Acne
Conditions
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.
Interventions
DRUGIsotretinoin
ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| Active Treatment Period- Investigator's Global Assessment at Week 20 | week 20 | Investigator's Global Assessment score: 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = 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 | 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 |
| Active Treatment Period- Change From Baseline in Nodule Count at Week 20 | Baseline, and at week20 | — |
| 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. |
| 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 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe |
| Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin | 104 weeks | Change from baseline |
| 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 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe |
| Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period | week 124 | — |
| Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period | week 124 | Change from Baseline-Week 124 |
| 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 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe |
| Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications | 20 weeks | Change from Baseline |
| Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin | 104 weeks | 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 | 20 weeks | Investigator's Global Assessment score: 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Treatment Arm Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks. | 201 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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 | Lost to Follow-up | 23 |
| Post-treatment Period | Other | 3 |
| Post-treatment Period | Other: Retreatment Required | 7 |
| Post-treatment Period | Physician Decision | 1 |
| Post-treatment Period | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | Single Treatment Arm |
|---|---|
| Age, Continuous | 18.7 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 170 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | NA Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 167 Participants |
| Region of Enrollment United States | 201 participants |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 201 |
| other Total, other adverse events | 54 / 201 |
| serious Total, serious adverse events | 1 / 201 |
Outcome results
Primary
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.
Time frame: Week 20
Population: This endpoint was analyzed in the per-protocol population and the number of participants analyzed in the per-protocol population set was 166.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20 | 100.7 score | Standard Deviation 18.1 |
Primary
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).
Time frame: 20 weeks
Population: Per Protocol Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Treatment Arm | Primary Efficacy Endpoint, Post-treatment Period: Subjects Requiring Retreatment During the Post-treatment Period and Time to Retreatment | 7 number of subjects |
Secondary
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
Time frame: 20 weeks
Population: per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Treatment Arm | 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 |
| Single Treatment Arm | 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 |
| Single Treatment Arm | 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 |
| Single Treatment Arm | 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 |
| Single Treatment Arm | 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 |
| Single Treatment Arm-Week 12 | 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 | 6.9 score | Standard Deviation 7.8 |
| Single Treatment Arm-Week 12 | 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 | 4.5 score | Standard Deviation 7.1 |
| Single Treatment Arm-Week 12 | 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 | 4.0 score | Standard Deviation 6.5 |
| Single Treatment Arm-Week 12 | 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 | 8.7 score | Standard Deviation 8.7 |
| Single Treatment Arm-Week 12 | 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 | 10.5 score | Standard Deviation 8.7 |
| Single Treatment Arm-Week 8 | 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 | 4.3 score | Standard Deviation 6 |
| Single Treatment Arm-Week 8 | 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 | 6.5 score | Standard Deviation 7.1 |
| Single Treatment Arm-Week 8 | 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 | 5.4 score | Standard Deviation 7.1 |
| Single Treatment Arm-Week 8 | 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 | 2.6 score | Standard Deviation 5.3 |
| Single Treatment Arm-Week 8 | 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 | 2.1 score | Standard Deviation 5.2 |
| Single Treatment Arm-Week 4 | 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 | 6.1 score | Standard Deviation 5.6 |
| Single Treatment Arm-Week 4 | 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 | 9.7 score | Standard Deviation 6.2 |
| Single Treatment Arm-Week 4 | 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 | 11.6 score | Standard Deviation 6.1 |
| Single Treatment Arm-Week 4 | 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 | 8.2 score | Standard Deviation 5.9 |
| Single Treatment Arm-Week 4 | 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 | 4.8 score | Standard Deviation 5 |
Secondary
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.
Time frame: Baseline, at week 4, week 8, week 12, and week16
Population: PP population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | 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 |
| Single Treatment Arm-Week 12 | Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16 | 26.3 score | Standard Deviation 24.6 |
| Single Treatment Arm-Week 8 | Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16 | 17.8 score | Standard Deviation 22.4 |
| Single Treatment Arm-Week 4 | Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16 | 14.5 score | Standard Deviation 19.6 |
Secondary
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)
Time frame: Baseline and at week 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | Active Treatment Period- Change From Baseline in Lesion Counts at Week 20 | -89.14 percentage change in lesion count | Standard Deviation 16.36 |
Secondary
Active Treatment Period- Change From Baseline in Nodule Count at Week 20
Time frame: Baseline, and at week20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | Active Treatment Period- Change From Baseline in Nodule Count at Week 20 | -96.18 percentage change in nodule count | Standard Deviation 11.42 |
Secondary
Active Treatment Period- Investigator's Global Assessment at Week 20
Investigator's Global Assessment score: 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Time frame: week 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | Active Treatment Period- Investigator's Global Assessment at Week 20 | -3.1 score | Standard Deviation 1.1 |
Secondary
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.
Time frame: 104 weeks
Population: PP population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Treatment Arm | Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment | 22 Participants |
| Single Treatment Arm-Week 12 | Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment | 8 Participants |
| Single Treatment Arm-Week 8 | Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment | 25 Participants |
Secondary
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 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Time frame: 104 weeks
Population: Per Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | 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
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 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Time frame: 20 weeks
Population: Per Protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | 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
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 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Time frame: 20 weeks
Population: (Per Protocol Population)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | 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 |
Secondary
Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period
Time frame: week 124
Population: PP Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | 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 |
| Single Treatment Arm-Week 12 | Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period | -80.45 percentage change in lesion count | Standard Deviation 37.1 |
| Single Treatment Arm-Week 8 | Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period | -85.35 percentage change in lesion count | Standard Deviation 21.65 |
Secondary
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin
change from Baseline
Time frame: 104 weeks
Population: Per Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | 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 |
| Single Treatment Arm-Week 12 | Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin | -1.41 percentage change in lesion count | Standard Deviation 95.81 |
| Single Treatment Arm-Week 8 | Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin | -31.53 percentage change in lesion count | Standard Deviation 19.78 |
Secondary
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications
Change from Baseline
Time frame: 20 weeks
Population: (Per Protocol Population)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | 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 |
| Single Treatment Arm-Week 12 | Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications | -63.70 percentage change in lesion count | Standard Deviation 38.38 |
| Single Treatment Arm-Week 8 | Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications | -67.04 percentage change in lesion count | Standard Deviation 21.87 |
Secondary
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin
Change from baseline
Time frame: 104 weeks
Population: (Per Protocol Population)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | 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 |
| Single Treatment Arm-Week 12 | Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin | -72.90 percentage change in lesion count | Standard Deviation 30.52 |
| Single Treatment Arm-Week 8 | Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin | -69.83 percentage change in lesion count | Standard Deviation 22.48 |
Secondary
Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period
Change from Baseline-Week 124
Time frame: week 124
Population: Per Protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | 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
Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period
Investigator's Global Assessment score: 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Time frame: week 124
Population: per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period | -3.1 score | Standard Deviation 1 |
Other Pre-specified
Post-treatment Period- Acne-Specific Quality of Life by Domain Scores at the End of the Post-treatment Period
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
Population: per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | 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 |
| Single Treatment Arm-Week 12 | Post-treatment Period- Acne-Specific Quality of Life by Domain Scores at the End of the Post-treatment Period | 12.6 score | Standard Deviation 9.1 |
| Single Treatment Arm-Week 8 | Post-treatment Period- Acne-Specific Quality of Life by Domain Scores at the End of the Post-treatment Period | 7.7 score | Standard Deviation 7.5 |
| Single Treatment Arm-Week 4 | Post-treatment Period- Acne-Specific Quality of Life by Domain Scores at the End of the Post-treatment Period | 11.5 score | Standard Deviation 6.6 |
Other Pre-specified
Post Treatment Period- Acne-Specific Quality of Life by Total Scores at the End of the Post-treatment Period
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
Population: PP Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Treatment Arm | 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 |