Comparing weekly Isotretinoin to daily Tetracycline for moderate acne treatment
Randomized Controlled Trial of Weekly Oral Isotretinoin vs. Oral Tetracyclines for the Treatment of Moderate Acne Vulgaris
This study is testing if taking Isotretinoin once a week works better than taking Doxycycline every day for treating moderate acne in people aged 12 and older.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06225570 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of weekly Isotretinoin dosing compared to daily Doxycycline for treating moderate acne vulgaris. The study will involve male and female participants aged 12 and older who have been diagnosed with moderate acne. Participants will receive either weekly Isotretinoin or daily Doxycycline over a four-month period, with assessments of acne improvement, side effects, and patient satisfaction. The trial builds on previous promising findings regarding weekly Isotretinoin dosing, seeking to validate its potential as a safer alternative to long-term antibiotic use.
Who should consider this trial
Good fit: Ideal candidates for this study are males and females aged 12 years and older diagnosed with moderate acne vulgaris.
Not a fit: Patients currently on long-term antibiotics or with certain medical conditions, such as major depression or liver disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients with moderate acne that minimizes the need for long-term antibiotics.
How similar studies have performed: Previous studies have shown promising results with low-dose Isotretinoin for mild to moderate acne, but this specific weekly dosing approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Alex Richmond, MD, MSCR — Medical University of South Carolina
- Study coordinator: Kathryn Keller, BS
- Email: kellerka@musc.edu
- Phone: 8646301689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.