Evaluation of Candela Technology for Skin Treatments

Clinical Study to Evaluate the Safety and Efficacy of Candela Technology

This study is testing different Candela devices to see how well they can treat issues like hair removal, tattoo removal, wrinkles, acne, and scars for people who want to improve their skin.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Candela Corporation (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Jacksonville, Florida and 2 other locations)
• Trial ID: NCT06202274 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of various Candela Medical Technologies for treating conditions such as hair reduction, tattoo removal, wrinkles, acne, and scars. Participants may receive up to twelve treatments using different devices and techniques, including combination and sequential treatments. The study is non-randomized and open-label, allowing for flexibility in treatment approaches and follow-up evaluations. Participants will be monitored for treatment outcomes and may have follow-up visits either virtually or in person.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Fitzpatrick skin types I-VI who are seeking treatment for skin conditions addressed by Candela technologies.

Not a fit: Patients who are pregnant, breastfeeding, or have a history of skin cancer in the treatment area may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for various skin conditions, improving patient satisfaction and quality of life.

How similar studies have performed: Other studies have shown success with similar laser and light-based treatments for skin conditions, indicating a promising approach.

Eligibility criteria

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 requirements and pre and post treatment instructions.
5. Willing to receive clinical treatments with the study device to be utilized and comply with all study (protocol) requirements.
6. Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
7. 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.

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 12 months
4. Severe concurrent conditions, such as cardiac disorders, per investigator discretion
5. Impaired immune system or use of immunosuppressive medications as deemed inappropriate per investigator discretion
6. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
7. Pacemaker or internal defibrillator or any active electrical implant anywhere in the body if to be treated with an RF based device
8. 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
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 well as very thin or fragile skin as per discretion of the investigator
11. History of collagen vascular disease or vasculitic disorders as per discretion of the investigator
12. Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g. lidocaine)
13. History of systemic corticosteroid therapy in past six months as per discretion of the investigator
14. Tattoos or permanent makeup in the intended treatment area unless to be treated for tattoos or permanent makeup
15. 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.
16. 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.

Where this trial is running

Jacksonville, Florida and 2 other locations

• Center for Morden Aesthetic Medicine — Jacksonville, Florida, United States (Recruiting)
• Candela Institue for Excellence — Marlborough, Massachusetts, United States (Recruiting)
• Yokneam Candela Clinic — Yoqne'am 'Illit, Israel (Not_yet_recruiting)

Study contacts

• Principal investigator: Konika P Schallen, MD — Candela Institue for Exellence
• Study coordinator: Maya Duffy

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