Weekly Isotretinoin vs Tetracycline for Moderate Acne

Official title

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

Overview

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.

Detailed description

In current practice, treatment options for Moderate Acne Vulgaris remain limited. The mainstay of treatment remains long courses of oral antibiotics, mainly Tetracyclines. With the growing discussion of antibiotic stewardship, alternate and more effective therapies need to be explored. The efficacy of Isotretinoin, a Vitamin A derivative, for the treatment of Acne, has been well-established, but its use is often limited to treatment of severe Acne due to its possible side effects and standard lab monitoring. Several studies have explored low-dose Isotretinoin for Mild-to- Moderate Acne with promising results, however, to our knowledge, the first study looking at weekly dosing of Isotretinoin was conducted at our institution. In this proof-of-concept study, results showed improvement of Acne in almost all patients with no significant lab abnormalities or adverse events. Investigators concluded that weekly Isotretinoin dosing is a potential efficacious alternative for the treatment of Moderate Acne in both males and females and suggested study replication with a larger population and with comparison to standard of care (SOC) treatments. For these reasons, Investigators propose a randomized controlled trial comparing the efficacy of once weekly oral Isotretinoin dosing preceded by a 5-day daily loading dose to daily oral Doxycycline over a 4-month treatment period. This study has the potential to confirm the safety and efficacy of weekly dosed Isotretinoin for Moderate Acne treatment and highlight its adverse event profile, clinical effectiveness, patient satisfaction, and degree of sustained treatment response after drug cessation in comparison to standard of care Tetracyclines.

Interventions

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

Primary outcome measures

• Efficacy using Comprehensive Acne Severity Scale [Time frame: 10 months]

Secondary outcome measures (7)

• Adverse Effect Questionnaire for isotretinoin [Time frame: 4 months]
• Adverse Effect Questionnaire for SOC tetracycline [Time frame: 4 months]
• Adverse Effects using Lipid Panel [Time frame: 4 months]
• Adverse Effects using Liver Function Test [Time frame: 4 months]
• Adverse Effects using Creatine phosphokinase [Time frame: 4 months]
• Patient satisfaction using Dermatology Life Quality Index scale [Time frame: 10 months]
• Maintenance of treatment efficacy using Comprehensive Acne Severity Scale [Time frame: 10 months]

Eligibility criteria

Inclusion criteria

\- Male and Female patients, 12 years and older with a 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Medical University of South Carolina — Charleston

Identifiers

NCT: NCT06225570 · Pro00131877

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗