Phase 2
Completed N=22
Weekly Isotretinoin Therapy Study
Source: ClinicalTrials.gov NCT04594759 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Number of Participants That Showed Improvement in Their Visible Acne (Efficacy of Once Weekly Isotretinoin) — 18 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Showed Improvement in Their Visible Acne (Efficacy of Once Weekly Isotretinoin) |
18 | — |
| SECONDARY Number of Participants With a Change in Quality of Life |
17 | — |
| SECONDARY Number of Side Effects Reported at the End of 4 Months |
24 | — |
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
Data sourced from ClinicalTrials.gov (NCT04594759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.