The Fine Print Behind a 'First' Acne Treatment

A wire item this month carried a question and answer with Aaron Farberg, MD, about a three-phase approach to acne built around a product called Isoclear. The occasion was straightforward: Farberg is the medical director of Clear Health, the telehealth company that makes Isoclear, and the company had just announced its commercial launch with a headline calling it the first prescription topical isotretinoin system available in the United States. What the interview format leaves out is worth reading directly from the source: Clear Health's own product page, and the regulatory file the product actually sits in.

What Isoclear is, and what it isn't

Isotretinoin is the active ingredient in oral Accutane, approved by the FDA in 1982 for severe nodular acne after a formal review of safety and efficacy data. Isoclear delivers the same molecule topically, not orally, and it is not that kind of product. Per Clear Health's own safety disclosures, Isoclear "is a compounded formulation prepared by a licensed pharmacy pursuant to Section 503A of the Federal Food, Drug, and Cosmetic Act," and compounded medications, by definition, have not been evaluated by the FDA for safety, effectiveness, or quality. That is also why Isoclear does not require enrollment in iPLEDGE, the federal risk-management program built around oral isotretinoin's teratogenicity: iPLEDGE governs the approved oral drug specifically, and a compounded topical formulation sits outside that structure by construction, not because a trial has shown it carries less risk.

The three phases Farberg describes track a timeline Clear Health publishes on its own site: a "Clear" phase in the first four months aimed at active breakouts, a "Fade" phase from roughly four to six months targeting post-inflammatory marks, and a "Renew" phase after six months aimed at texture and maintenance.

The evidence footnote

Further down the same product page, in smaller type, Clear Health discloses something that complicates the headline:

Clinical studies referenced are based on the active ingredient, Isotretinoin, and not this specific compounded formulation. Compounded formulations are not FDA-approved. Some studies shown may reference branded products that may be marketed outside of the United States.

That sentence points to a real history the first-of-its-kind framing skips. A topical isotretinoin gel, sold under the brand Isotrex and later combined with erythromycin as Isotrexin, was approved and sold across the United Kingdom starting in 2002. It was never approved in the United States, and it was withdrawn from the UK market in January 2020, after which no isotretinoin skin preparation remained available there, according to national prescribing records. So Isoclear can accurately be called the first topical isotretinoin product commercially available in the U.S., a market Isotrex never entered. It is not the first anywhere, and the closest product to it did not survive its own market.

What the underlying science actually supports

The pharmacology behind topical isotretinoin is older and thinner than a launch announcement suggests. A frequently cited 1997 study in the Journal of Clinical Pharmacology found that even heavy daily application of a 0.1% isotretinoin cream over large body-surface areas produced smaller increases in plasma retinoid levels than a standard daily vitamin A supplement, evidence researchers took as reassuring on teratogenicity for that cream. It says nothing about Isoclear's specific formulation, concentration, or delivery vehicle. A broader review published in August 2025 in the journal Cureus, by researchers at the University of Texas Health Science Center and the Tilman J. Fertitta Family College of Medicine, described topical isotretinoin generally as remaining largely experimental, with limited availability, and said the field still lacks the randomized controlled trials needed to establish its optimal use.

None of this means Isoclear cannot work: oral isotretinoin's effect on sebum and acne is well established, and a topical route has a plausible rationale for reducing that effect locally and directly. Clear Health's own caution against use during pregnancy, offered voluntarily since iPLEDGE does not require it, suggests the company itself is not treating the teratogenicity question as closed.

Questions worth carrying into a conversation

• Has this specific compounded formulation, at its actual concentration, been tested in a published trial, or only the ingredient in other forms and other products?
• What does "compounded" change about oversight, batch consistency, and recourse if something goes wrong?
• Why doesn't iPLEDGE apply here: because the risk has been shown to be lower, or because the regulation was written around a different product category?

A dermatologist can answer all three in about the time it takes to walk through a three-phase chart. A press release cannot.

Sources: Clear Health, Isoclear product page · Cureus, "Topical Isotretinoin: Current Applications, Challenges, and Future Directions" (Aug. 2025)