Recruiting
Early Phase 1

Isotretinoin vs. Tetracycline

Sponsor:

Medical University of South Carolina

Code:

NCT06225570

Conditions

Acne Vulgaris

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

Isotretinoin

Tetracycline

Study Details

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.

Conditions

Acne Vulgaris

Study ID

NCT06225570

Start date

Feb 1, 2025

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Tetracycline

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

Interventions

Isotretinoin

This 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

This arm aims to serve as the comparison group. Tetracycline antibiotics are the current standard of care for the treatment of moderate acne.

Primary outcome measure

  • Efficacy using Comprehensive Acne Severity Scale [ Time Frame: 10 months ]

Central Contacts and Locations

Central contacts

Kathryn Keller, BS

8646301689kellerka@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29403

Contacts

Alexandra Richmond

843-792-3021

More Information

Sponsor

Medical University of South Carolina

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • moderate acne vulgaris
  • isotretinoin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-05-18.