Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars

• Sponsor: Cynosure, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02103127
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this study is to assess treatment of facial acne scars using the 755nm Alexandrite Laser with lens arrays.

Condition or Disease	Intervention/Treatment	Phase
Acne Scars	Device: 755nm Alexandrite laser with lens array	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 755nm Alexandrite laser with lens array	Device: 755nm Alexandrite laser with lens array

Outcome Measures

Primary Outcome Measures

1. Severity Change in Acne Scarring [Baseline and 1 month post treatment]

   The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).

2. Severity Change in Acne Scarring [Baseline and 3 months post treatment]

   The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).

Secondary Outcome Measures

1. Investigator Satisfaction Questionnaire [3 months post treatment]

   Investigator will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.

2. Subject Satisfaction Questionnaire [3 months post treatment]

   Subject will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Is a healthy male or female between 18 and 65 years old

2. Has unwanted acne scars, excluding ice pick scars (Deep atrophic scars that resemble poked holes), and wishes to undergo laser treatments.

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

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

Exclusion Criteria:

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

2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.

3. The subject has active or localized systemic infections.

4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).

5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.

6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.

7. The subject has used Accutane within 6 months prior to enrollment.

8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.

9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).

10. The subject has a history of keloids.

11. The subject has evidence of compromised wound healing.

12. The subject has a history of squamous cell carcinoma or melanoma.

13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.

14. The subject has an allergy to lidocaine and epinephrine.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laser & Skin Surgery Center of Northern California	Sacramento	California	United States	95816

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: NCT02103127
• Other Study ID Numbers: CYN13-PCAP-AS-SK02
• First Posted: Apr 3, 2014
• Last Update Posted: Jan 15, 2021
• Last Verified: Dec 1, 2020

• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Arm/Group Title	755nm Alexandrite Laser With Lens Array
Arm/Group Description	755nm Alexandrite laser with lens array
Period Title: Overall Study
STARTED	20
COMPLETED	17
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	755nm Alexandrite Laser With Lens Array
Arm/Group Description	755nm Alexandrite laser with lens array
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	19 95%
Male	1 5%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	16 80%
Asian	0 0%
African American	0 0%
Hispanic	3 15%
Other	1 5%
Fitzpatrick Skin Type (Count of Participants)
Fitzpatrick Skin Score I	0 0%
Fitzpatrick Skin Score II	13 65%
Fitzpatrick Skin Score III	3 15%
Fitzpatrick Skin Score IV	4 20%
Fitzpatrick Skin Score V	0 0%
Fitzpatrick Skin Score VI	0 0%

Outcome Measures

1. Primary Outcome

Title	Severity Change in Acne Scarring
Description	The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).
Time Frame	Baseline and 1 month post treatment

Outcome Measure Data

Analysis Population Description

1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent. 3 subjects missed their visits.

Arm/Group Title	755nm Alexandrite Laser With Lens Array
Arm/Group Description	755nm Alexandrite laser with lens array
Measure Participants	14
Mean (Standard Deviation) [score on a scale]	-2 (2.71)

2. Secondary Outcome

Title	Investigator Satisfaction Questionnaire
Description	Investigator will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.
Time Frame	3 months post treatment

Outcome Measure Data

Analysis Population Description

1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent.

Arm/Group Title	755nm Alexandrite Laser With Lens Array
Arm/Group Description	755nm Alexandrite laser with lens array
Measure Participants	17
Extremely Satisfied	0 0%
Satisfied	10 50%
Dissatisfied	7 35%
Extremely Dissatisfied	0 0%

3. Secondary Outcome

Title	Subject Satisfaction Questionnaire
Description	Subject will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.
Time Frame	3 months post treatment

Outcome Measure Data

Analysis Population Description

1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent.

Arm/Group Title	755nm Alexandrite Laser With Lens Array
Arm/Group Description	755nm Alexandrite laser with lens array
Measure Participants	17
Extremely Satisfied	3 15%
Satisfied	11 55%
Dissatisfied	3 15%
Extremely Dissatisfied	0 0%

4. Primary Outcome

Title	Severity Change in Acne Scarring
Description	The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).
Time Frame	Baseline and 3 months post treatment

Outcome Measure Data

Analysis Population Description

1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent.

Arm/Group Title	755nm Alexandrite Laser With Lens Array
Arm/Group Description	755nm Alexandrite laser with lens array
Measure Participants	17
Mean (Standard Deviation) [score on a scale]	-1 (3.15)

Adverse Events

Time Frame	Adverse Events occurring will be captured and followed throughout each subject's participation in the study, approximately 10 months.
Arm/Group Title	755nm Alexandrite Laser With Lens Array
Arm/Group Description	755nm Alexandrite laser with lens array
All Cause Mortality
	755nm Alexandrite Laser With Lens Array
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	755nm Alexandrite Laser With Lens Array
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	755nm Alexandrite Laser With Lens Array
	Affected / at Risk (%)	# Events
Total	17/20 (85%)
Skin and subcutaneous tissue disorders
Redness	17/20 (85%)
Edema	11/20 (55%)

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.