Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening

The objective of this investigation is to evaluate the effectiveness of a non-ablative treatment for skin laxity by increasing dermatofibrosis of the reticular dermis using the Candela GentleYAG laser. Treatment areas will be limited to the thighs.

• The primary objective is to assess the safety and efficacy of the laser for improvement in appearance of cellulite.
• The secondary objective is to assess the safety and efficacy of the laser with cooling and the laser without cooling for improvement in appearance of cellulite.

This is an open label trial. Treatment will be conducted on either the left or the right thigh, which will be randomly determined. The contra-lateral side will not be treated and will serve as a control. A comparison of baseline photographs (prior to treatments) to photographs taken 1 and 3 months after the completion of treatments will be conducted. Photographic equipment and the protocol for photography will be consistent at each visit. Ultrasound may be taken at baseline and at the follow-up visits to evaluate flatness of cellulite and dermal fibrosis or enlargement of the reticular dermis. The circumference of the area to be treated will be measured with a tape measure, weight/height will be recorded and the Body Mass Index (BMI) will be calculated at baseline and follow-up visits. In addition, skin elasticity may be measured at the treatment areas at baseline and follow-up visits. The photographs, ultrasound and measurements will be taken using consistent procedures at each visit by viewing the baseline photograph and using landmarks such as freckles and birthmarks.

Inclusion criteria

• Individuals, male or female, greater than 40 years of age.
• Moderate skin laxity in the arms, legs, abdomen, or neck.
• Subject is not overweight. Body Mass Index (B.M.I.) is ≤ 27.
• Subject has Fitzpatrick skin phototype I-IV.
• Subject is willing to participate in study and adhere to follow-up schedule.
• Subject is able to read and comprehend English.
• Subject has completed Informed Consent Form.

Exclusion criteria

• Subjects that have had liposuction or other surgical procedures (including mesotherapy) to remove fat in the treatment area during the past year.
• Subject is overweight (BMI > 27).
• Subject has known photosensitivity or history of ingesting medications known to induce photosensitivity in the previous 3 months.
• Subject has a personal or family history of keloid formation or scarring.
• Subject is pregnant or lactating.
• Subject has a history of uncontrolled diabetes and/or requires medication which may interfere with the study.
• Subjects with a known history of neuropathy.
• Subjects with a known history of a coagulopathy.
• Subject is unable or unwilling to comply with the study requirements
• Subject has pacemaker or metallic implants.
• Subject has Fitzpatrick skin type V and VI.
• Subject is mentally incompetent or a prisoner.