Key Takeaways:
Steroid injections are the stealthy acne remedy for those painful pimples that literally pop up overnight. It’s one of those “if you know, you know,” treatments (and if you don’t know, count yourself lucky). An injection of diluted corticosteroid, such as triamcinolone acetonide, can dramatically reduce swelling and pain within 24 to 48 hours. The fix is fast, effective, and beloved by celebrities, news anchors, athletes, and anyone facing an on-camera, onstage, or otherwise in-your-face moment. The injection is easy and only takes a few minutes. The hardest part is getting a last-minute appointment with a dermatologist.
Dermatology appointments are typically booked weeks or months in advance. Long wait times are due to a shortage of dermatologists relative to the population's demand: the US has approximately 12,000 practicing dermatologists serving a population of around 330 million. This means the opportunity to get an urgent cortisone shot before a big meeting, wedding, or photo shoot is out of reach for most patients, and for good reason. Steroid injections involve a dermatologist carefully injecting a corticosteroid solution into the skin with a fine needle. This gold-standard treatment for spontaneous spots has been trapped inside dermatologists' offices, but potentially not for long.
Boston-based therapeutics company Indomo believes it can empower people to perform that procedure at home. The company’s investigational device, ClearPen, aims to transform the dermatologist-performed intralesional injection into a safe, self-administered, one-button microneedle treatment—available by prescription and used only when needed.
“Corticosteroid injections are the standard treatment for inflammatory acne. What we're developing is really a solution to replicate that same therapeutic procedure that dermatologists are doing in the office via a device that patients can use easily at home,” Rick Bente, CEO of Indomo, told BeautyMatter.
While still in development and not yet approved or cleared by the US Food and Drug Administration, new data suggests the device might be a viable alternative to in-office steroid injections. Early clinical trials demonstrated that self-administered, provider-prescribed intralesional treatments for inflammatory acne are both feasible and well-tolerated. If the FDA approves Indomo’s ClearPen, it could mark the most significant clinical shift in acne care since the approval of Accutane in 1982.
Why Acne Innovation Has Stalled
Acne affects up to 50 million Americans every year, yet the core clinical toolkit for treating individual, inflamed lesions has remained unchanged for decades. And, these treatments are only available to those who are lucky enough to get a same-day or next-day appointment at a dermatologist’s office. Even with the explosion of acne patches and modern OTC treatments, nothing available at home works as quickly or as reliably as a cortisone shot.
“It’s one of the standard ways to treat a pimple,” dermatologist Dr. Martin Zaiac told BeautyMatter. Zaiac is also a co-author of an early clinical trial evaluating the device concept. “I do it every day in my office. You inject a little bit of diluted steroid into the lesion, and it takes away the inflammation that causes the redness and pain.”
Unless you have a dermatologist on speed dial, this standard treatment is shockingly inaccessible. For Indomo, that gap represents acne’s biggest unmet need: true rapid intervention at home.
The concept for ClearPen originated when Indomo co-founder Jack Abraham—also co-founder of telehealth company Hims & Hers—reflected on the transformative experience he and his brother had with in-office injections dealing with inflammatory acne in their youth.
“For them, it was the first thing that really worked,” recalled Bente, who spent two decades of his career in the pharmaceuticals industry focused on drug delivery. “Once I understood that patient experience and paired it with today’s medical technology, it felt like the right time to finally move this treatment out of the office.”
To pull off this feat of pimple-popping engineering, Indomo assembled what can only be described as the Marvel Avengers team of dermatology, device design, and consumer skincare. Founded by veterans of Hims & Hers (Abraham), Medtronic (Bente), and Starface (Cara Davis), Indomo’s advisors include Brent Saunders, former CEO of Allergan; Patricia Walker, MD, PhD, former Chief Scientific Officer of Allergan Medical Aesthetics; Arash Mostaghimi, MD, Vice Chair of Clinical Trials and Innovation at Brigham & Women's Hospital Department of Dermatology and Associate Professor at Harvard; and Justin Ko, MD, Chief of Medical Dermatology and Professor at Stanford.
While a board of medical doctors and pharmaceutical experts is crucial, it’s the appointment of Davis as Chief Operating Officer that gives Indomo an edge.
“[Davis] comes from the world of skincare and acne, so she really understands what it takes to create a product people are going to really love and be advocates for,” said Bente. “We have something really special here. Building a start-up is a hard thing to do, and so she's had a huge amount of experience in helping really scale businesses like ours.”
Starface normalized acne, and Indomo hopes to borrow a few pages from the brand’s playbook to normalize at-home acne injections.
“We will look different than Starface,” Bente said with a laugh. “But we do plan to build on that same authentic, heartfelt foundation—and extend it into a more medical space.”
ClearPen’s Clinical Trials
But clinical feasibility—not branding—is what ultimately determines whether a prescription device can succeed. In the initial clinical study, Indomo partnered with dermatologists like Zaiac to explore whether patients could safely self-inject a corticosteroid using a device, and to establish the lowest dosage needed to achieve meaningful results.
ClearPen uses a microneedle about 1.5 millimeters long, deposited into the intradermal layer where inflammation typically occurs. The trials compared traditional dermatologist-administered injections with device-assisted self-injections at two concentrations of triamcinolone. The study cohort consisted of 131 participants, with 20 individuals receiving 0.1% triamcinolone injections administered by healthcare providers, 56 participants self-administering 0.1% triamcinolone injections, and 55 participants self-administering 0.2% triamcinolone injections.
“People in the study were shown how to do it, and they were very comfortable,” he said. “It’s a tiny needle [with] a small amount of medicine. The device lines itself up. You put it over the pimple, push a button, and in a few seconds, it’s over. You barely know what happened.”
The findings were compelling, according to Zaiac. Self-administered injections performed on par with provider-delivered ones, with no adverse events reported beyond minor bruising. Patients with more severe lesions sometimes responded faster to the higher dose, but even the lowest concentration proved effective.
In short, the data supported what dermatologists like Zaiac had long suspected: self-administered, clinician-prescribed intralesional injections for inflammatory acne are both feasible and safe. For Zaiac, who has performed these injections daily throughout his career, the results were a powerful validation that at-home corticosteroid injections could save both patients and providers time and effort.
“I think it's gonna be life changing for people,” he remarked. “They don't have to worry about missing a day of work to go to the dermatologist’s office, and for us, it’s a lot of work to try to squeeze people that have an emergency pimple into our schedule, and then do the paperwork required to get reimbursed by insurance.”
ClearPen will be prescribed, not sold over the counter, and Indomo expects insurance reimbursement to mirror current coverage of in-office injections.
Unlike many at-home interventions that spark fears of losing patients, ClearPen is being embraced by dermatologists like Zaiac. Patients will still need to see physicians for diagnosis, prescriptions, and ongoing care, especially because ClearPen is not designed for chronic, active acne.
“This device is for that one nuisance pimple—the emergency pimple,” said Zaiac. “It’s not for someone with active acne. Those patients still need medical treatment. But for someone who gets a big pimple occasionally, it’s going to make their life a lot better.”
The FDA’s ability to discuss pending Investigational New Drug applications is limited by federal law, but an FDA spokesperson told BeautyMatter that the agency’s core concerns are safety and effectiveness, for any drug product. While ClearPen contains a treatment long used by dermatologists in-office, the representative emphasized that innovative combination products introduce new scientific and technical considerations that must be addressed to ensure safety, effectiveness, and quality.
“Although a combination product may be comprised of an already approved drug and an already approved device, new scientific and technical issues may emerge when the drug and device are combined or used together,” the FDA spokesperson said. “New methodologies may need to be developed for manufacturing, evaluation of preclinical safety in targeted areas of the body, or clinical trial design to establish safety and effectiveness.”
How GLP-1s Normalized Needles at Home
Self-injection once carried significant patient fear, but that’s changed in recent years. Today, millions self-inject GLP-1 agonists like Ozempic on a weekly basis, and millions more routinely get Botox and fillers injected annually. Needles no longer carry the stigma they once did.
“The injection intimidation has gone away,” Bente said. “And because our needle is a microneedle, you never really see it.”
ClearPen also occupies a completely different space from other acne treatments or skincare products. It isn’t competing with retinoids, antibiotics, benzoyl peroxide, or isotretinoin. Instead, it slots into a lane that has never had a reliable, scalable at-home solution: the urgent, high-impact pimple that appears at exactly the wrong time. Many patients who suffer from these breakouts aren’t in the throes of chronic acne; they might be past their teenage years, managing generally clear skin, but still dealing with the occasional stress-related or hormonal eruption that feels impossible to ignore.
For these patients, ClearPen functions as a rapid, targeted solution that’s closer to a first-aid intervention than a skincare product. Millions of people experience episodic breakouts, and while they may not need systematic treatments, they do need something that works quickly—ideally within hours, not days or weeks. While acne prevention, spot treatments, and post-acne solutions are crowded categories, the acute intervention segment is ripe for reinvention.
“ClearPen is creating a new category of treatment for individual lesions, but we will be part of the broader acne care ecosystem,” said Bente. “This is really designed to help treat a specific pimple that's already gotten to the point of inflammation. It’s one more tool in the toolbox for dermatologists and for patients to kind of deal with those individual inflamed lesions that pop up occasionally."
The device sits squarely at the intersection of clinical efficacy and consumer convenience, making it uniquely well-timed for a world increasingly comfortable with at-home medical care, and one that has also grown accustomed to solutions that promise immediate results.
The Road Ahead for Indomo and ClearPen
If ClearPen proves that intradermal injections can be safely and effectively delivered at home, Indomo sees the potential for a much broader platform. The corticosteroid used in the device, triamcinolone, is already a staple treatment for conditions beyond acne—including hypertrophic scars, alopecia areata, keloids, and hidradenitis suppurativa—which opens the door for ClearPen to evolve into a tool for a range of dermatologic concerns.
But Bente’s vision extends well past corticosteroids. “There are a lot of drugs that are in development today that don't really have a clear pathway to the general consumer market,” he said. “We have the opportunity to really play a strong role in continuing to shift care from in-office applications into the home where it makes sense.”
ClearPen will enter Phase 2 clinical trials next year, focusing on dosing, safety, and user experience. Phase 3 trials will use the final commercial version. Indomo originated in Abraham’s venture studio, Atomic, and has since raised approximately $25 million from Atomic, Foresite Capital, and Polaris Partners to hopefully bring this medical device to the market.
FDA approval is still a multiyear process, but for now, Indomo’s focus is on preparing the device and drug for trial, and recruiting patients and providers to ensure the study runs efficiently. Throughout the process, Bente said the team will continue working closely with regulators to provide robust data and a clear articulation of the opportunity the company aims to deliver.
ClearPen signals where skincare innovation is heading: away from a product-driven marketplace and into a device-centric future. There’s a long regulatory road ahead, but early data from ClearPen offers a glimpse into a future in which dermatology isn’t confined to the clinic. Patients will soon have access to on-demand, medical-grade solutions—a transformation in the evolution of acne care.
“There hasn't been a lot of innovation in the acne space,” observed Bente. “What [Davis] and her team did with Starface was probably one of the last really big changes in the acne care market, and we're excited for this to be the next big step.”
