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Having acne can be debilitating: this is something I learnt last year when I developed terrible hormonal breakouts at 33. So, innovation in dermatology is always welcome to patients, and the current tech garnering the most media traction is Indomo’s ClearPen. A US-born at-home acne injection device, the brand’s team hopes ClearPen will bridge the gap between professional and at-home acne treatments and revolutionise the space. But what do UK dermatologists think?
It’s important to note that ClearPen is still in the early stages of development in the US and is not approved for use outside of clinical trials as it stands. Indomo is hoping this changes very soon, so it can reach acne sufferers in America. With this in mind, availability in the UK is not guaranteed and is certainly not expected in the immediate future. Here’s what you need to know about ClearPen.
What is the Indomo ClearPen?
Indomo is a Boston-based clinical-stage therapeutics company, founded by a team with prior experience with brands like Starface and advisors including the Director of Inpatient Dermatology at Harvard. The brand’s ClearPen device uses microneedle technology to deliver a reformulated triamcinolone acetonide formulation, a corticosteroid used to treat inflammatory lesions (such as acne).
The pen is designed for daily use, delivering low-dose intralesional (within a lesion or spot) injections into areas of acne. The idea is that acne sufferers can enjoy the same technology that is usually reserved for in-office treatments administered by dermatologists (often referred to as ‘cortisone shots’). Currently, you can only access these injections via a professional, both here and across the pond.
“From the information available, the ClearPen appears to be a micro-injection delivery device designed to administer acne medication directly into the skin at controlled depths and doses,” confirms Dr Aiza Jamil, Dermatologist at SK:N Clinics. “The idea is to target the pilosebaceous unit more precisely than topical treatments, potentially reducing inflammation and lesion formation while limiting systemic exposure. It essentially combines drug delivery with device technology to improve accuracy and consistency.”
How is it different from any other acne treatment?
The main point of difference is the fact it’s the first of its kind in at-home acne treatment. The goal of the founders was to bridge the gap between expensive, often inaccessible dermatology appointments, and regular acne go-to’s easily available to us, like topical products.
According to Cara Davis, COO at Indomo, the ClearPen also has a higher level of efficacy versus traditional approaches. “At-home topical treatments for acne do not penetrate deep beneath the skin’s surface, while oral medications do not deliver targeted treatment to individual lesions. Unlike topicals, when a physician injects triamcinolone acetonide, it ensures that the drug gets directly to the site of inflammation quickly.”
She continues: “Intralesional triamcinolone acetonide injections have 50+ years of real-world clinical experience and are recommended by the American Academy of Dermatology as a first-line treatment for inflammatory lesions. We believe the ClearPen will revolutionise acne care by providing patients access to these injections from the comfort of their home.”
What do dermatologists think?
While the technology sounds innovative and the prospect exciting (especially for long-term acne sufferers), UK dermatologists I spoke with had their doubts about how this new approach would work.
For Dr Jamil, the problem lies largely in the fact that non-skin experts will have access to a technology previously reserved for professional dermatologists with years of training. “The main concerns would be safety, user error and suitability. Injectables always carry risks such as infection, irritation, incorrect depth of delivery or scarring if not used properly,” she says.
Dr Stefanie Williams, Dermatologist and Medical Director of EUDELO, worries that approaches such as this may not be able to account for each individual case. “The pen does not allow tailoring the treatment to each patient and each acne lesion (which is important),” she begins. In-clinic, cortisone injections can be adjusted specifically for each patient and on a case-by-case basis, pimple to pimple. “The pen, in contrast, contains a lower concentration of active ingredient and always injects the same amount into the same depth, no matter how big or small, how superficial or deep the treated acne lesion is.”
She concludes: “The selection of the correct type of acne lesion is vital for intralesional steroid injections. I would only inject a small fraction of acne lesions with steroids, if at all, and only as ‘an emergency’ symptomatic treatment to bring down a strongly inflamed lesion, for example, a special event.” Williams believes the ClearPen could be useful for specific scenarios (such as a sudden large pimple before your wedding day), but not for routine acne treatment. It also treats acne symptoms rather than the root cause, she says.
When asked about these potential safety and suitability issues, however, Davis commented: “The clinical evidence we are generating in our trials will demonstrate the safety of this product for at-home use. Like other at-home injectable medications, the ClearPen system will be a prescription product, so physicians will be directly involved in the care of patients who use the system. We expect to have services that help ensure patients have easy access to physicians who can help them manage their individual acne journey.”
She continued: “We strongly believe in developing systems that are easy to use and difficult to misuse. Our system will have comprehensive instructions and guides to ensure proper use and those instructions are part of the regulatory review and approval process. The ClearPen will be an important part of an overall acne treatment regimen, but it is designed to heal individual cysts or nodules, rather than act as a preventative treatment. We expect patients will also be using preventative treatments for their overall acne in combination with the ClearPen system.”
Will the acne injection pen be coming to the UK?
Before we even think about UK approval, we have to stop to consider where the ClearPen is at currently in its home country: the US. “Right now, the ClearPen is investigational and only available through clinical trials,” notes Davis. It is therefore awaiting FDA approval (following its phase 3 trials, which will occur after the current round) to be prescribed by dermatologists and other doctors.
The brand does “see the UK as a strong potential future market for the ClearPen,” according to Davis, but their current focus is on “proving strong clinical, economic, and patient value in the US.” After that, they “believe international expansion, including the UK, becomes a very achievable next step” via the “appropriate UK regulatory approvals.”
This could take some time. “The UK has very robust regulatory standards for injectable treatments, particularly those used at home, so approval would require strong evidence around safety, efficacy and appropriate patient selection,” says Dr Jamil, despite acknowledging “there is certainly consumer demand for more effective at-home acne solutions” currently.
Medical Director and Dermatology Expert Dr Naomi Mackle adds that the way we view and approach acne injections here may also play a big role in their availability in the future. “I think there would be significant hurdles. Steroid use is tightly regulated for good reason. In my view, innovation in dermatology is always welcome, but patient safety must always come first.” Time will tell.
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