755nm Alex Laser for Treatment of Stretch Marks

NCT01745211 | Completed Results

• 1 other identifier: CYN12-PICO-STRIAE_RG4
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Striae

Outcome Measures

Primary Outcomes (1)

• Photographic Evaluation of Striae Clearance

  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.

  Follow Up Between 1 and 3 Months Post Last Treatment

Study Arms (1)

755nm Alexandrite laser with array handpiece

EXPERIMENTAL

Device: 755nm Alexandrite laser with array handpiece

Device: 755nm Alexandrite Laser

Interventions

755nm Alexandrite Laser DEVICE

755nm Alexandrite laser with array handpiece

755nm Alexandrite laser with array handpiece

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a healthy male or female between 18 and 85 years old.
• Has unwanted striae and wishes to undergo laser treatments to remove or improve them.
• Is willing to consent to participate in the study.
• 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.

You may not qualify if:

• Is hypersensitive to light exposure.
• Has active localized or systemic infection.
• Is taking medication(s) for which sunlight is a contraindication.
• Has a history of squamous cell carcinoma or melanoma.
• Has a history of keloid scarring.
• 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.
• Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
• Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
• Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
• Has any other reason determined by the physician to be ineligible to participate in the study.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Striae Distensae

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

800-886-2966

Study Officials

• Patricia Krantz

  Cynosure, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 9, 2021
• Results First Posted: February 9, 2021

Record last verified: 2021-01

Locations

US (1)