Could Topical Isotretinoin Expand Acne Treatment Options?

Oral isotretinoin remains one of the most effective treatments for acne but carries significant prescribing requirements through the FDA's iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). In a recent Dermatology Times video interview, Aaron Farberg, MD, discussed Isoclear, a compounded topical isotretinoin system he helped develop that aims to deliver isotretinoin directly to the skin while avoiding systemic exposure associated with oral therapy.¹²

Clear Health recently announced the commercial launch of Isoclear, describing it as the first prescription topical isotretinoin system available in the United States. According to the company, the formulation is designed to offer clinicians a personalized alternative for patients seeking an option between traditional topical therapies and oral isotretinoin.

MORE ON ACNE

A Personalized Approach to Topical Isotretinoin

Unlike conventional topical retinoids prescribed at a fixed strength, Farberg described Isoclear as an evolving, multi-phase treatment system built around the concept of skin cycling rather than a single static formulation.²

Unlike a static one-and-done prescription retinoid cream, Isoclear isn't just the product; it's actually an evolving multi-phase system, — Aaron Farberg, MD, FAAD,

According to Farberg, the compounded formulation allows clinicians to modify topical prescriptions throughout treatment based on changes in acne severity and skin barrier function. Because each prescription is compounded, he said the formulation can be adjusted over time to better match an individual patient's needs.

"Because it's compounded, we can actually dynamically adjust it to create a more personalized formulation over time that matches exactly what's going on with the patient's acne and their skin barrier," Farberg said.

Farberg said the formulation is intended to work directly within the skin by modulating sebaceous gland activity, regulating keratinocytes, and normalizing skin turnover—mechanisms consistent with isotretinoin and other retinoid therapies.³

Which Patients May Benefit?

Farberg said Isoclear may be appropriate for patients with persistent mild, moderate, or severe acne, particularly those with excessive oil production and recurring breakouts who desire the efficacy associated with isotretinoin but may not be ideal candidates for oral treatment.

He identified several patient populations that may benefit, including individuals hesitant to take oral medication because of potential adverse effects, patients wishing to avoid the laboratory monitoring associated with oral isotretinoin, and women of childbearing potential seeking a non-systemic acne treatment option.¹³

Bypassing iPLEDGE

A key distinction discussed during the interview was Isoclear's compounded status.

Because Isoclear is compounded rather than an FDA-approved oral isotretinoin product, it is not subject to the FDA's iPLEDGE REMS program, which requires prescriber and pharmacy certification, patient enrollment, pregnancy testing, and ongoing monitoring for patients receiving oral isotretinoin.¹

Farberg said this may simplify treatment discussions for some patients, particularly women of childbearing potential who are reluctant to undergo the monitoring required for oral isotretinoin.

Evidence and Clinical Considerations

Although isotretinoin has decades of evidence supporting its use as an oral therapy, published evidence specific to Isoclear remains limited.

To date, no peer-reviewed clinical trials evaluating the efficacy, pharmacokinetics, or long-term safety of the compounded formulation have been identified in the medical literature. Likewise, the product has not undergone the FDA approval process required for marketed prescription drugs.

As with other compounded medications, dermatologists considering Isoclear may wish to review formulation-specific information regarding potency, stability, and safety while weighing currently available evidence before incorporating the therapy into practice.²

Farberg believes compounded topical isotretinoin may help fill an important treatment gap for select patients who want the biologic activity of isotretinoin without systemic therapy. Whether broader adoption follows will likely depend on future independent studies evaluating efficacy, safety, and long-term clinical outcomes.

References:

1. iPLEDGE REMS Program. US Food and Drug Administration. Accessed July 22, 2026. https://ipledgeprogram.com/
2. Clear Health launches Isoclear, the first prescription topical isotretinoin system for acne treatment in the U.S. News release. Business Wire. June 17, 2026. Accessed July 22, 2026. https://www.businesswire.com/news/home/20260617471674/en/Clear-Health-Launches-Isoclear-the-First-Prescription-Topical-Isotretinoin-System-for-Acne-Treatment-in-the-U.S.
3. Clear Health launches topical isotretinoin acne treatment without iPLEDGE requirements. Dermatology Times. Published June 18, 2026. Accessed July 22, 2026. https://www.dermatologytimes.com/view/clear-health-launches-topical-isotretinoin-acne-treatment-without-ipledge-requirements