RecruitingEarly Phase 1NCT06225570

Weekly Isotretinoin vs Tetracycline for Moderate Acne

Randomized Controlled Trial of Weekly Oral Isotretinoin vs. Oral Tetracyclines for the Treatment of Moderate Acne Vulgaris


Sponsor

Medical University of South Carolina

Enrollment

50 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Summary

In the effort to find better treatments for Moderate Acne, which often relies on long-term antibiotic use, researchers are exploring alternative options. While Isotretinoin, a Vitamin A derivative, is highly effective for severe acne, its side effects limit its use for milder cases. A recent study from our institution investigated a new approach: weekly Isotretinoin dosing. The results were promising, with acne improvement and no major side effects. This suggests that weekly Isotretinoin could be a successful alternative for moderate acne in both males and females. To validate these findings, investigators propose a randomized controlled trial comparing weekly Isotretinoin to daily Doxycycline over four months. This study could confirm the safety and effectiveness of weekly Isotretinoin, as well as shed light on patient satisfaction, and long-term results compared to standard antibiotics. This research may offer a breakthrough in treating moderate acne while addressing concerns about antibiotic overuse.


Eligibility

Min Age: 12 Years

Inclusion Criteria1

  • \- Male and Female patients, 12 years and older with a diagnosis of Moderate Acne Vulgaris

Exclusion Criteria11

  • 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

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Interventions

DRUGIsotretinoin

This arm aims to study the effectiveness, side effects and patient satisfaction of taking isotretinoin on a weekly basis as opposed to current standard daily dosing.

DRUGTetracycline

This arm aims to serve as the comparison group. Tetracycline antibiotics are the current standard of care for the treatment of moderate acne.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06225570