Dermata Begins Acne Trial for Tome Clearing Treatment Ahead of Planned H1 2027 Launch
Dermata Therapeutics has enrolled the first participant in a clinical trial evaluating Tome Clearing Treatment, a once-weekly acne product planned for professionals and consumers.
Dermata Therapeutics (Nasdaq:DRMA) has enrolled the first participant in a clinical trial for Tome Clearing Treatment, a planned once-weekly acne product. The company expects the treatment to become the second commercial product in its Tome skincare line, with a potential launch in H1 2027 for professionals and consumers.
The open-label study is expected to include approximately 24 participants with facial acne vulgaris. Participants will apply Tome Clearing Treatment topically once weekly for 12 weeks.
A dermatologist will assess changes in inflammatory and noninflammatory acne lesion counts, treatment response and post-inflammatory hyperpigmentation. Treatment response will be evaluated using the Investigator Global Assessment, a scale from 0 to 4. Dermata defines a response as at least a one-point improvement from baseline alongside an IGA score of 0 or 1.
Participants may choose to continue treatment for an additional 12 weeks. Dermata said the extended period is intended to provide further safety and efficacy data.
Tome Clearing Treatment combines salicylic acid, described by the company as an FDA-recognized over-the-counter acne active ingredient, with Bioneedle™ powder. Dermata says Bioneedle™ is made from 100% freshwater sponge that is wild harvested and minimally processed into a fine, purified powder.
The clinical study will also examine post-inflammatory hyperpigmentation alongside acne lesions. Dermata said the resulting data is intended to support the product’s marketing and commercialization.
Tome Clearing Treatment is Dermata’s second planned product under the Tome skincare brand. The company’s first commercial product, Tome Foundational Treatment, is now available at Tome.
Dermata Chairman, President and Chief Executive Officer Gerry Proehl said the company is developing its Tome portfolio around its Bioneedle technology and clinical evidence. The company also said it sees a commercial opportunity in a once-weekly acne routine, noting that most topical over-the-counter acne treatments are applied once or twice a day.
Dermata stated that acne affects approximately 50 million Americans annually. The condition can involve blackheads, whiteheads, inflammatory lesions, cysts and scarring, and may affect quality of life and self-esteem. Over 70% of patients with acne first try multiple over-the-counter products before seeking care from a dermatologist.
The company’s planned H1 2027 launch, the outcome and use of clinical data, market acceptance and the product’s regulatory status remain subject to risks and uncertainties. Dermata specifically identified whether the FDA will agree that Clearing Treatment complies with the applicable over-the-counter monograph as a risk.
Dermata Therapeutics announced the enrolment of the first participant in a clinical trial evaluating Tome Clearing Treatment, its once-weekly acne treatment. The company expects the product to become its second commercial Tome skincare product.
Dermata Therapeutics announced the trial on October 29, 2026. The announcement covers the initiation of the clinical trial and the company’s expectation that Tome Clearing Treatment will launch in H1 2027.
Dermata Therapeutics expects to launch Tome Clearing Treatment in H1 2027 for professionals and consumers. The company describes this as a planned launch, and its release notes that product-launch timing and success remain subject to risks and uncertainties.
Dermata Therapeutics’ clinical trial is expected to enrol approximately 24 participants with facial acne vulgaris in an open-label study. Participants will apply Tome Clearing Treatment topically once weekly for 12 weeks, while a dermatologist evaluates acne lesions, treatment response and post-inflammatory hyperpigmentation.
The trial will measure changes from baseline in inflammatory and noninflammatory lesion counts, Investigator Global Assessment treatment response and improvement in post-inflammatory hyperpigmentation. Treatment response is defined as at least a one-point improvement from baseline and an IGA score of 0 or 1 on the five-point scale from 0 to 4.
Participants may elect to continue using Tome Clearing Treatment for an additional 12 weeks after the initial 12-week treatment period. Dermata Therapeutics says this will provide additional data regarding safety and efficacy over an extended treatment period.
Dermata Therapeutics says the clinical data will help support the marketing and commercialisation of Tome Clearing Treatment. The company also says its strategy is to combine differentiated products with clinical evidence to support marketing efforts and consumer confidence.
Tome Clearing Treatment uses salicylic acid, described by Dermata Therapeutics as an FDA-recognised over-the-counter acne active ingredient, together with Bioneedle™. The company says Bioneedle™ is derived from 100% freshwater sponge that is wild harvested and minimally processed into a fine, purified powder.
Dermata Therapeutics says most topical over-the-counter acne treatments need to be applied once or twice a day, and that it believes there is a commercial opportunity for an effective, convenient, once-weekly treatment. The company states that acne affects approximately 50 million Americans annually.
Tome is Dermata Therapeutics’ skincare line focused on products using a wild harvested freshwater sponge and on routines the company describes as “powerful, not punishing”. The company’s first commercial product, Tome Foundational Treatment, is now available at Tome, while Tome Clearing Treatment is its second planned product.
Dermata Therapeutics’ shares are listed on Nasdaq under the ticker symbol DRMA.
Dermata Therapeutics says the timing and success of the planned launch, market acceptance, the benefits of clinical data and whether the FDA will agree that Clearing Treatment complies with the applicable over-the-counter monograph are subject to risks and uncertainties. The company also cautions that actual events or results may differ materially from its forward-looking statements.