Weekly Isotretinoin Vs Tetracycline for Moderate Acne

Early Phase 1

Not yet recruiting

• Conditions: Acne Vulgaris
• Interventions: Drug: Isotretinoin; Drug: Tetracycline

• Registration Number: NCT06225570
• Lead Sponsor: Medical University of South Carolina

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 Isot...

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 o...

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Study Start: 2025-01
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isotretinoin	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.
Tetracycline	Tetracycline	Daily oral doxycycline (weight-based dosing with maximum dose 200mg daily) or other tetracycline class antibiotic for a 4-month treatment period.

Primary Outcome Measures

Name	Time	Method
Efficacy using Comprehensive Acne Severity Scale	10 months	Determine the efficacy of weekly isotretinoin therapy for the treatment of moderate acne vulgaris compared to the current SOC therapy, systemic tetracyclines.

Secondary Outcome Measures

Name	Time	Method
Adverse Effect Questionnaire for isotretinoin	4 months	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.
Adverse Effect Questionnaire for SOC tetracycline	4 months	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.
Adverse Effects using Lipid Panel	4 months	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.
Adverse Effects using Liver Function Test	4 months	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.
Adverse Effects using Creatine phosphokinase	4 months	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.
Maintenance of treatment efficacy using Comprehensive Acne Severity Scale	10 months	Determine length of sustained treatment response after cessation of weekly isotretinoin or SOC systemic tetracycline therapy.
Patient satisfaction using Dermatology Life Quality Index scale	10 months	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.