Clinical trial NCT06225570: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Acne Vulgaris
Keywords: moderate acne vulgaris
isotretinoin
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Efficacy using Comprehensive Acne Severity Scale
timeFrame: 10 months
Secondary outcomes:
measure: Adverse Effect Questionnaire for isotretinoin
timeFrame: 4 months
measure: Adverse Effect Questionnaire for SOC tetracycline
timeFrame: 4 months
measure: Adverse Effects using Lipid Panel
timeFrame: 4 months
measure: Adverse Effects using Liver Function Test
timeFrame: 4 months
measure: Adverse Effects using Creatine phosphokinase
timeFrame: 4 months
measure: Patient satisfaction using Dermatology Life Quality Index scale
timeFrame: 10 months
measure: Maintenance of treatment efficacy using Comprehensive Acne Severity Scale
timeFrame: 10 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Alex Richmond, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References: