On December 5, 2025, an important milestone was reached in the field of scar management. A completed clinical trial evaluated the effectiveness of two treatment approaches for hypertrophic and keloid scars. The trial compared intralesional corticosteroid injections alone with a combined approach incorporating laser therapy using the Fotona Dynamis system. Somdech Phra Nangchao Sirikit Hospital conducted this study, shedding light on innovative integrations of drug and device-based management.
This update holds significance for clinical, quality, and regulatory teams monitoring advancements in medical device applications. Insights from this study will influence both performance evaluations and patient therapy plans in the domain of dermatology and wound healing.
What were the study methods?
The trial investigated two therapeutic pathways for hypertrophic and keloid scars:
- Drug: Triamcinolone acetonide injection, a widely utilized corticosteroid in dermatology.
- Device: Fotona Dynamis system combining long pulse Nd:YAG laser and Er:YAG laser for tissue modulation and remodeling.
Participants received either intralesional corticosteroid injections or the combination of injections with laser technology. Researchers aimed to assess and compare the clinical outcomes, safety profiles, and overall effectiveness across these groups. Detailed protocols ensured adherence to regulatory standards and compliance benchmarks.
Key findings of the trial
While specific clinical data is yet to be widely disseminated, the trial’s design contributes to regulatory and clinical discussions on combination approaches in scar management. Combining lasers with corticosteroid injections may enhance collagen remodeling and reduce scar tissue thickness more significantly than corticosteroids alone. The inclusion of the Fotona Dynamis system represents an advancement in procedural options for complex dermatological concerns.
Quality teams focused on healthcare device performance and therapy efficiencies should interpret these findings in conjunction with existing safety and efficacy reports. The study may prompt upcoming adjustments to therapeutic guidelines and recommend broader adoption for cases with poor results from single-modality approaches.
FAQ about the trial
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What conditions were studied?
Hypertrophic scars and keloids. These abnormal scars result from excessive collagen deposition during wound healing. -
What devices were used?
The Fotona Dynamis system featuring long pulse Nd:YAG and Er:YAG lasers. -
Where was the trial conducted?
Somdech Phra Nangchao Sirikit Hospital led the study. -
Why is this trial significant?
It explores combining therapies to optimize scar treatment outcomes in patients where conventional pathways fail.
Implications for clinical practice
These findings encourage healthcare providers and regulatory teams to revisit therapeutic protocols for managing hypertrophic and keloid scars. Advanced device-integrated methods like laser-assisted drug deliveries may redefine clinical outcomes and streamline patient recovery trajectories. It reinforces the importance of multidisciplinary collaboration in dermatology.
Quality teams should monitor for upcoming publications that detail the procedural advantages and potential for scaling within different hospital settings.
Important disclaimer
This content is provided for informational purposes only and does not constitute medical or legal advice. Regulatory decisions and clinical applications should align with official guidance and direct evidence-based evaluations.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07263100?term=medical+device