ABSORICA in Patients With Severe Recalcitrant Nodular Acne

Completed · Phase 4

Conditions studied: Acne

In brief

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.

Key facts

Study ID

NCT02457520

Run by

Sun Pharmaceutical Industries Limited

People needed

201

Starts

2015-01-21

Expected to finish

2018-04-01

Last updated by the study team

2021-04-27

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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