Candela Technology for Skin Conditions
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byKonika P Schallen, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Candela Corporation
Must not be taking: Immunosuppressants, Corticosteroids
Disqualifiers: Pregnancy, Skin cancer, Cardiac disorders, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.
Will I have to stop taking my current medications?
The trial requires participants to avoid any other procedures, medications, or topical treatments in the study treatment areas if they might interfere with the study. It's best to discuss your current medications with the study team to see if they might be affected.
What data supports the effectiveness of the treatment Candela Technology for skin conditions?
Research on light-emitting diode phototherapy (LED-LLLT), which is similar to Candela Technology, shows it can help heal wounds faster, reduce pain and inflammation, and improve skin conditions like acne. This suggests that Candela Technology might also be effective for treating skin conditions.
12345Is Candela Technology generally safe for use in humans?
The available research does not provide specific safety data for Candela Technology or its related products. However, general safety evaluations for dermatology treatments often involve clinical trials and post-marketing surveillance to monitor adverse reactions and ensure consumer safety.
678910How does Candela Technology treatment differ from other treatments for skin conditions?
Candela Technology is unique because it uses light-emitting diode (LED) therapy, which is a nonthermal light treatment that can safely address various skin conditions like inflammation and aging. This approach is different from traditional methods like UV lamps, which can be harmful, as LED therapy is considered safer and has become a common practice among dermatologists.
1112131415Eligibility Criteria
Adults over 18 with any skin type can join this study if they're willing to follow the treatment plan, allow photos for research and marketing, and avoid other treatments in the area during the study. Pregnant or breastfeeding individuals, those with recent cancer treatments, severe health conditions, impaired immune systems, certain implants or active skin issues are excluded.Inclusion Criteria
Willingness to provide signed, informed consent to participate in the study
Willing to receive clinical treatments with the study device to be utilized and comply with all study (protocol) requirements
Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
+4 more
Exclusion Criteria
Impaired immune system or use of immunosuppressive medications as deemed inappropriate per investigator discretion
In the opinion of the investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for the study
I haven't had any facial aesthetic treatments in the required time frame before joining.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Subjects may receive up to twelve treatments with Candela Medical Technology, with intervals between treatments ranging from 2 to 12 weeks.
Up to 132 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up visits may occur virtually or in person.
Participant Groups
The trial is testing Candela Medical Technology devices like Nordlys and Vbeam on various skin conditions including hemangioma and acne. It's an open-label study where everyone knows what treatment they're getting. Participants will be treated at multiple centers.
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment will be performed with commercial products manufactured by Candela and may also include non-Candela products. All devices will be used per the manufacturer's instructions.
Candela Technology is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Candela Medical Technology for:
- General dermatological procedures
- Facial wrinkle reduction
- Skin tightening
- Skin rejuvenation
🇪🇺 Approved in European Union as Candela Medical Technology for:
- General dermatological procedures
- Facial wrinkle reduction
- Skin tightening
- Skin rejuvenation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Candela Institue for ExcellenceMarlborough, MA
Center for Morden Aesthetic MedicineJacksonville, FL
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Who Is Running the Clinical Trial?
Candela CorporationLead Sponsor
References
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Is light-emitting diode phototherapy (LED-LLLT) really effective? [2022]Low level light therapy (LLLT) has attracted attention in many clinical fields with a new generation of light-emitting diodes (LEDs) which can irradiate large targets. To pain control, the first main application of LLLT, have been added LED-LLLT in the accelerated healing of wounds, both traumatic and iatrogenic, inflammatory acne and the patient-driven application of skin rejuvenation. Rationale and Applications: The rationale behind LED-LLLT is underpinned by the reported efficacy of LED-LLLT at a cellular and subcellular level, particularly for the 633 nm and 830 nm wavelengths, and evidence for this is presented. Improved blood flow and neovascularization are associated with 830 nm. A large variety of cytokines, chemokines and macromolecules can be induced by LED phototherapy. Among the clinical applications, non-healing wounds can be healed through restoring the collagenesis/collagenase imbalance in such examples, and 'normal' wounds heal faster and better. Pain, including postoperative pain, postoperative edema and many types of inflammation can be significantly reduced. Experimental and clinical evidence: Some personal examples of evidence are offered by the first author, including controlled animal models demonstrating the systemic effect of 830 nm LED-LLLT on wound healing and on induced inflammation. Human patients are presented to illustrate the efficacy of LED phototherapy on treatment-resistant inflammatory disorders.
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How is safety of dermatology drugs assessed: trials, registries, and spontaneous reporting. [2021]Introduction: Skin conditions are common and highly varied in their etiology; therefore, a diverse array of therapeutics are utilized. Drug safety studies in dermatology can be challenging as there are over 3000 diagnoses to consider. As a result, dermatologists rely on data from multiple sources including clinical trials and real-world evidence.Areas covered: In this review, we cover the main sources of safety data available, their strengths and weaknesses and how dermatologists should utilize such data. We use real-world examples of the different types of adverse events reported and how they are best captured by either randomized controlled trials or post-marketing pharmacovigilance methods. With multiple new therapies in dermatology, such as dupilumab for atopic dermatitis and janus-kinase inhibitors for alopecia areata the specialty is awash with evolving high-level evidence for their use. It is important to understand the optimal way to assess safety from trials but also appreciate the need for ongoing capture of safety data in clinical practice.Expert opinion: In dermatology, there is a plethora of conditions to treat and clinical trials, post-marketing surveillance, such as drug registries and spontaneous reporting, all enable dermatologists to gain a more comprehensive understanding of the safety profiles of drugs being used.
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Usability Validation of Medical Devices: Issues in Identifying Potential Use Errors. [2018]In order to prevent use errors with their medical devices, manufacturers have to integrate a safety-oriented usability engineering process in their product development lifecycle. A critical step of this process is the identification of potential use-errors. Standards and guidelines recommend to triangulate several sources of information e.g. scientific literature, incident reports, manufacturer's files and user's feedbacks. This paper presents lessons learned from applying these recommendations during an international project. We identify issues with (i) searching literature and databases, and (ii) interpreting collected data. Nevertheless triangulation of information sources allows to identify different types of use errors therefore providing valuable lists of potential use errors. Issuing recommendations aim at making easier this critical task.
[Incoherent light in dermatology]. [2021]In the everyday practice of dermatology, we encounter light in many ways. The biological and physical interactions between light and skin make light a potent diagnostic and therapeutic tool when well directed. This contribution intends to illuminate the possible uses of light-emitting diodes and high-energy flashlamps in dermatology. Both sources of light have only recently been employed in dermatology and in addition to broadband ultraviolet (UV) light sources, high-pressure gas discharge lamps, and halogen lamps enrich the armamentarium of incoherent light sources.
[Smart skin-A new technology in the area of digital dermatology]. [2022]Numerous developments in the field of digital medicine have helped to improve the treatment and management of diseases. Smart skin is one promising technology. Through sensors that are attached to the skin, a wide variety of physiological parameters can be measured, e.g., concentration of hormones, presence of inflammation markers, or the glucose level. As this technology can be applied to different parts of the body, information about various organ systems can be obtained. In the case of diabetes, research is already very advanced due to its endemic relevance and the need for long-term treatment. For example, invasive blood measurement can be replaced by implantable tattoos which react to a change in the glucose level by changing its color. In the context of type 1 diabetes, a closed-loop control circuit can be created with so-called microneedling, which results in independent insulin delivery when blood glucose levels are too high. Moreover, there are also smart skin innovations for the management of chronic wounds. With the continuous measurement of physiological indicators such as pH, temperature, or bacterial milieu, the condition of the wound can be observed. The basic principles of the smart skin technology can be transferred into many areas in the field of dermatological care and, therefore, also represent a relevant aspect for dermatologists in the care of their patients. Continuous developments in the field of smart skin technologies show high potential for further research in a wide range of specialties with the aim to facilitate everyday clinical life for patients and physicians.
Photodynamic and photobiological effects of light-emitting diode (LED) therapy in dermatological disease: an update. [2019]Benefit deriving from the use of light is known since ancient time, but, only in the last decades of twentieth century, we witnessed the rapid expansion of knowledge and techniques. Light-emitted diode (LED)-based devices represent the emerging and safest tool for the treatment of many conditions such as skin inflammatory conditions, aging, and disorders linked to hair growth. The present work reviews the current knowledge about LED-based therapeutic approaches in different skin and hair disorders. LED therapy represents the emerging and safest tool for the treatment of many conditions such as skin inflammatory conditions, aging, and disorders linked to hair growth. The use of LED in the treatment of such conditions has now entered common practice among dermatologists. Additional controlled studies are still needed to corroborate the efficacy of such kind of treatment.
Light-emitting diodes (LEDs) in dermatology. [2022]Light-emitting diode photobiomodulation is the newest category of nonthermal light therapies to find its way to the dermatologic armamentarium. In this article, we briefly review the literature on the development of this technology, its evolution within esthetic and medical dermatology, and provide practical and technical considerations for use in various conditions. This article also focuses on the specific cell-signaling pathways involved and how the mechanisms at play can be put to use to treat a variety of cutaneous problems as a stand-alone application and/or complementary treatment modality or as one of the best photodynamic therapy light source.
Noninvasive treatment of psoriasis and skin rejuvenation using an akermanite-type narrowband emitting phosphor. [2023]Psoriasis is a noncontagious, long-lasting skin infection that affects many people around the world. Numerous therapeutic artificial treatments are available for the treatment of psoriasis, such as photodynamic therapy using broadband ultraviolet (UV) lamps, which have harmful effects on human skin. Similarly, the natural healing systems such as sunlight have a higher risk of sunburn and can cause dangerous forms of skin cancer. Significant light emission of a specific wavelength (in the UV range), and phosphor-based devices demonstrate the effectiveness of treating psoriasis without damaging the skin. Gd3+ -doped calcium magnesium silicate [Ca2 MgSi2 O7 :Gd3+ ,(CMS:Gd3+ )] phosphor is one of the ideal phosphors that emit specific narrow UV wavelengths for curing psoriasis and is in great demand in the field of dermatology. Photoluminescence analysis at room temperature (~25°C) shows that the synthesized CMS:Gd3+ phosphor emits narrowband UV-B light with a peak intensity at 314 nm. Comparative studies of the standard action spectrum of psoriasis with the emission spectrum of the CMS:Gd3+ phosphor show that the synthesized phosphor was the most suitable material for treating a variety of diseases, including psoriasis, vitiligo, type-1 diabetes, dental disease, sleep and mood disorders, and other skin diseases.