Localized LipodystrophyIH062905NCT00585715

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

A study testing 1064 nm Nd:YAG laser in people with Localized Lipodystrophy, run by University of California, Irvine at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research study is to evaluate effectiveness of a non-ablative (does not remove skin) treatment for cellulite (dimpled fat) in conjunction with skin tightening using the Candela GentleYAG laser. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Localized Lipodystrophy
What is being tested?: 1064 nm Nd:YAG laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 2 sitesUnited States
Study dates: Oct 2006to Jan 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Beckman Laser Institute
Irvine, California, 92697
UC Irvine Dermatology Clinical Research Center
Irvine, California, 92697

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Localized Lipodystrophy
Being tested: 1064 nm Nd:YAG laser
Keywords: Cellulite, Nd:YAG Laser
Medical subject headings: Cellulite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1064 nm Nd:YAG laserDevice
Also called Candela Gentle YAG Laser
3 treatments at 3-5 week intervals Spot size: 10 - 18 mm diameter Fluence: 50 J/cm2 Laser pulse duration: 50 ms Rep. rate: Up to 2 Hz DCD cooling 0-50 ms

Study groups in NCT00585715
Study group	Role	What they receive
Candela DCD with cooling	Experimental	Laser treatment with Candela DCD cooling which produces a cryogenic fluid that cools the epidermis prior to each laser pulse. Treatment will be conducted on either the left or the right thigh, which will also be randomly determined. The contra-lateral side will not be treated and will serve as a control. The laser system to be used in is Candela GentleYAG, a 1064nm Nd:YAG laser. This arm will receive a coolant during the laser procedure. Receives: Device: 1064 nm Nd:YAG laser
Candela DCD without Cooling	Active comparator	Laser treatment without cooling before each laser pulse. Treatment will be conducted on either the left or the right thigh, which will also be randomly determined. The contra-lateral side will not be treated and will serve as a control. The laser system to be used in is Candela GentleYAG, a 1064nm Nd:YAG laser. This arm will not receive a coolant during the laser procedure. Receives: Device: 1064 nm Nd:YAG laser

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Mild to Moderate Reduction in Cellulite.
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.
Measured: 6 month follow up
Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction.
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.
Measured: 6 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Jan 2010

First posted3 Jan 2008 (estimated)
Study startOct 2006
Primary completionDec 2009
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Localized LipodystrophyStudies of the same condition, open and under way.
More trials run by University of California, IrvineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00585715
Sponsor's protocol ID: 20065138
Other IDs: 062905, UCIaward#062905
Acronym: IH062905
Status last verified: Oct 2022
First submitted: 26 Dec 2007
Last updated: 21 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Truitt, A., Echague, A., Zachary, C. Kelly K.M. Evaluation of the Candela 1064 nm Nd:YAG Laser for Cellulite and Skin Tightening. Presented at the American Society for Laser Medicine and Surgery Annual Meeting, 2007, Dallas, TX.

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening
ClinicalTrials.gov ID: NCT00585715
Acronym / sponsor ID: IH062905 / 20065138
Conditions: Localized Lipodystrophy
Keywords: Cellulite, Nd:YAG Laser
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: University of California, IrvineUniversity, hospital or other
Collaborators: Candela Corporation
Study start: Oct 2006
Primary completion: Dec 2009 (actual)
Study completion: Jan 2010 (actual)
First posted: 3 Jan 2008 (estimated)
Results: Posted 16 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Candela DCD with cooling	Experimental	Device: 1064 nm Nd:YAG laserLaser treatment with Candela DCD cooling which produces a cryogenic fluid that cools the epidermis prior to each laser pulse. Treatment will be conducted on either the left or the right thigh, which will also be randomly determined. The contra-lateral side will not be treated and will serve as a control. The laser system to be used in is Candela GentleYAG, a 1064nm Nd:YAG laser. This arm will receive a coolant during the laser procedure.
Candela DCD without Cooling	Active comparator	Device: 1064 nm Nd:YAG laserLaser treatment without cooling before each laser pulse. Treatment will be conducted on either the left or the right thigh, which will also be randomly determined. The contra-lateral side will not be treated and will serve as a control. The laser system to be used in is Candela GentleYAG, a 1064nm Nd:YAG laser. This arm will not receive a coolant during the laser procedure.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1064 nm Nd:YAG laserAlso: Candela Gentle YAG Laser3 treatments at 3-5 week intervals Spot size: 10 - 18 mm diameter Fluence: 50 J/cm2 Laser pulse duration: 50 ms Rep. rate: Up to 2 Hz DCD cooling 0-50 ms	Device	Candela DCD with cooling, Candela DCD without Cooling

Primary outcome

Number of Participants With Mild to Moderate Reduction in Cellulite.
Time frame: 6 month follow up
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.
Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction.
Time frame: 6 month follow up
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.

Results and safety

Results posted to the registry on 16 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Laser With Cooling	11	8
Laser Without Cooling	11	11

Primary outcome: Number of Participants With Mild to Moderate Reduction in Cellulite.

Time frame: 6 month follow up. Number. Unit: participants

Measure	Laser With Cooling for Skin Tightening n = 7	Laser Without Cooling for Skin Tightening n = 9
Value	3	2

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

Primary outcome: Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction.

Time frame: 6 month follow up. Mean (Standard Deviation). Unit: units on a scale

Measure	Laser With Cooling for Skin Tightening n = 3	Laser Without Cooling for Skin Tightening n = 2
Value	1 (0)	2 (0)

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

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Laser With Cooling	0 of 8 (0%)	0 of 8 (0%)	Not reported
Laser Without Cooling	0 of 11 (0%)	0 of 11 (0%)	Not reported

Limitations and caveats (from the sponsor): Small sample size

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationTruitt, A., Echague, A., Zachary, C. Kelly K.M. Evaluation of the Candela 1064 nm Nd:YAG Laser for Cellulite and Skin Tightening. Presented at the American Society for Laser Medicine and Surgery Annual Meeting, 2007, Dallas, TX.
UC Irvine Department of Dermatology Clinical ResearchLink provided by the sponsor.
Beckman Laser InstituteLink provided by the sponsor.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kristen M Kelly, M.D. principal investigator

University of California, Irvine

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 1064 nm Nd:YAG laser in people with Localized Lipodystrophy, run by University of California, Irvine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Mild to Moderate Reduction in Cellulite. (time frame: 6 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00585715, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.