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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.
This study is designed to collect efficacy, safety, and quality of life (QOL) data from subjects who receive Absorica® without food. The study will investigate the treatment efficacy, frequency of relapse once the treatment has been discontinued, quality of life during the active treatment and during a 2-year post treatment period and the overall safety of treatment with Absorica®.
This is a single-arm, open-label study consisting of 2 phases: a 20-week (5-month) open-label Active Treatment Period (ATP) and a 104-week (2-year) post treatment period (PTP). The total study duration is to be 124 weeks, excluding a screening period. During the ATP, after week 2 visit, visits will be scheduled at 4-week intervals for a total of 8 visits (1 screening visit, 1 baseline visit, and 6 on-study visits). During the PTP, the first visit will be 4 weeks after End of Treatment (EOT), the second visit will be 12 weeks after EOT, and subsequent visits will be scheduled at 26-week (± 2 weeks) intervals for a total of 6 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single treatment arm | Experimental | ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isotretinoin | Drug | ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 20 |
| 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). | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and at week 20 |
| Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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.
Specific Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ashish Anvekar, MD | Ranbaxy Laboratories Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32038751 | Derived | Del Rosso JQ, Stein Gold L, Segal J, Zaenglein AL. An Open-label, Phase IV Study Evaluating Lidose-isotretinoin Administered without Food in Patients with Severe Recalcitrant Nodular Acne: Low Relapse Rates Observed Over the 104-week Post-treatment Period. J Clin Aesthet Dermatol. 2019 Nov;12(11):13-18. Epub 2019 Nov 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Treatment Arm | Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Active Treatment Phase |
|
| ||||||||||||||||||||||||
| Post-treatment Period |
|
safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Treatment Arm | Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This endpoint was analyzed in the per-protocol population and the number of participants analyzed in the per-protocol population set was 166. | Posted | Mean | Standard Deviation | score | Week 20 |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Treatment Arm | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes Mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials | SPIL | 912266455645 | Clinical.Trials@sparcmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2014 | Dec 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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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. |
| Baseline, at week 4, week 8, week 12, and week16 |
| Active Treatment Period- Investigator's Global Assessment at Week 20 | Investigator's Global Assessment score: 0 = Clear
| week 20 |
| 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 | 20 weeks |
| 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 | 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. | 104 weeks |
| Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin | change from Baseline | 104 weeks |
| 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
| 104 weeks |
| Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin | Change from baseline | 104 weeks |
| 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
| 20 weeks |
| 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 | Change from Baseline-Week 124 | week 124 |
| Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period | Investigator's Global Assessment score: 0 = Clear
| week 124 |
| Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications | Change from Baseline | 20 weeks |
| 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
| 20 weeks |
| Visit 14/Week 124 |
| 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 | Visit 14/Week 124 |
| other |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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). | Per Protocol Population | Posted | Number | number of subjects | 20 weeks |
|
|
|
| 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) | Posted | Mean | Standard Deviation | percentage change in lesion count | Baseline and at week 20 |
|
|
|
| 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. | PP population | Posted | Mean | Standard Deviation | score | Baseline, at week 4, week 8, week 12, and week16 |
|
|
|
| Secondary | Active Treatment Period- Investigator's Global Assessment at Week 20 | Investigator's Global Assessment score: 0 = Clear
| Posted | Mean | Standard Deviation | score | week 20 |
|
|
|
| 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 | per protocol population | Posted | Mean | Standard Deviation | score | 20 weeks |
|
|
|
| Secondary | Active Treatment Period- Change From Baseline in Nodule Count at Week 20 | Posted | Mean | Standard Deviation | percentage change in nodule count | Baseline, and at week20 |
|
|
|
| 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. | PP population | Posted | Count of Participants | Participants | 104 weeks |
|
|
|
| Secondary | Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin | change from Baseline | Per Protocol Population | Posted | Mean | Standard Deviation | percentage change in lesion count | 104 weeks |
|
|
|
| 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
| Per Protocol Population | Posted | Mean | Standard Deviation | score | 104 weeks |
|
|
|
| Secondary | Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin | Change from baseline | (Per Protocol Population) | Posted | Mean | Standard Deviation | percentage change in lesion count | 104 weeks |
|
|
|
| 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
| Per Protocol population | Posted | Mean | Standard Deviation | score | 20 weeks |
|
|
|
| Secondary | Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period | PP Population | Posted | Mean | Standard Deviation | percentage change in lesion count | week 124 |
|
|
|
| Secondary | Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period | Change from Baseline-Week 124 | Per Protocol population | Posted | Mean | Standard Deviation | percentage change in lesion count | week 124 |
|
|
|
| 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
| per protocol population | Posted | Mean | Standard Deviation | score | week 124 |
|
|
|
| Secondary | Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications | Change from Baseline | (Per Protocol Population) | Posted | Mean | Standard Deviation | percentage change in lesion count | 20 weeks |
|
|
|
| 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
| (Per Protocol Population) | Posted | Mean | Standard Deviation | score | 20 weeks |
|
|
|
| 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. | PP Population | Posted | Mean | Standard Deviation | score | Visit 14/Week 124 |
|
|
|
| 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 | per protocol population | Posted | Mean | Standard Deviation | score | Visit 14/Week 124 |
|
|
|
| 0 |
| 201 |
| 1 |
| 201 |
| 54 |
| 201 |
| Lip dry | Gastrointestinal disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
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| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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| Visit 7/Week 16 |
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| Visit 6/Week 12 |
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| Visit 5/Week 8 |
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| Visit 4/Week 4 |
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