Clinical trial NCT02457520: ABSORICA in Patients With Severe Recalcitrant Nodular Acne
Official title: An Open-label Study Evaluating the Long-term Efficacy, Quality of Life, and Safety of ABSORICA® (Isotretinoin) Capsules Administered Without Food in Patients With Severe Recalcitrant Nodular Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2015-05-29
Enrollment: 201
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20
timeFrame: Week 20
measure: Primary Efficacy Endpoint, Post-treatment Period: Subjects Requiring Retreatment During the Post-treatment Period and Time to Retreatment
timeFrame: 20 weeks
Secondary outcomes:
measure: Active Treatment Period- Change From Baseline in Lesion Counts at Week 20
timeFrame: Baseline and at week 20
measure: Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16
timeFrame: Baseline, at week 4, week 8, week 12, and week16
measure: Active Treatment Period- Investigator's Global Assessment at Week 20
timeFrame: week 20
measure: Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16
timeFrame: 20 weeks
measure: Active Treatment Period- Change From Baseline in Nodule Count at Week 20
timeFrame: Baseline, and at week20
measure: Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment
timeFrame: 104 weeks
measure: Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin
timeFrame: 104 weeks
measure: Post-treatment Period- Severity of Acne by Investigator's Global Assessment at Time of Retreatment With Oral Isotretinoin
timeFrame: 104 weeks
measure: Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin
timeFrame: 104 weeks
measure: Post-treatment Period- Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Over-the-Counter Medication
timeFrame: 20 weeks
measure: Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period
timeFrame: week 124
measure: Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period
timeFrame: week 124
measure: Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period
timeFrame: week 124
measure: Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications
timeFrame: 20 weeks
measure: Post Treatment Period-Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Prescription Other Than Oral Isotretinoin
timeFrame: 20 weeks
Other outcomes:
measure: Post Treatment Period- Acne-Specific Quality of Life by Total Scores at the End of the Post-treatment Period
timeFrame: Visit 14/Week 124
measure: Post-treatment Period- Acne-Specific Quality of Life by Domain Scores at the End of the Post-treatment Period
timeFrame: Visit 14/Week 124
Locations:
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
Study officials:
affiliation: Ranbaxy Laboratories Limited
name: Ashish Anvekar, MD
role: STUDY_DIRECTOR
References:
citation: 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.