Clinical Study to Evaluate the Safety and Efficacy of Candela Technology

NCT06202274 | Active Not Recruiting FDA Device

• 1 other identifier: PM23001
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Hair Reduction; Tattoo Removal; Wrinkle; Acne; Scars; Benign Cutaneous Vascular Lesions; Skin Conditions

Outcome Measures

Primary Outcomes (2)

• Numerical Rating Scale (NRS)

  Subject assessment of treatment discomfort/pain immediately post-treatment via Numerical Rating Scale (NRS). Subjects will be presented a horizontal line scale and asked to make a mark along the scale. Subjects will be asked to rate pain from 0 to 10, with 0 equaling no pain and 10 equaling the worst possible pain. A number is obtained by measuring up to the point the participant has indicated.

  From the first treatment to the last treatment, up 132 weeks.

• Post-treatment Assessment Severity Scale

  Skin responses including edema, erythema, pinpoint bleeding, purpura/ecchymosis, petechiae, and microscopic epithelial necrotic debris (MENDs) will be assessed immediately after treatment with a post-treatment assessment severity scale: grade 1 means absent, grade 2 means mild, grade 3 means moderate, and grade 3 means severe.

  From the first treatment to the last treatment, up to 132 weeks.

Study Arms (1)

Treatment

EXPERIMENTAL

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.

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

Interventions

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

Subjects will receive up to twelve (12) treatments at minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age or older
• Fitzpatrick skin type I-VI
• Willingness to provide signed, informed consent to participate in the study
• Able and willing to comply with the treatment/follow-up schedule and requirements and pre and post treatment instructions.
• 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
• Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study.

You may not qualify if:

• Pregnant or planning to become pregnant, or breast feeding during the study
• Skin cancer in the treatment area or history of melanoma in the treatment area
• History of current cancer and subject has undergone chemotherapy within the last 12 months
• Severe concurrent conditions, such as cardiac disorders, per investigator discretion
• Impaired immune system or use of immunosuppressive medications as deemed inappropriate per investigator discretion
• Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
• Pacemaker or internal defibrillator or any active electrical implant anywhere in the body if to be treated with an RF based device
• Superficial metal or other implants in the treatment area, except superficial dental implants, unless these implants can be removed or covered with rolled gauze during treatment if to be treated with an RF based device
• Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds as per discretion of the investigator
• History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin as per discretion of the investigator
• History of collagen vascular disease or vasculitic disorders as per discretion of the investigator
• Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g. lidocaine)
• History of systemic corticosteroid therapy in past six months as per discretion of the investigator
• Tattoos or permanent makeup in the intended treatment area unless to be treated for tattoos or permanent makeup
• If to be treated for efficacy assessments, history of aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area, neuromodulator injections (e.g. Botox®), collagen, non-permanent dermal filler, or fat injections or other methods of augmentation with injected bio-material in the treated area within the last 3 months, permanent synthetic fillers (e.g. silicone) in the treatment area, absorbable facial threads within the last 1 year or non-absorbable facial threads within the intended treatment area, or surgery within the intended treatment area. History of prior treatments and procedures will be assessed per investigator discretion.

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (3)

Center for Morden Aesthetic Medicine

Jacksonville, Florida, 32207, United States

Location

Candela Institue for Excellence

Marlborough, Massachusetts, 01752, United States

Location

Yokneam Candela Clinic

Yokneam Illit, 20692, Israel

Location

MeSH Terms

Conditions

Acne Vulgaris; Cicatrix; Skin Diseases

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Konika P Schallen, MD

  Candela Institue for Exellence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: October 4, 2023
• Primary Completion (Estimated): October 4, 2028
• Study Completion (Estimated): October 4, 2029
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (2); IL (1)