Weekly Isotretinoin vs Tetracycline for Moderate Acne

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06225570
• Other study ID #: Pro00131877
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: January 2025
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy using Comprehensive Acne Severity Scale	Determine the efficacy of weekly isotretinoin therapy for the treatment of moderate acne vulgaris compared to the current SOC therapy, systemic tetracyclines.	10 months
Secondary	Adverse Effect Questionnaire for isotretinoin	Compare the adverse effect profiles of weekly isotretinoin and SOC systemic tetracyclines when used for treatment of acne vulgaris. The questionnaire is written by study members asking patients if they experienced common side effects known to either medication.	4 months
Secondary	Adverse Effect Questionnaire for SOC tetracycline	Compare the adverse effect profiles of weekly isotretinoin and SOC systemic tetracyclines when used for treatment of acne vulgaris. The questionnaire is written by study members asking patients if they experienced common side effects known to either medication.	4 months
Secondary	Adverse Effects using Lipid Panel	Compare the adverse effect profiles of weekly isotretinoin and SOC systemic tetracyclines when used for treatment of acne vulgaris. Specifically the incidence of elevated triglycerides and elevated cholesterol will be recorded both based on the physiologic parameters measured in mg/dL.	4 months
Secondary	Adverse Effects using Liver Function Test	Compare the adverse effect profiles of weekly isotretinoin and SOC systemic tetracyclines when used for treatment of acne vulgaris. Specifically the incidence of elevated alanine transaminase and elevated aspartate transaminase will be recorded both based on the physiologic parameters measured in IU/L.	4 months
Secondary	Adverse Effects using Creatine phosphokinase	Compare the adverse effect profiles of weekly isotretinoin and SOC systemic tetracyclines when used for treatment of acne vulgaris. Specifically the incidence of elevated creatine phosphokinase will be recorded based on the physiologic parameters measured in IU/L.	4 months
Secondary	Patient satisfaction using Dermatology Life Quality Index scale	Discern patient satisfaction with weekly isotretinoin or SOC systemic tetracyclines for acne treatment. Minimum score is 0, maximum score is 30. The higher the score the more patient quality of life is impaired.	10 months
Secondary	Maintenance of treatment efficacy using Comprehensive Acne Severity Scale	Determine length of sustained treatment response after cessation of weekly isotretinoin or SOC systemic tetracycline therapy.	10 months