Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars

• Sponsor: Cynosure, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01811030
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.

Condition or Disease	Intervention/Treatment	Phase
Scars	Device: 755nm Alexandrite Laser	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 755nm Alexandrite Laser 755nm Alexandrite Laser	Device: 755nm Alexandrite Laser; 755nm Alexandrite Laser

Outcome Measures

Primary Outcome Measures

1. Photographic Evaluation of Scar Clearance [1 Month Post Last Treatment]

   The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is >75% improvement.

2. Photographic Evaluation of Scar Clearance [3 Months Post Last Treatment]

   The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is >75% improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old.

2. Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them.

3. Is willing to consent to participate in the study.

4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits

Exclusion Criteria:

1. Is hypersensitive to light exposure.

2. Has active localized or systemic infection.

3. Is taking medication(s) for which sunlight is a contraindication.

4. Has a history of squamous cell carcinoma or melanoma.

5. Has a history of keloid scarring.

6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.

7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.

8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.

9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.

10. Has any other reason determined by the physician to be ineligible to participate in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laser & Skin Surgery Center of New York	New York	New York	United States	10016

Sponsors and Collaborators

• Cynosure, Inc.

Investigators

• Study Director: Patricia Krantz, Cynosure, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cynosure, Inc.
• ClinicalTrials.gov Identifier: NCT01811030
• Other Study ID Numbers: CYN12-PICO_SCARS_RG06
• First Posted: Mar 14, 2013
• Last Update Posted: Jan 14, 2021
• Last Verified: Dec 1, 2020

Study Results

Participant Flow

Arm/Group Title	755nm Alexandrite Laser
Arm/Group Description	755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser
Period Title: Overall Study
STARTED	33
COMPLETED	20
NOT COMPLETED	13

Baseline Characteristics

Arm/Group Title	755nm Alexandrite Laser
Arm/Group Description	755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser
Overall Participants	33
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	32 97%
>=65 years	1 3%
Sex: Female, Male (Count of Participants)
Female	25 75.8%
Male	8 24.2%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	21 63.6%
Hispanic	2 6.1%
Asian	4 12.1%
Black	6 18.2%
Fitzpatrick Skin Type (Count of Participants)
Fitzpatrick Skin Type I	2 6.1%
Fitzpatrick Skin Type II	12 36.4%
Fitzpatrick Skin Type III	9 27.3%
Fitzpatrick Skin Type IV	4 12.1%
Fitzpatrick Skin Type V	4 12.1%
Fitzpatrick Skin Type VI	2 6.1%

Outcome Measures

1. Primary Outcome

Title	Photographic Evaluation of Scar Clearance
Description	The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is >75% improvement.
Time Frame	1 Month Post Last Treatment

Outcome Measure Data

Analysis Population Description

7 subjects were lost to follow up. 3 subjects withdrew. 1 subject cancelled multiple appointments and could not come in.

Arm/Group Title	755nm Alexandrite Laser
Arm/Group Description	755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser
Measure Participants	22
Mean (Standard Deviation) [score on a scale]	1.82 (.73)

2. Primary Outcome

Title	Photographic Evaluation of Scar Clearance
Description	The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is >75% improvement.
Time Frame	3 Months Post Last Treatment

Outcome Measure Data

Analysis Population Description

9 subjects were lost to follow up. 3 subjects withdrew. 1 subject was not done due to patient's non-compliance. 2 subjects did not record overall clearance for this follow up.

Arm/Group Title	755nm Alexandrite Laser
Arm/Group Description	755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser
Measure Participants	18
Mean (Standard Deviation) [score on a scale]	2.28 (.75)

Adverse Events

Time Frame	Adverse Events occurring will be captured and followed throughout patients' participation in the study, approximately 17 months.
Arm/Group Title	755nm Alexandrite Laser
Arm/Group Description	755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser
All Cause Mortality
	755nm Alexandrite Laser
	Affected / at Risk (%)	# Events
Total	0/33 (0%)
Serious Adverse Events
	755nm Alexandrite Laser
	Affected / at Risk (%)	# Events
Total	0/33 (0%)
Other (Not Including Serious) Adverse Events
	755nm Alexandrite Laser
	Affected / at Risk (%)	# Events
Total	17/33 (51.5%)
Nervous system disorders
Pain	1/33 (3%)
Skin and subcutaneous tissue disorders
Redness	14/33 (42.4%)
Swelling	2/33 (6.1%)
Crusting	1/33 (3%)
Blistering	1/33 (3%)
Hypopigmentation	1/33 (3%)
Hyperpigmentation	2/33 (6.1%)
Pruritus	1/33 (3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.