Isotretinoin vs Tetracycline for Acne

Overseen By Penny Smith, MS

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: Medical University of South Carolina

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 0

Duration: 16 weeks

50 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Alex Richmond, MD, MSCR

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for males and females aged 12 or older who have been diagnosed with Moderate Acne Vulgaris. It's designed to test a new treatment approach that could reduce the need for long-term antibiotics.

Inclusion Criteria

I am 12 or older and have been diagnosed with moderate acne.

Exclusion Criteria

Patients with hypersensitivity to Isotretinoin or to any of its components

Patients with baseline hypertriglyceridemia

I am not pregnant, trying to get pregnant, or breastfeeding during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either weekly isotretinoin or daily doxycycline for moderate acne treatment

16 weeks

Weekly visits for isotretinoin group, monthly visits for doxycycline group

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 months

Treatment Details

Interventions

• Isotretinoin
• Tetracycline

Trial Overview Researchers are comparing weekly doses of Isotretinoin, a Vitamin A derivative, to daily Doxycycline over four months in patients with moderate acne. The study aims to confirm if this less frequent dosing is safe and effective.

Participant Groups

Group I: Isotretinoin Experimental Treatment 1 Intervention

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.

Group II: Tetracycline Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+