Weekly Isotretinoin vs Tetracycline for Moderate Acne

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06225570
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Acne Vulgaris

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 1, 2025
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29403
Alexandra Richmond
843-792-3021

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By research site
Medical University of South Carolina· Charleston, SC

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