Expired Study
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San Antonio, Texas 78218


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

ABS157LT


NCT ID:

NCT02457520


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

12 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sun Pharmaceutical Industries Limited


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Ashish Anvekar, MD
Study Director
Ranbaxy Laboratories Limited

Study Dates

Start Date:January 21, 2015
Completion Date:April 2018
Completion Type:Actual
Primary Completion Date:April 2018
Primary Completion Type:Actual
Verification Date:November 2018
Last Changed Date:November 2, 2018
First Received Date:May 16, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Treatment safety (local skin irritation)
Time Frame:20 weeks
Safety Issues:False
Description:Treatment safety as determined by local skin irritation
Outcome Type:Secondary Outcome
Measure:Treatment safety (adverse events)
Time Frame:20 weeks
Safety Issues:False
Description:Treatment safety as determined by the frequency and severity of adverse events
Outcome Type:Secondary Outcome
Measure:Change from baseline in the Investigator's Global Assessment (IGA)
Time Frame:20 weeks
Safety Issues:False
Description:Change from baseline in the IGA at the end of the active treatment period in subjects who complete the 20-week active treatment period
Outcome Type:Secondary Outcome
Measure:Change from baseline in the acne-quality of life (QOL) score
Time Frame:20 weeks
Safety Issues:False
Description:Change from baseline in the acne-QOL score
Outcome Type:Secondary Outcome
Measure:Change from baseline in the lesion count
Time Frame:20 weeks
Safety Issues:False
Description:Change from baseline in the lesion count (nodules and inflammatory lesions) at the end of the ATP.
Outcome Type:Primary Outcome
Measure:Quality of life (QOL) of subjects who are taking Absorica® (isotretinoin)
Time Frame:20 weeks
Safety Issues:False
Description:Change from Baseline to the end of active treatment period (ATP) at week 20 in the acne-specific quality of life (acne-QOL) questionnaire score for those subjects who complete the 20-week ATP and are at least 75% compliant with the treatment regimen (isot

Study Interventions

Intervention Type:Drug
Name:Isotretinoin
Description:ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Arm Name:Single treatment arm
Other Name:ABSORICA

Study Arms

Study Arm Type:Experimental
Arm Name:Single treatment arm
Description:ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sun Pharmaceutical Industries Limited

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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