755nm Alex Laser for Treatment of Stretch Marks

• Sponsor: Cynosure, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01745211
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm Alexandrite laser.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 755nm Alexandrite laser with array handpiece Device: 755nm Alexandrite laser with array handpiece	Device: 755nm Alexandrite Laser; 755nm Alexandrite laser with array handpiece

Outcome Measures

Primary Outcome Measures

1. Photographic Evaluation of Striae Clearance [Follow Up Between 1 and 3 Months Post Last Treatment]

   The physician will judge the overall improvement by selecting from improvement ranges of 0-25%, 25-50%, 50-75%, or 75-100% clearance when compared to the baseline.

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 striae 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: NCT01745211
• Other Study ID Numbers: CYN12-PICO-STRIAE_RG4
• First Posted: Dec 10, 2012
• Last Update Posted: Feb 9, 2021
• Last Verified: Jan 1, 2021

Study Results

Participant Flow

Pre-assignment Detail	Each patient's striation area was treated with the array handpiece. No patients were treated with the standard handpiece.

Arm/Group Title	755nm Alexandrite Laser
Arm/Group Description	755nm Alexandrite laser with array handpiece
Period Title: Overall Study
STARTED	45
COMPLETED	27
NOT COMPLETED	18

Baseline Characteristics

Arm/Group Title	755nm Alexandrite Laser
Arm/Group Description	755nm Alexandrite laser (standard handpiece) 755nm Alexandrite Laser: 755nm Alexandrite laser with modified and standard handpiece
Overall Participants	45
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	45 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	40 88.9%
Male	5 11.1%
Race/Ethnicity, Customized (Count of Participants)
African American	6 13.3%
Asian	5 11.1%
Hispanic	9 20%
W. Indian	1 2.2%
Caucasian	24 53.3%
Fitzpatrick Skin Score (Count of Participants)
Fitzpatrick Skin Score I	4 8.9%
Fitzpatrick Skin Score II	9 20%
Fitzpatrick Skin Score III	17 37.8%
Fitzpatrick Skin Score IV	9 20%
Fitzpatrick Skin Score V	2 4.4%
Fitzpatrick Skin Score VI	4 8.9%

Outcome Measures

1. Primary Outcome

Title	Photographic Evaluation of Striae Clearance
Description	The physician will judge the overall improvement by selecting from improvement ranges of 0-25%, 25-50%, 50-75%, or 75-100% clearance when compared to the baseline.
Time Frame	Follow Up Between 1 and 3 Months Post Last Treatment

Outcome Measure Data

Analysis Population Description

5 subject withdrew and 13 were lost to follow up.

Arm/Group Title	755nm Alexandrite Laser With Array Handpiece
Arm/Group Description	755nm Alexandrite Laser: 755nm Alexandrite laser with array handpiece
Measure Participants	27
Measure areas with striation	64
0-25% Improvement from Baseline	36
25-50% Improvement from Baseline	17
50-75% Improvement from Baseline	11

Adverse Events

Time Frame	Adverse events, whether serious or non-serious, were followed throughout study completion, about 18 months.
Arm/Group Title	755nm Alexandrite Laser
Arm/Group Description	755nm Alexandrite laser 755nm Alexandrite Laser: 755nm Alexandrite laser with array handpiece
All Cause Mortality
	755nm Alexandrite Laser
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Serious Adverse Events
	755nm Alexandrite Laser
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Other (Not Including Serious) Adverse Events
	755nm Alexandrite Laser
	Affected / at Risk (%)	# Events
Total	26/45 (57.8%)
Skin and subcutaneous tissue disorders
Redness	23/45 (51.1%)
Crusting	1/45 (2.2%)
Blistering	1/45 (2.2%)
Burn	1/45 (2.2%)

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.