Deviation 8.8
|
12.6 score
Standard Deviation 9.1
|
7.7 score
Standard Deviation 7.5
|
11.5 score
Standard Deviation 6.6
|
Adverse Events
Single Treatment Arm
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Treatment Arm
n=201 participants at risk
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.
|
|---|---|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.50%
1/201 • Number of events 1 • Active Treatment Period- 20 weeks Post-treatment Period- 124 weeks
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
|
Other adverse events
| Measure |
Single Treatment Arm
n=201 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.4%
23/201 • Number of events 23 • Active Treatment Period- 20 weeks Post-treatment Period- 124 weeks
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
|
|
Gastrointestinal disorders
Lip dry
|
11.4%
23/201 • Number of events 23 • Active Treatment Period- 20 weeks Post-treatment Period- 124 weeks
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
|
|
Psychiatric disorders
Depression
|
4.0%
8/201 • Number of events 8 • Active Treatment Period- 20 weeks Post-treatment Period- 124 weeks
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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER