Weekly Isotretinoin vs Tetracycline for Moderate Acne

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Isotretinoin; Drug: Tetracycline

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Kathryn Keller, BS; Phone Number: 8646301689; Email: kellerka@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Recruiting
      • Medical University of South Carolina
      • Contact: Alexandra Richmond; Phone Number: 843-792-3021

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isotretinoin; Weekly isotretinoin (at 1-1.5 mg/kg per week) dose preceded by a 5-day daily loading dose (0.5-1 mg/kg/day). The weekly dose will be given once a week for 4 months.	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.
Active Comparator: Tetracycline; Daily oral doxycycline (weight-based dosing with maximum dose 200mg daily) or other tetracycline class antibiotic for a 4-month treatment period.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Alex Richmond, MD, MSCR, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: moderate acne vulgaris; isotretinoin
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Skin and Connective Tissue Diseases; Acne Vulgaris; Organic Chemicals; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Naphthacenes; Tetracyclines; Tetracycline; Isotretinoin
• Other Study ID Numbers: Pro00131877

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes