Phase 4
N=201
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
Acne
Bottom Line
View on ClinicalTrials.gov: NCT02457520 ↗Enrolled (actual)
201
Serious AEs
0.5%
Results posted
Apr 2021
Primary outcome: Primary: Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20 — 100.7 score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Isotretinoin (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries Limited
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20 |
100.7 | — |
| PRIMARY Primary Efficacy Endpoint, Post-treatment Period: Subjects Requiring Retreatment During the Post-treatment Period and Time to Retreatment |
7 | — |
| SECONDARY Active Treatment Period- Change From Baseline in Lesion Counts at Week 20 |
-89.14 | — |
| SECONDARY Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16 |
32.7; 26.3; 17.8; 14.5 | — |
| SECONDARY Active Treatment Period- Investigator's Global Assessment at Week 20 |
-3.1 | — |
| SECONDARY Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16 |
10.6; 10.5; 6.5; 11.6; 8.8; 8.7 | — |
| SECONDARY Active Treatment Period- Change From Baseline in Nodule Count at Week 20 |
-96.18 | — |
| SECONDARY Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment |
22; 8; 25 | — |
| SECONDARY Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin |
-20.81; -1.41; -31.53 | — |
| SECONDARY Post-treatment Period- Severity of Acne by Investigator's Global Assessment at Time of Retreatment With Oral Isotretinoin |
3.0 | — |
| SECONDARY Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin |
-66.16; -72.90; -69.83 | — |
| SECONDARY Post-treatment Period- Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Over-the-Counter Medication |
1.8 | — |
| SECONDARY Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period |
-86.85; -80.45; -85.35 | — |
| SECONDARY Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period |
-99.03 | — |
| SECONDARY Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period |
-3.1 | — |
| SECONDARY Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications |
-66.61; -63.70; -67.04 | — |
| SECONDARY Post Treatment Period-Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Prescription Other Than Oral Isotretinoin |
-2.4 | — |
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.
Eligibility Criteria
General Inclusion Criteria Subjects must meet the following mandatory inclusion criteria at the time of screening to be eligible to enter the study and must agree to conform to the requirements of the study and the iPLEDGE program.
- Written informed consent, including mandatory photographic consent, on a gender-specific informed consent form (ICF) & Health Insurance Portability and Accountability Act (HIPAA) authorization prior to the performance of any study-related procedures.
- Pregnant females and females who are not to become pregnant during the ATP phase of the trial and for 30 days after receiving their last dose of study drug.
- Female subjects of childbearing potential ready to use 2 forms of effective contraception simultaneously for 1 month before starting Absorica® (isotretinoin), while taking Absorica® & for 1 month after Absorica® has been stopped.
- Male and female subjects of non-childbearing potential
Specific Inclusion Criteria:
- Severe recalcitrant nodular acne.
- Five or more nodule lesions on the face.
- Treatment-naïve subjects.
- Age between 12 and 45 years.
- Weight between 40 and 110 kg.
- Female subjects of childbearing potential only: Negative results from serum pregnancy tests with a sensitivity of at least 25 milli-international unit/mL.
- Good general health as determined by the investigator based on the subject's medical history, physical examination, vital signs measurements, and laboratory test results.
- Subjects who present with stable & controlled diabetes mellitus (Types I and II).
- Subjects with previously diagnosed polycystic ovarian syndrome (PCOS) can be included in the study if in the opinion of the investigator they do not have any other clinically significant abnormality (eg, metabolic syndrome or elevated lipids
Exclusion Criteria
General Exclusion Criteria
- Presence of any clinically significant physical examination finding, vital signs measurement, or abnormal laboratory value;
- Presence of a beard or other facial hair that could interfere with the study assessments;
- Participated in another clinical trial or received an investigational product within 3 months prior to screening;
- History of excessive or suspected abuse of alcohol (based on the clinical judgment of the investigator), recreational drugs, and/or drugs of abuse, e.g., club drugs, cocaine, ecstasy/ methylenedioxymethamphetamine, heroin, inhalants, marijuana, methamphetamine, phencyclidine, prescription medications, anabolic steroids, etc.
- Use of prohibited or restricted prior or concomitant medications. Female Specific Exclusion Criteria
- Are pregnant;
- Are at a high risk for becoming pregnant or likely to become pregnant during treatment;
- Are breast-feeding or considering breast-feeding during the course of the study;
- Have a known history of PCOS with another clinically significant abnormality (eg, metabolic syndrome or elevated lipids);
- Are unable or unwilling to maintain compliance with birth control measures
Data sourced from ClinicalTrials.gov (NCT02457520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.