This section highlights FDA-related milestones and regulatory updates for drugs developed by Strata Skin Sciences (SSKN).
Over the past two years, Strata Skin Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TheraClear®X and XTRAC. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
TheraClear®X FDA Regulatory Timeline and Events
TheraClear®X is a drug developed by Strata Skin Sciences for the following indication: Treatment of acne.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TheraClear®X
- Announced Date:
- October 28, 2025
- Indication:
- Treatment of acne
Announcement
STRATA Skin Sciences, Inc. announced that its TheraClearX® acne treatment system has received regulatory clearance from the Mexican health authority, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), under Device Registration No. 3187E2024SSA, valid through November 2029.
AI Summary
STRATA Skin Sciences, Inc. announced its TheraClearX® acne treatment system has been cleared by COFEPRIS, Mexico’s health authority. The clearance, under Device Registration No. 3187E2024SSA, is valid through November 2029 and allows TheraClearX® to be imported, sold, and used across Mexico.
COFEPRIS reviewed safety and quality data, confirming TheraClearX® meets Mexico’s strict device standards.
STRATA has teamed up with MINO Labs for a nationwide launch. The first TheraClearX® device is now live with Dr. Melissa Lomelí Canedo in Mexico City. Her clinic will use photopneumatic technology to deeply clean pores and treat acne with light therapy.
Mexico has about 3,000 dermatologists, many lacking advanced device options. STRATA will expand its rollout and train clinicians through MINO Labs. The effort aims to give Mexican patients access to proven, non-drug acne care.
Read Announcement- Drug:
- TheraClear®X
- Announced Date:
- July 17, 2024
- Indication:
- Treatment of acne
Announcement
STRATA Skin Sciences, Inc announces the publication of a clinical study titled, "Advancing precision acne therapy using a photopneumatic device," in the July 11, 2024 issue of the Journal of Cosmetic and Laser Therapy.
AI Summary
STRATA Skin Sciences, Inc. recently announced the publication of a clinical study titled "Advancing precision acne therapy using a photopneumatic device" in the July 11, 2024 issue of the Journal of Cosmetic and Laser Therapy. The study focused on its TheraClear®X device, showing it to be an effective treatment for patients with mild-to-moderate acne. Researchers found that the device, when used alone or with other treatments, helped reduce acne lesions, skin redness, and improved overall skin texture and pore size.
By allowing tailored treatment through adjustable pulse structure, pulse duration, vacuum pressure, and energy intensity, the TheraClear®X system offers precision therapy that matches individual skin types and acne severity. The study reported visible improvements after as few as three treatments with minimal side effects, making it a promising non-drug option for managing acne.
Read Announcement- Drug:
- TheraClear®X
- Announced Date:
- June 7, 2024
- Indication:
- Treatment of acne
Announcement
STRATA Skin Sciences 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). ,
AI Summary
STRATA Skin Sciences has published a clinical study in the June 2024 issue of the Journal of Clinical and Aesthetic Dermatology. The 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," evaluated six weekly treatments using the TheraClear®X Acne Therapy System. Led by Dr. Glynis Ablon, the research demonstrated that the photopneumatic device is a safe and effective treatment option for mild-to-moderate acne.
The study showed a significant reduction in acne lesion counts and notable improvements in global assessments and patient satisfaction scores, with visible improvements in as little as three treatments. Participants reported high levels of satisfaction, and the therapy was well tolerated with no treatment-related adverse events. These results further validate the benefits and safety of STRATA’s TheraClear®X system for acne management.
Read Announcement
XTRAC 308nm FDA Regulatory Events
XTRAC 308nm is a drug developed by Strata Skin Sciences for the following indication: Laser Treatment Combined with a Topical Drug in Psoriasis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XTRAC 308nm
- Announced Date:
- October 3, 2025
- Indication:
- Laser Treatment Combined with a Topical Drug in Psoriasis
Announcement
STRATA Skin Sciences, Inc highlights the substantial body of peer-reviewed clinical evidence supporting the XTRAC® Excimer Laser (308 nm) as a safe, highly effective treatment for localized atopic dermatitis, the most common form of eczema.
AI Summary
In recognition of Eczema Awareness Month, STRATA Skin Sciences, Inc. highlights a substantial body of peer-reviewed clinical evidence showing its XTRAC® Excimer Laser (308 nm) is a safe, highly effective treatment for localized atopic dermatitis, the most common form of eczema. Dermatologists value the therapy for its targeted approach, durability, and ability to spare healthy skin.
Key trials include Baltás et al. (2006), where patients saw an 81% drop in itching after one month with no serious side effects; Brenninkmeijer et al. (2010), which found results equal or superior to the steroid clobetasol propionate with longer-lasting improvement; and Shroff et al. (2016), reporting a 69% disease severity reduction, 87% achieving clear or almost clear skin, and remission averaging 11.3 months.
With the American Medical Association’s expanded indications for inflammatory and autoimmune skin diseases, Medicare, Medicaid, and private insurers now reimburse XTRAC treatments, improving access to this steroid-sparing option.
Read Announcement- Drug:
- XTRAC 308nm
- Announced Date:
- September 30, 2025
- Indication:
- Laser Treatment Combined with a Topical Drug in Psoriasis
Announcement
STRATA Skin Sciences, Inc. announces the publication of a new peer-reviewed study in Lasers in Medical Science that reinforces the Company's commitment to personalized medicine.
AI Summary
STRATA Skin Sciences published a peer-reviewed study in Lasers in Medical Science showing its XTRAC 308 nm Excimer Laser plus 0.1% tacrolimus ointment improves plaque psoriasis and highlights personalized medicine.
Researchers reviewed 100 adults treated from January 2023 to January 2024; one group used tacrolimus alone and the other added XTRAC laser with patient-specific dosing.
The combination group’s PASI score dropped from 18.36 to 3.30, compared to 18.62 to 5.23 in the control group (p < 0.01), showing a significant improvement.
No serious adverse events occurred. A few patients experienced mild, self-resolving irritation or eczema.
Personalized laser dosing based on MED and plaque features focused treatment on problem areas while sparing healthy skin.
Dr. Dolev Rafaeli, STRATA’s President and CEO, said this study underscores the XTRAC system’s safety, flexibility, and role in precision dermatology.
Read Announcement
