Candela Technology for Skin Conditions

Recruiting at 2 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

500 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{11 12 13 14 15}

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.

Research Team

Konika P Schallen, MD

Principal Investigator

Candela Institue for Exellence

Eligibility 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

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

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Use of technomolecular silver preparations in complex treatment of infected wounds. [2020]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Cutaneous laser surgery. An update. [2007]

4. Japan pubmed.ncbi.nlm.nih.gov

Is light-emitting diode phototherapy (LED-LLLT) really effective? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

What's New in Pigmentary Disorders. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Indoor tanning injuries: an evaluation of FDA adverse event reporting data. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Surveillance of dermo-cosmetic products: a global cosmetovigilance system to optimise product development and consumer safety. [2021]

8. England pubmed.ncbi.nlm.nih.gov

How is safety of dermatology drugs assessed: trials, registries, and spontaneous reporting. [2021]

9. France pubmed.ncbi.nlm.nih.gov

[Clinical trials in dermatology. The phase I trials]. [2013]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Usability Validation of Medical Devices: Issues in Identifying Potential Use Errors. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

[Incoherent light in dermatology]. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

[Smart skin-A new technology in the area of digital dermatology]. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Photodynamic and photobiological effects of light-emitting diode (LED) therapy in dermatological disease: an update. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

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

15. England pubmed.ncbi.nlm.nih.gov

Noninvasive treatment of psoriasis and skin rejuvenation using an akermanite-type narrowband emitting phosphor. [2023]