Clinical Study to Evaluate the Safety and Efficacy of Candela Technology

Last updated: February 11, 2025
Sponsor: Candela Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Conditions

Skin Wounds

Acne

Treatment

Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RE

Clinical Study ID

NCT06202274
PM23001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 18 years of age or older

  2. Fitzpatrick skin type I-VI

  3. Willingness to provide signed, informed consent to participate in the study

  4. Able and willing to comply with the treatment/follow-up schedule and requirementsand pre and post treatment instructions.

  5. Willing to receive clinical treatments with the study device to be utilized andcomply with all study (protocol) requirements.

  6. Willingness to allow photographs and/or video of treated areas, and to release theiruse for scientific/educational and/or promotional/marketing purposes

  7. Willing to abstain from any other procedures, medications or topicals in the studytreatment areas for the duration of the study which the investigator deems wouldinterfere with the study.

Exclusion

Exclusion Criteria:

  1. Pregnant or planning to become pregnant, or breast feeding during the study

  2. Skin cancer in the treatment area or history of melanoma in the treatment area

  3. History of current cancer and subject has undergone chemotherapy within the last 12months

  4. Severe concurrent conditions, such as cardiac disorders, per investigator discretion

  5. Impaired immune system or use of immunosuppressive medications as deemedinappropriate per investigator discretion

  6. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following aprophylactic regimen

  7. Pacemaker or internal defibrillator or any active electrical implant anywhere in thebody if to be treated with an RF based device

  8. Superficial metal or other implants in the treatment area, except superficial dentalimplants, unless these implants can be removed or covered with rolled gauze duringtreatment if to be treated with an RF based device

  9. Active skin condition in the treatment area such as skin infection, sores,psoriasis, eczema, rash, or open wounds as per discretion of the investigator

  10. History of abnormal wound healing, keloid, or hypertrophic scar formation, as wellas very thin or fragile skin as per discretion of the investigator

  11. History of collagen vascular disease or vasculitic disorders as per discretion ofthe investigator

  12. Known allergy to medication to be used during treatments such as allergy to topicalanesthetic (e.g. lidocaine)

  13. History of systemic corticosteroid therapy in past six months as per discretion ofthe investigator

  14. Tattoos or permanent makeup in the intended treatment area unless to be treated fortattoos or permanent makeup

  15. If to be treated for efficacy assessments, history of aestheticstreatments/procedures (e.g. facial resurfacing and deep chemical peeling) within thelast 4 months within the intended treatment area, neuromodulator injections (e.g.Botox®), collagen, non-permanent dermal filler, or fat injections or other methodsof augmentation with injected bio-material in the treated area within the last 3months, permanent synthetic fillers (e.g. silicone) in the treatment area,absorbable facial threads within the last 1 year or non-absorbable facial threadswithin the intended treatment area, or surgery within the intended treatment area.History of prior treatments and procedures will be assessed per investigatordiscretion.

  16. In the opinion of the investigator, the subject is unwilling or unable to adhere tothe study requirements or is otherwise unsuitable for the study.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RE
Phase:
Study Start date:
October 04, 2023
Estimated Completion Date:
October 04, 2029

Study Description

Subjects may receive treatment with one applicator or combination of any of the devices and applicators and/or additional commercial devices, products, and procedures. Evaluations may include combination treatments, sequential treatments, split face treatments, exploration of treatment and system parameters, and evaluation of exploratory indications. Treatments may include evaluation of commercial Candela systems with modification in hardware or software and/or treatment outside of treatment guidelines and exploratory indications (off-label) for evaluation of clinical feedback, device components, and treatment outcomes.

Subjects may receive up to twelve (12) treatments. Treatments may occur with a minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks. The number and interval of treatments will depend upon the device(s), treatment area, and indication to be treated. Follow-up visits may be required per PI discretion. Follow-up visits may occur virtually or in person.

Connect with a study center

  • Yokneam Candela Clinic

    Yoqne'am 'Illit, 20692
    Israel

    Site Not Available

  • Center for Morden Aesthetic Medicine

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Candela Institue for Excellence

    Marlborough, Massachusetts 01752
    United States

    Active - Recruiting

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