Full Press Release Details
- Tome Clearing Treatment is Dermata's second once-weekly skincare product under its Tome brand -
- Tome Clearing Treatment includes a salicylic acid wipe with Dermata's Bioneedle ™ mask and is expected to launch in H1 2027 for professionals and consumers -
SAN DIEGO, CA / ACCESS Newswire / October 29, 2026 / Dermata Therapeutics, Inc. (Nasdaq:DRMA) ("Dermata" or the "Company"), a science-driven leader in dermatologic solutions, today announced enrollment of the first participant in a clinical trial evaluating Tome Clearing Treatment, the Company's once-weekly acne treatment, in participants with acne. The Company expects to launch this second commercial product in H1 2027.
The initiation of this clinical trial marks another milestone in Dermata's strategy by adding a second product to its Tome skincare portfolio, targeting significant opportunities in the consumer skincare market. Acne affects approximately 50 million Americans annually, representing a substantial market for accessible, effective, and convenient treatment options. Tome Clearing Treatment kits salicylic acid, an FDA-recognized over-the-counter ("OTC") acne active ingredient, with Dermata's Bioneedle ™ powder in a differentiated once-weekly treatment regimen. The study is designed to evaluate improvements in acne lesions and post-inflammatory hyperpigmentation, with the goal of generating clinical evidence to support the product's planned commercialization.
"With our Tome Foundational Treatment for skin renewal now commercially available, we are focused on driving growth of our Tome skincare product portfolio and building a scalable business around our differentiated Bioneedle technology," said Gerry Proehl, Dermata's Chairman, President and Chief Executive Officer. "The initiation of this clinical trial represents an important step toward introducing our second Tome product, which we expect to launch in the first half of 2027. With most topical OTC acne treatments needing to be applied once or twice a day, we believe there is a meaningful commercial opportunity for an effective, convenient, once-weekly treatment that simplifies traditional acne care," Mr. Proehl continued. "Importantly, we believe our experience in dermatologic clinical development provides a competitive advantage as we build the Tome skincare brand. Our strategy is to combine differentiated products with clinical evidence that can help build consumer confidence, support our marketing efforts, and drive long-term growth," concluded Mr. Proehl.
Tome Clearing Treatment Clinical Trial Design
The clinical trial is expected to enroll approximately 24 participants with facial acne vulgaris in an open-label study. Participants will topically apply Tome Clearing Treatment once weekly for 12 weeks. A dermatologist will evaluate participants on endpoints including change from baseline in inflammatory and noninflammatory lesion counts, Investigator Global Assessment ("IGA") treatment response, and improvement in post-inflammatory hyperpigmentation. IGA is measured on a five-point scale from 0 to 4, with treatment response defined as at least a one-point improvement from baseline and an IGA score of 0 (clear) or 1 (almost clear). Participants may elect to continue treatment for an additional 12 weeks, which will help provide the Company with additional data regarding the safety and efficacy of Tome Clearing Treatment over an extended treatment period. The clinical data generated from this trial will help support marketing and commercialization of Tome Clearing Treatment.
Tome Clearing Treatment: A Once-Weekly Approach to Acne Care
Tome Clearing Treatment is a once-weekly acne routine powered by salicylic acid, an FDA-recognized OTC acne active ingredient, and Bioneedle ™ , Dermata's hero ingredient derived from 100% freshwater sponge that is wild harvested and minimally processed into a fine, purified powder. In addition to evaluating changes in acne lesions, the clinical trial will assess post-inflammatory hyperpigmentation, supporting Tome's broader focus on both acne and the appearance of skin affected by breakouts. The once-weekly format reflects Tome's approach to skincare: powerful, not punishing, with simple routines rooted in ancestral innovation, that are convenient for consumers.
Acne is one of the most common skin conditions in the United States, affecting approximately 50 million people. It can include noninflammatory lesions such as blackheads and whiteheads, inflammatory papules and pustules, and, in more severe cases, cysts and scarring. Acne can occur beyond adolescence and may affect the face, neck, chest, back, shoulders and upper arms. In addition to its physical effects, acne can have a negative impact on quality of life and self-esteem. Over 70% of patients with acne first choose to try multiple OTC products to treat their acne before seeking care from a dermatologist.
Tome is Dermata's skincare line focused on bringing about a new realm of skincare that is powerful, not punishing. Tome, in its literal meaning, is a large, important, scholarly book. Dermata intends to educate consumers with a brand that tells a skincare story rooted in science and history. Tome consists of skincare products utilizing a wild harvested freshwater sponge that has evolved over centuries, for consumers compelled by history and science to find potent natural products for their skincare routine. Dermata believes its Tome skincare line can simplify existing skincare routines with essential ingredients designed to deliver results, without harmful extremes.
Dermata Therapeutics is a science-driven leader in dermatologic solutions focused on the development and commercialization of both direct-to-consumer and professional skincare solutions. The Company leverages its experience in clinical dermatology and its Bioneedle technology to develop differentiated skincare products designed to address a variety of consumer skincare needs. Dermata's first commercial product, Tome Foundational Treatment, is now available at Tome , with its second planned product, Tome Clearing Treatment, expect to launch in H1 2027. Dermata is headquartered in San Diego, California. For more information, please visit Dermata .
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but are not limited to, statements related to: Dermata's shift to commercialize skincare products; the timing of any future announcements; the anticipated benefits of Dermata's strategic shift, including acceleration of its path to commercialization, market acceptance of its products, and expansion into broader consumer markets; the expected timing and success of any planned product launches; the potential market acceptance of any products; the proposed benefits any clinical data will provide any products; the Company's plan to incorporate study results into any marketing activities; whether the FDA will agree the Clearing Treatment complies with the applicable OTC monograph; and other factors described in the Company's filings with the Securities and Exchange Commission. These forward-looking statements are generally identified by the use of such words as "may," "could," "should," "would," "believe," "anticipate," "forecast," "estimate," "expect," "intend," "plan," "continue," "outlook," "will," "potential" and similar statements of a future or forward-looking nature. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in product development and commercialization. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.