NCT06225570 Weekly Isotretinoin vs Tetracycline for Moderate Acne
| NCT ID | NCT06225570 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Medical University of South Carolina |
| Condition | Acne Vulgaris |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2025-02-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Alex Richmond, MD, MSCR
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06225570 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Acne Vulgaris. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06225570 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06225570 currently recruiting?
Yes, NCT06225570 is actively recruiting participants. Contact the research team at kellerka@musc.edu for enrollment information.
Where is the NCT06225570 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT06225570 clinical trial?
NCT06225570 is sponsored by Medical University of South Carolina. The principal investigator is Alex Richmond, MD, MSCR at Medical University of South Carolina. The trial plans to enroll 50 participants.