Weekly Isotretinoin vs Tetracycline for Moderate Acne
ConditionAcne Vulgaris
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Isotretinoin
DrugThis 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
DrugThis arm aims to serve as the comparison group. Tetracycline antibiotics are the current standard of care for the treatment of moderate acne.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: IsotretinoinExperimental treatment 1 intervention
Group B: TetracyclineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 monthsSecondary outcomes
1
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.
Time frame
4 months2
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.
Time frame
4 months3
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.
Time frame
4 months4
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.
Time frame
4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov