Isotretinoin vs Tetracycline for Acne

Overseen By Kathryn Keller, BS

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: Medical University of South Carolina

Must not be taking: Tetracyclines, Trimethoprim-Sulfamethoxazole, Spironolactone

Disqualifiers: Pregnancy, Depression, Liver disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks a better treatment for moderate acne by comparing two medications: Isotretinoin and Doxycycline, a tetracycline antibiotic. Isotretinoin is typically reserved for severe acne due to its side effects, but researchers are testing whether a weekly dose can safely and effectively aid those with moderate acne. Participants will take either weekly Isotretinoin or daily Doxycycline for four months to determine which is more effective and has fewer side effects. The study seeks males and females aged 12 and older with moderate acne who have not taken Isotretinoin in the past six months.

As an Early Phase 1 trial, this research focuses on understanding how these treatments work in people, offering participants a chance to contribute to groundbreaking advancements in acne treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on long-term Tetracycline antibiotics, Trimethoprim-Sulfamethoxazole, or Spironolactone.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking isotretinoin, a form of Vitamin A, once a week might effectively treat moderate acne. In a recent study, patients experienced acne improvement without major side effects. The FDA has already approved isotretinoin for severe acne, and its safety is well-established, providing reassurance despite the trial's early stage.

Conversely, antibiotics like doxycycline are commonly used for acne and have a long history of known safety. However, some individuals may experience side effects such as stomach issues and increased sensitivity to sunlight.

In summary, both treatments are considered safe, with isotretinoin showing promise as a potentially safer option in moderate doses. This trial aims to confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about isotretinoin for acne because it offers a unique dosing approach compared to current treatments like doxycycline, a tetracycline antibiotic. Unlike the usual daily dosing seen with most acne medications, isotretinoin in this trial is given weekly, following an initial loading phase. This could potentially reduce side effects and improve patient compliance by simplifying the treatment regimen. Additionally, isotretinoin targets acne differently by reducing oil production in the skin, while antibiotics primarily work by reducing bacteria and inflammation.

What evidence suggests that this trial's treatments could be effective for moderate acne?

This trial will compare Isotretinoin and Tetracycline for treating acne. Research has shown that isotretinoin could be a promising option for moderate acne. A large study found that 94% of patients using isotretinoin experienced good results, with noticeable improvement in their acne. Another study reported a 48.4% reduction in acne spots with isotretinoin use. For tetracycline, research indicates it effectively treats acne by stopping bacteria growth and reducing swelling. In a comparison study, about 78% of patients treated with doxycycline, a type of tetracycline, saw improvement. Both treatments seem promising, but isotretinoin may lead to a greater reduction in acne spots. ^{2 5 6 7 8}

Who Is on the Research Team?

Alex Richmond, MD, MSCR

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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 baseline hypertriglyceridemia

Patients with hypersensitivity to Isotretinoin or to any of its components

Patients with any clinically significant unstable medical condition which could pose a risk to the safety of the patient

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39813053/

Acne Relapse and Isotretinoin Retrial in Patients With Acne The findings of this cohort study suggest that higher cumulative dosage may potentially reduce risk of acne relapse and isotretinoin retrial ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4865340/

Is less more with isotretinoin and acne? - PMC A large prospective study (638 patients with moderate acne; 20 mg/d for 24 weeks) reported “good results” in about 94% of patients, decreased incidence of side ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.09.03.25335066v1.full

Evaluation of the Efficacy and Adverse Effects ... Results A total of 377 participants, aged between 21 and 25 years, were included In the study. A significant Improvement was reported by 74.5% ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jvc2.154

A systematic review of isotretinoin dosing in acne vulgaris One study used a dose of 20 mg on alternate days achieving very good results (more than 80% resolution of baseline acne) in 68.2% of patients, ...

5. aafp.org aafp.org/pubs/afp/issues/2024/0100/poems-acne-vulgaris.html

Network Analysis Finds Oral Isotretinoin Most Effective for ... Oral isotretinoin was the most effective agent at decreasing the number of lesions (relative reduction = 48.4%), followed by combination therapy (i.e., oral ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK525949/

Isotretinoin - StatPearls - NCBI Bookshelf FDA-Approved Indications. Isotretinoin is an oral medication that affects sebaceous glands and is used to treat severe acne. · Off-Label Uses.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2019/211913Orig1s000MultidisciplineR.pdf

211913Orig1s000 - accessdata.fda.gov Isotretinoin has been approved since 1982, and the safety profile is well-known. ABSORICA LD is proposed to participate in the established Risk.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4037971/

Safety and Efficacy of Low-Dose Isotretinoin in the ... Three months of treatment with low-dose isotretinoin (20 mg/day) was found to be effective in the treatment of moderate to severe acne vulgaris, with a low ...