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Search / Trial NCT04594759

Weekly Isotretinoin Therapy Study

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Oct 14, 2020

Trial Information

Current as of April 25, 2025

Completed

Keywords

ClinConnect Summary

In current Dermatology practice, options for moderate acne vulgaris remain limited. Moderate acne is clinically defined as acne that has not responded to at least three months of topical therapy and is not severe enough for initial treatment with a conventional course of isotretinoin (formerly known as Accutane). The mainstay of treatment for moderate acne remains long courses of oral antibiotics, mainly tetracyclines (doxycycline, minocycline) and occasionally trimethoprim-sulfamethoxazole. Males with moderate acne, in particular, are especially limited in their treatment options as they a...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All patients 12 years and older with the diagnosis of moderate acne vulgaris
  • Exclusion Criteria:
  • Patients who are at baseline on long-term tetracycline antibiotics, long-term trimethoprim-sulfamethoxazole, or on spironolactone for any reason
  • Patients who have taken isotretinoin in the past 6 months
  • Patients with hypersensitivity to isotretinoin or to any of its components
  • Females who are pregnant, likely to become pregnant, or will be breast-feeding during the study period
  • Patients with a history of major depression, mania, or psychosis with an active episode during the past year including current psychotic symptoms and/or current suicidal ideation
  • Adult patients with cognitive impairment
  • Patients with baseline kidney or liver disease
  • Patients with baseline hypertriglyceridemia
  • Patients with history of or current pseudotumor cerebri
  • Patients with any clinically significant unstable medical condition which could pose a risk to the safety of the patient
  • Inability or unwillingness of subject or legal guardian/representative to give informed consent

Trial Officials

Samantha Karlin, MD

Principal Investigator

Medical University of South Carolina

About Medical University Of South Carolina

The Medical University of South Carolina (MUSC) is a leading academic health center dedicated to advancing medical research and improving patient care through innovative clinical trials. With a strong emphasis on translational medicine, MUSC leverages its extensive resources and expertise to facilitate groundbreaking studies across various medical disciplines. The institution is committed to fostering collaboration among researchers, healthcare professionals, and patients, ensuring that cutting-edge discoveries translate into effective treatments. As a pioneer in health education and research, MUSC plays a vital role in shaping the future of medicine and enhancing health outcomes in the community and beyond.

Locations

Charleston, South Carolina, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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