Trial Outcomes & Findings for Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening (NCT NCT00585715)

Results Overview

Nurnberger-Muller Scale : Stage 0: No dimpling. Stage 1: No dimpling. Stage 2: Dimpling spontaneously standing. Stage 3: Dimpling spontaneously standing and lying down. Texture Scale: Hard or Solid: Pinch test "firm folds and furrows." Adherent to deep planes. Not modified with lying versus standing position. Soft or Flaccid: Pinch test "spongy and floating folds and furrows." No adherence to deep planes. Not painful, flaccid. "Orange peel skin" appears spontaneously. Edematous: Doughy consistency. Pain and cramps. Signs of venous and lymphatic insufficiency "legs in boot/column". At the 6month follow-up, a blinded assessor ranked changes in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as "no change" and 3 as "significant change." Improvement in cellulite appearance was characterized by an increase of one unit or more on this scale.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

6 month follow up

Results posted on

2022-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Laser With Cooling Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.	Laser Without Cooling Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
Overall Study STARTED	11	11
Overall Study COMPLETED	8	11
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laser With Cooling n=11 Participants Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.	Laser Without Cooling n=11 Participants Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38 years STANDARD_DEVIATION 9.47724547 • n=5 Participants	36 years STANDARD_DEVIATION 8.40346249 • n=7 Participants	37 years STANDARD_DEVIATION 8.77225062 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month follow up

Population: Only subjects who completed the 6 month follow-up were included in the analysis

Nurnberger-Muller Scale : Stage 0: No dimpling. Stage 1: No dimpling. Stage 2: Dimpling spontaneously standing. Stage 3: Dimpling spontaneously standing and lying down. Texture Scale: Hard or Solid: Pinch test "firm folds and furrows." Adherent to deep planes. Not modified with lying versus standing position. Soft or Flaccid: Pinch test "spongy and floating folds and furrows." No adherence to deep planes. Not painful, flaccid. "Orange peel skin" appears spontaneously. Edematous: Doughy consistency. Pain and cramps. Signs of venous and lymphatic insufficiency "legs in boot/column". At the 6month follow-up, a blinded assessor ranked changes in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as "no change" and 3 as "significant change." Improvement in cellulite appearance was characterized by an increase of one unit or more on this scale.

Outcome measures

Outcome measures
Measure	Laser With Cooling for Skin Tightening n=7 Participants Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.	Laser Without Cooling for Skin Tightening n=9 Participants Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
Number of Participants With Mild to Moderate Reduction in Cellulite.	3 participants	2 participants

PRIMARY outcome

Timeframe: 6 month follow up

Population: The average amount of cellulite reduction was calculated from the 5 subjects who experienced mild to moderate improvement in cellulite appearance.

At the 6 month follow-up, a blinded assessor ranked change in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as "no change" and 3 as "significant change." Using this scale, the average reduction in cellulite appearance was calculated for each participant that experienced a mild to moderate reduction in cellulite appearance.

Outcome measures

Outcome measures
Measure	Laser With Cooling for Skin Tightening n=3 Participants Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.	Laser Without Cooling for Skin Tightening n=2 Participants Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction.	1 units on a scale Standard Deviation 0	2 units on a scale Standard Deviation 0

Adverse Events

Laser With Cooling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laser Without Cooling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristen M. Kelly, M.D.

University of California, Irvine

Phone: 949-824-7103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place