ABSORICA in Patients With Severe Recalcitrant Nodular Acne

NCT02457520 | Completed Phase 4 Results

• 1 other identifier: ABS157LT
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (15)

• Active Treatment Period- Change From Baseline in Lesion Counts at Week 20

  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

  Baseline, at week 4, week 8, week 12, and week16

• Active Treatment Period- Investigator's Global Assessment at Week 20

  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

  20 weeks

• Active Treatment Period- Change From Baseline in Nodule Count at Week 20

  Baseline, and at week20

Other Outcomes (2)

• Post Treatment Period- Acne-Specific Quality of Life by Total Scores at the End of the Post-treatment Period

  Visit 14/Week 124

• Post-treatment Period- Acne-Specific Quality of Life by Domain Scores at the End of the Post-treatment Period

  Visit 14/Week 124

Study Arms (1)

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.

Drug: Isotretinoin

Interventions

Isotretinoin DRUG

ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks

Also known as: ABSORICA

Single treatment arm

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (1)

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Related Publications (1)

• 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.

  PMID: 32038751 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Clinical Trials
• Organization: SPIL

Clinical.Trials@sparcmail.com

912266455645

Study Officials

• Ashish Anvekar, MD

  Ranbaxy Laboratories Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2015
• First Posted: May 29, 2015
• Study Start: January 21, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 27, 2021
• Results First Posted: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)