Candela Technology for Skin Conditions

Not currently recruiting at 3 trial locations

Overseen By Katherine Coleman, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Candela Corporation

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pregnancy, Skin cancer, Cardiac disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 132 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a treatment using Candela Technology for various skin conditions. Participants will receive treatments with devices made by Candela, and possibly other non-Candela products, to evaluate their effectiveness. Ideal participants have any skin type and are willing to follow study guidelines, including allowing photos of treated areas. The trial excludes individuals with skin cancer in the treatment area, a history of certain skin conditions, or those who have recently undergone specific aesthetic treatments. As an unphased trial, this study provides a unique opportunity to explore innovative treatments and contribute to advancing skin care solutions.

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 prior data suggests that Candela Technology is safe for treating skin conditions?

Research has shown that Candela Technology is generally safe for skin treatments. The Candela GentleLASE GL Dermatology Laser is approved for treating skin issues like vascular lesions, indicating it has passed safety checks for these uses.

The equipment is designed for safe use according to the manufacturer's instructions. Although specific data on side effects in this study is unavailable, the technology's approval for similar treatments suggests that serious side effects are rare. However, like any treatment, some individuals might experience mild side effects such as redness or swelling.

Prospective trial participants should discuss any concerns with the study team, who can provide more details about what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Candela Technology for skin conditions because it offers a novel approach to treatment using advanced devices that may combine both Candela and non-Candela products. Unlike traditional therapies that might rely on topical creams or invasive procedures, Candela Technology utilizes cutting-edge devices that are used according to precise manufacturer instructions, potentially enhancing safety and efficacy. This method could provide more targeted treatment, reducing side effects and improving outcomes for patients with various skin conditions.

What evidence suggests that Candela Technology is effective for skin conditions?

Research has shown that Candela Technology effectively treats various skin conditions using devices like lasers. In this trial, commercial products manufactured by Candela will treat skin issues such as cellulite and other cosmetic concerns. Candela's devices are non-ablative, meaning they work without removing skin layers, allowing for quicker recovery. Patients have reported noticeable improvements and high satisfaction due to its use of multiple technologies. Overall, Candela Technology has demonstrated promising results for improving skin appearance and addressing a range of skin concerns. ^{3 4 6 7 8}

Who Is on the Research Team?

Konika P Schallen, MD

Principal Investigator

Candela Institue for Exellence

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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.

What Are the Treatments Tested in This Trial?

Interventions

• Candela Technology

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Candela Corporation

Lead Sponsor

Trials

22

Recruited

2,200+

Published Research Related to This Trial

Light-emitting diodes (LEDs) and high-energy flashlamps are emerging tools in dermatology, enhancing diagnostic and therapeutic options for skin conditions.

These light sources, along with traditional UV and halogen lamps, expand the range of incoherent light therapies available to dermatologists, potentially improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Incoherent light in dermatology]. Babilas, P., Schreml, S., Landthaler, M., et al.[2021]

In a study involving 29 patients with infected wounds, the use of local combination drugs containing techno-molecular silver, specifically 'Cadefort-Spray', showed high effectiveness in treating the wounds.

The treatment accelerated wound healing, stimulated regeneration, and enhanced local adaptive immunity, while also preventing atopic reactions, regardless of the wound's healing phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of technomolecular silver preparations in complex treatment of infected wounds. Filip, SS., Slivka, RM., Skripinets, YP., et al.[2020]

Low level light therapy (LLLT) using specific wavelengths of LED light (633 nm and 830 nm) has been shown to effectively enhance wound healing and reduce pain and inflammation, supported by both animal and human studies.

LED-LLLT can significantly improve outcomes for non-healing wounds and accelerate healing in normal wounds, making it a promising adjunct treatment alongside traditional surgical and nonsurgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is light-emitting diode phototherapy (LED-LLLT) really effective? Kim, WS., Calderhead, RG.[2022]

Dermatologists face challenges in assessing drug safety due to the vast number of skin conditions (over 3000 diagnoses), necessitating the use of diverse data sources including clinical trials and real-world evidence.

New therapies like dupilumab for atopic dermatitis and Janus-kinase inhibitors for alopecia areata are supported by evolving high-level evidence, highlighting the importance of both trial data and ongoing safety monitoring in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How is safety of dermatology drugs assessed: trials, registries, and spontaneous reporting. Asfour, L., Yiu, ZZN., Warren, RB.[2021]

Smart skin technology, which uses sensors to measure various physiological parameters, shows great promise in managing diseases like diabetes by providing real-time data on glucose levels and other indicators.

Innovations such as implantable tattoos for glucose monitoring and smart skin for chronic wound management highlight the potential of this technology to improve patient care and facilitate clinical practices across multiple medical specialties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Smart skin-A new technology in the area of digital dermatology]. Kiani, C., Steiner, C., Zink, A.[2022]

Light-emitting diode (LED) photobiomodulation is a new nonthermal light therapy that has been integrated into dermatology for treating various skin conditions.

The article discusses the specific cell-signaling pathways involved in LED therapy, highlighting its potential as both a standalone treatment and a complementary option in photodynamic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light-emitting diodes (LEDs) in dermatology. Barolet, D.[2022]

The Juxta CURES compression device has been shown to improve patients' quality of life by enhancing healing rates and reducing recurrence rates of wounds.

This device not only benefits patients by supporting their physical and emotional needs but also helps clinicians achieve better outcomes while maintaining cost efficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Juxta CURES: compression for healing venous leg ulcers. Nugent, L.[2014]

New laser technologies, while not a cure-all, have significantly improved treatment options for various medical conditions by utilizing different wavelengths of light and innovative delivery systems.

The ongoing advancements in laser therapy are expected to enhance treatment effectiveness for a growing range of skin disorders, offering hope for patients who previously had limited options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous laser surgery. An update. Wheeland, RG.[2007]

There is a significant need for standardized therapies for common pigmentary disorders like vitiligo, melasma, and postinflammatory hyperpigmentation, as current treatment options are often based on smaller studies rather than large-scale trials.

The review highlights various treatment modalities, including topical, systemic, light, and laser therapies, which show promise but require further investigation through well-designed randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's New in Pigmentary Disorders. Zubair, R., Lyons, AB., Vellaichamy, G., et al.[2019]

LED-based devices are emerging as safe and effective tools for treating various skin and hair disorders, including inflammation and aging.

Despite their growing use in dermatology, more controlled studies are necessary to further confirm the efficacy of LED therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic and photobiological effects of light-emitting diode (LED) therapy in dermatological disease: an update. Sorbellini, E., Rucco, M., Rinaldi, F.[2019]

The Gd3+-doped calcium magnesium silicate (CMS:Gd3+) phosphor emits narrowband UV-B light at 314 nm, making it a promising treatment for psoriasis without the harmful effects associated with traditional UV therapies.

This phosphor not only shows effectiveness in treating psoriasis but also has potential applications for other conditions like vitiligo, type-1 diabetes, and mood disorders, highlighting its versatility in dermatological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive treatment of psoriasis and skin rejuvenation using an akermanite-type narrowband emitting phosphor. Sharma, AA., Rakshita, M., Pradhan, PP., et al.[2023]

Before using a new topical product on diseased skin, it is crucial to first assess its safety on healthy skin in human volunteers.

The paper outlines guidelines for evaluating potential skin irritation, sensitization, phototoxicity, and photoallergy of topical products, emphasizing the need for a structured safety evaluation approach since current studies lack regulatory oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical trials in dermatology. The phase I trials]. Czernielewski, J., Queille-Roussel, C., Duteil, L., et al.[2013]

From 1985 to 2006, about 50% of reported injuries from indoor tanning were due to UV exposure, but only a small number (less than 1 per year) resulted in hospitalization, indicating that while injuries can occur, they are often not severe.

The decline in reported UV-related injuries after 1996 suggests that adherence to FDA guidelines and improved training for tanning industry professionals could significantly enhance safety and reduce incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indoor tanning injuries: an evaluation of FDA adverse event reporting data. Dowdy, JC., Sayre, RM., Shepherd, JG.[2022]

Manufacturers of cosmetic products are responsible for ensuring compliance with safety regulations, and a structured global cosmetovigilance system is in place to monitor adverse reactions both during clinical development and after commercialization.

The system includes calculating a cosmetovigilance index (CVI) for each product, which helps identify safety signals and improve future formulations by focusing on the best tolerated products based on consumer feedback and adverse reaction data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surveillance of dermo-cosmetic products: a global cosmetovigilance system to optimise product development and consumer safety. Ribet, V., Albinet Claudin, L., Brinio, E., et al.[2021]

Integrating a safety-oriented usability engineering process is essential for medical device manufacturers to prevent use errors, highlighting the importance of identifying potential use errors during product development.

Triangulating multiple information sources, such as scientific literature and user feedback, is effective in uncovering various types of use errors, although challenges exist in searching and interpreting data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Validation of Medical Devices: Issues in Identifying Potential Use Errors. Schiro, J., Pelayo, S., Weinhold, T., et al.[2018]

Citations

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Candela Technology for Skin Conditions · Info for Participants 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.

2. trialx.com trialx.com/clinical-trials/listings/248987/clinical-study-to-evaluate-the-safety-and-efficacy-of-candela-technology/

Clinical Study to Evaluate the Safety and Efficacy of ... Overview. This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.

3. candelamedical.com candelamedical.com/

Candela Medical | Medical Aesthetic and Cosmetic Laser ... Candela Medical is a leader in medical aesthetic and cosmetic lasers, a respected US-based manufacturer of other energy-based equipment such as intense ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00585715

Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin ... The purpose of this research study is to evaluate effectiveness of a non-ablative (does not remove skin) treatment for cellulite (dimpled fat) in conjunction ...

5. candelamedical.com candelamedical.com/resources/aesthetic-blogs/smarter-skin-renewal-for-smarter-practices/

Intelligent Skin Renewal for Modern Practices Matrix's multi-technology approach delivers superior, visible outcomes across a wide range of skin concerns, enhancing patient satisfaction and ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/k994260.pdf

510(k) Summary - accessdata.fda.gov The Candela GentleLASE GL Dermatology Laser is indicated for the following uses: 1. 2. 3. The Photocoagulation of Dermatological vascular lesions.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240070.pdf

July 1, 2024 Candela Corporation Rina Ordonez Sr ... The Matrix Pro applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis. The. Matrix Pro applicator ...

8. candelamedical.com candelamedical.com/products/portfolio/

Product Portfolio Candela technologies provide aesthetic solutions for both the face and body. Our commitment to science-based innovation, consistent patient outcomes and trusted ...