755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars

• Sponsor: Cynosure, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01745627
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arm: 1
• Duration (Months): 26
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars

Condition or Disease	Intervention/Treatment	Phase
Benign Pigmented and Vascular Lesions and Scars	Device: 755nm Alex laser	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laser Treatment	Device: 755nm Alex laser

Outcome Measures

Primary Outcome Measures

1. Clearance Based on Photographic Scale [1 months post last treatment]

   This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.

2. Clearance Based on Photographic Scale [3 months post last treatment]

   This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy male or female subjects between 18 and 85 years of age.

2. Subjects with Fitzpatrick skin types I to VI.

3. Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars

4. Subject who are willing to consent to participate in the study.

4.2 Exclusion Criteria

1. Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule

2. Hypersensitive to light exposure.

3. Active localized or systemic infections.

4. Taking medication for which sunlight is a contraindication.

5. History of squamous cell carcinoma or melanoma.

6. History of keloid scarring.

7. Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.

8. Prior treatment with laser or other devices in treatment area within 3 months

9. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.

10. Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period.

11. Subjects that the physician determines ineligible based on standard of care treatment.

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: NCT01745627
• Other Study ID Numbers: CYN11-PICO_RG2_PL
• First Posted: Dec 10, 2012
• Last Update Posted: Dec 23, 2020
• Last Verified: Dec 1, 2020

Study Results

Participant Flow

Pre-assignment Detail	1 subject ID was never assigned, so the # of subjects who started the subject was actually 1 less than what the protocol said.

Arm/Group Title	Laser Treatment
Arm/Group Description	755nm Alex laser
Period Title: Overall Study
STARTED	42
COMPLETED	20
NOT COMPLETED	22

Baseline Characteristics

Arm/Group Title	Laser Treatment
Arm/Group Description	755nm Alex laser
Overall Participants	42
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	41 97.6%
>=65 years	1 2.4%
Sex: Female, Male (Count of Participants)
Female	36 85.7%
Male	6 14.3%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	24 57.1%
Asian	6 14.3%
Hispanic	9 21.4%
African American	2 4.8%
Hispanic/Other	1 2.4%
Fitzpatrick Skin Score (Count of Participants)
Fitzpatrick Skin Type I	4 9.5%
Fitzpatrick Skin Type II	14 33.3%
Fitzpatrick Skin Type III	14 33.3%
Fitzpatrick Skin Type IV	6 14.3%
Fitzpatrick Skin Type V	3 7.1%
Fitzpatrick Skin Type VI	1 2.4%

Outcome Measures

1. Primary Outcome

Title	Clearance Based on Photographic Scale
Description	This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.
Time Frame	1 months post last treatment

Outcome Measure Data

Analysis Population Description

19 subjects were lost to follow up after their treatment. 2 subjects did not have clearance data but had photographs for each of the follow up visits. 4 subjects did not attend the 1 month follow up, but attended a 3 month follow up, so their data was included. 2 subjects were not included in the trial.

Arm/Group Title	Laser Treatment
Arm/Group Description	755nm Alex laser
Measure Participants	15
>75%	2 4.8%
51-74%	2 4.8%
26-50%	4 9.5%
0-25%	7 16.7%

2. Primary Outcome

Title	Clearance Based on Photographic Scale
Description	This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.
Time Frame	3 months post last treatment

Outcome Measure Data

Analysis Population Description

19 subjects were lost to follow up, 2 subjects did not have clearance data but had photographs for each of the follow up visits. 6 subjects did not have data for this follow up visit but had data for the 1 month follow up visit, so their data were included. 2 subjects were not included in the trial.

Arm/Group Title	Laser Treatment
Arm/Group Description	755nm Alex laser
Measure Participants	13
>75%	2 4.8%
51-74%	2 4.8%
26-50%	4 9.5%
0-25%	5 11.9%

Adverse Events

Time Frame	Adverse Events occurring were captured and followed for each patient's participation in the study, approximately 26 months.
Arm/Group Title	Laser Treatment
Arm/Group Description	755nm Alex laser
All Cause Mortality
	Laser Treatment
	Affected / at Risk (%)	# Events
Total	0/42 (0%)
Serious Adverse Events
	Laser Treatment
	Affected / at Risk (%)	# Events
Total	0/42 (0%)
Other (Not Including Serious) Adverse Events
	Laser Treatment
	Affected / at Risk (%)	# Events
Total	17/42 (40.5%)
Infections and infestations
Infection	1/42 (2.4%)
Skin and subcutaneous tissue disorders
Redness	5/42 (11.9%)
Swelling	1/42 (2.4%)
Crusting	6/42 (14.3%)
Blistering	6/42 (14.3%)
Hypopigmentation	1/42 (2.4%)
Hyperpigmentation	1/42 (2.4%)
Puritis	1/42 (2.4%)

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.