FDA Events for Strata Skin Sciences (SSKN)
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. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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
Strata Skin Sciences FDA Events - Frequently Asked Questions
As of now, Strata Skin Sciences (SSKN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Strata Skin Sciences (SSKN) has reported FDA regulatory activity for TheraClear®X.
The most recent FDA-related event for Strata Skin Sciences occurred on July 17, 2024, involving TheraClear®X. The update was categorized as "Publication," with the company reporting: "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."
Currently, Strata Skin Sciences has one therapy (TheraClear®X) targeting the following condition: Treatment of acne.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:SSKN) was last updated on 7/13/2025 by MarketBeat.com Staff
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