Clear Health Launches Topical Isotretinoin System Bypassing iPLEDGE Requirements

Clear Health has launched Isoclear, a compounded topical isotretinoin system that bypasses the FDA's iPLEDGE REMS program, giving your clinic a way to prescribe this gold-standard acne molecule without the burden of mandatory pregnancy testing and laboratory monitoring.

The prescription treatment operates as a customized, three-phase system called Clear, Fade, and Renew. It pairs topical isotretinoin with other ingredients including clindamycin, tranexamic acid, niacinamide, and copper peptide (GHK-Cu) to dynamically target the skin barrier. Patients pay $50 per month, or $100 for a two-month supply, with prices dropping to $40 per month depending on the plan.

Because Isoclear is a compounded product, it does not have FDA approval. It is critical to note that there are currently no peer-reviewed clinical trials in medical literature evaluating the efficacy, pharmacokinetics, or long-term safety of this specific topical formula. While it offers a flexible, personalized option for patients who cannot tolerate or access oral isotretinoin, you will want to weigh the clear scheduling benefits of avoiding iPLEDGE registration against the lack of published safety data when discussing this option with acne patients.

Source: Dermatology Times, https://www.dermatologytimes.com/view/could-topical-isotretinoin-expand-acne-treatment-options-