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
07 Juni 2024 - 2:15PM
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 IR516-222-2560IR@strataskin.com
Strata Skin Sciences (NASDAQ:SSKN)
Historical Stock Chart
Von Mai 2024 bis Jun 2024
Strata Skin Sciences (NASDAQ:SSKN)
Historical Stock Chart
Von Jun 2023 bis Jun 2024