Overview

Weekly Isotretinoin Therapy Study

Status:
Active, not recruiting
Trial end date:
2022-05-01
Target enrollment:
0
Participant gender:
All
Summary
In current Dermatology practice, options for moderate acne vulgaris remain limited. The mainstay of treatment for moderate acne remains long courses of oral antibiotics despite emerging antibiotic resistance. The efficacy of daily to twice daily dosed isotretinoin, an oral vitamin A derivative, for treatment of severe acne has been well established. The purpose of this study is to determine if once weekly dosed isotretinoin is effective for the treatment of patients with moderate acne. Additionally, the study aims to evaluate patient satisfaction and identify any adverse effects on this alternative dosing regimen.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of South Carolina
Treatments:
Isotretinoin
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