STRATA Skin Sciences’ TheraClear®X Acne Therapy System Found to be Safe and Effective for Acne Lesions Across All Fitzpatrick Skin Types with Favorable Tolerability and Patient Satisfaction as Published in Peer Reviewed Journal
STRATA Skin Sciences announced the publication of a clinical study in the Journal of Clinical and Aesthetic Dermatology on the TheraClear®X Acne Therapy System. Conducted by Dr. Glynis Ablon, the study found TheraClear®X to be a safe and effective noninvasive treatment for mild to moderate acne with high patient satisfaction. The device, which combines vacuum and pulsed broadband light, showed significant reduction in acne lesions and visible improvements after three treatments. It was well-tolerated with no adverse events, and 80% of participants were satisfied with the treatment. Additionally, 87% would recommend it to others. The study concluded that TheraClear®X is especially beneficial for patients who find other acne treatments ineffective or poorly tolerated.
- Significant reduction in acne lesion counts at each visit compared to the baseline.
- Visible improvements as early as after 3 treatments.
- High patient satisfaction with 80% of participants satisfied or very satisfied.
- 87% of participants likely to recommend TheraClear®X treatment.
- No treatment-related adverse events reported.
- FDA-cleared device for noninvasive treatment of mild-to-moderate acne.
- Effective across all Fitzpatrick skin types.
- Consistent enhancements in patient Acne Quality of Life and satisfaction scores.
- Study was to a 7-week period, which may not reflect long-term efficacy and safety.
- Sample size of 30 participants may not be representative of the broader population.
Insights
STRATA Skin Sciences has announced positive results for their TheraClear®X Acne Therapy System, which could have substantial implications for the acne treatment market. This study indicates that photopneumatic therapy is a safe and effective option for treating mild-to-moderate acne in adolescents and young adults. This is a significant validation for TheraClear®X, offering a noninvasive alternative especially for patients who have found other treatments ineffective or intolerable.
The study demonstrates a
However, while the study presents promising data, it is worth noting that it is limited by its sample size of 30 participants and the open-label design. Future studies with larger, diverse populations and randomized controlled trials would provide more robust evidence. Nevertheless, the customizable settings and favorable tolerability are noteworthy advantages, making TheraClear®X a compelling option in the acne treatment landscape.
The market for acne treatment is vast, with millions affected globally, making the introduction of a new and effective treatment noteworthy. STRATA’s TheraClear®X offers a novel solution by combining vacuum technology with broadband light, potentially filling a niche for patients who find current treatments ineffective.
From a market perspective, the significant patient satisfaction and willingness to recommend could translate into
Additionally, the
However, the competition is fierce with numerous established products. The long-term commercial success will depend on strategic marketing efforts, further clinical validation and competitive pricing. Nonetheless, the initial data and patient feedback are promising, suggesting potential for significant market penetration.
Study published in the Journal of Clinical and Aesthetic Dermatology showed TheraClear®X Photopneumatic Acne therapy is a viable treatment option for patients with acne, especially for whom other acne treatments are ineffective or are poorly tolerated
HORSHAM, Pa., June 07, 2024 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (“STRATA” or the “Company”) (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, today announces the publication of a clinical study titled, " A 7-Week Open-Label Trial Evaluating the Safety and Efficacy of TheraClear®X for Mitigating Mild-to-Moderate Acne in Healthy Adolescents and Young Adults," in the June 2024 issue of the Journal of Clinical and Aesthetic Dermatology (JCAD). The study was conducted by Dr. Glynis Ablon, a board-certified dermatologist and Associate Clinical Professor UCLA, with 28 years of experience in medical, surgical, and aesthetic dermatology. Dr. Ablon runs the Ablon Skin Institute & Research Center and has published over 60 medical articles and has written three books. In the study, the TheraClear®X Acne Therapy System was found to be a safe and effective treatment for mild to moderate acne while providing a high degree of patient satisfaction.
“This study continues to enhance our growing portfolio of published articles demonstrating the viability and benefits of our product offering. This latest study in JCAD is important validation for our TheraClear®X system, and we look forward to sharing it with practitioners and potential customers,” said Dr. Dolev Rafaeli, STRATA’s President and Chief Executive Officer.
Dr. Ablon noted, “I am thrilled with the clinical study results for TheraClearX Acne System. The data clearly demonstrates TheraClear®X’s efficacy and safety, providing a significant improvement for Acne patients. Noninvasive devices are always needed in the acne armamentarium!”
STRATA’s TheraClear®X is a photopneumatic device that is FDA-cleared as a noninvasive, in-office treatment for mild-to-moderate acne, including comedonal, pustular, and inflammatory acne vulgaris. TheraClear®X combines gentle vacuum with pulsed broadband light to treat acne. The vacuum pulls dermal structures toward the skin surface and withdraws the contents of the follicles. Broadband light activates porphyrins to destroy Cutibacterium acnes and reduce sebum production. The vacuum is released when the process is completed. The treatment is administered through a handheld delivery system that is liquid-cooled for patient comfort and has no patient downtime. Treatment requires no pre-medication or anesthesia.
This study sought to evaluate the efficacy and safety of six weekly TheraClear®X treatment sessions as a stand-alone therapy. The results of the study are summarized below:
- Significant reduction in acne lesion counts at each visit compared to the baseline.
- ≥1 grade reduction in Investigator’s Global Assessment (IGA) for two-thirds (20/30) of participants by Day 49.
- Visible improvements as early as after 3 treatments.
- Consistent enhancements in patient Acne Quality of Life and satisfaction scores across all time points.
- Well-tolerated treatments with no treatment-related adverse events.
- High treatments satisfaction with
80% of participants reported being satisfied or very satisfied with the treatment. - High willingness to recommend with
87% of patients likely to recommend TheraClear®X Acne treatment to a friend.
The study concluded that photopneumatic monotherapy effectively reduces acne lesions across all Fitzpatrick skin types with favorable tolerability and participant satisfaction. Customizable settings allow tailored treatment for mild-to-moderate acne. TheraClearX photopneumatic therapy is a viable option especially for who other acne treatment options are ineffective or poorly tolerated.
The full study can be accessed on the following link: https://jcadonline.com/evaluating-photopneumatic-acne-healthy-adolescents/.
About STRATA Skin Sciences, Inc.
STRATA Skin Sciences is a medical technology company dedicated to developing, commercializing and marketing innovative products for the in-office treatment of various dermatologic conditions such as psoriasis, vitiligo, and acne. Its products include the XTRAC® excimer laser, VTRAC® lamp systems, and the TheraClear®X Acne Therapy System. STRATA is proud to offer these exciting technologies in the U.S. through its unique Partnership Program. STRATA’s popular partnership approach includes a fee per treatment cost structure versus an equipment purchase, installation and use of the device, on-site training for practice personnel, service and maintenance of the equipment, dedicated account and customer service associates, and co-op advertising support to help raise awareness and promote the program within the practice.
Safe Harbor
This press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to the Company’s plans, objectives, expectations and intentions and may contain words such as “will,” “may,” “seeks,” and “expects,” that suggest future events or trends. These statements, the Company’s ability to launch and sell an acne treatment device and to integrate that device into its product offerings, the Company’s ability to develop, launch and sell products recently acquired or to be developed in the future, the Company’s ability to develop social media marketing campaigns, direct to dermatologist marketing campaigns, and the Company’s ability to build a leading franchise in dermatology and aesthetics, are based on the Company’s current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from the Company’s expectations due to financial, economic, business, competitive, market, regulatory, adverse market conditions labor supply shortages, or supply chain interruptions resulting from fiscal, political factors, international conflicts, responses, or conditions affecting the Company, the medical device industry and our customers and patients in general, as well as more specific risks and uncertainties set forth in the Company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all these forward-looking statements may prove to be incorrect or unreliable. The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not undertake any obligation to update or revise these statements to reflect events or circumstances occurring after the date of this press release. The Company urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com.
Investor Contact:
CORE IR
516-222-2560
IR@strataskin.com
FAQ
What is the efficacy of TheraClear®X for mild-to-moderate acne as per the study?
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Were there any adverse events reported in the study of TheraClear®X?
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