Clinical Study to Evaluate the Safety and Efficacy of Candela Technology

Launched by CANDELA CORPORATION · Jan 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a new technology from Candela, which is designed to help with various skin treatments like hair removal, tattoo removal, reducing wrinkles, acne scars, and other skin conditions. The trial is currently recruiting participants who are at least 18 years old and have specific skin types. To be eligible, you'll need to be able to follow treatment instructions, consent to participate, and agree to have photos taken during the study.

If you join the study, you'll receive treatments using the Candela technology, and you'll be asked to attend follow-up appointments. It's important to note that certain health conditions, like a history of skin cancer or severe heart problems, may make you ineligible to participate. Participants will need to avoid other skin treatments in the areas being treated during the study. Overall, this trial aims to gather valuable information to help improve skin treatments for everyone.

Gender

ALL

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.