Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars

NCT01813786 | Completed

• 1 other identifier: CYN12-PICO-CAPHST-07
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.

Conditions

Scars

Outcome Measures

Primary Outcomes (1)

• Subject Biopsy Sampling

  Histological examination of tissue samples will be compared between baseline and 3 months post treatment.

  3 months post last treatment

Secondary Outcomes (3)

• Photographic evaluation as a measure of improvement.

  up to 3 months post last treatment

• Subject Biopsy Sampling

  2 weeks post treatment

• Subject Biopsy Sampling

  1 month post treatment

Other Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability

  up to 3 months post last treatment

Study Arms (3)

755nm Alexandrite Laser with Handpiece 2

EXPERIMENTAL

Focusing energy on skin

Device: 755nm Alexandrite Laser with handpiece 2

755nm Alexandrite Laser with handpiece 3

EXPERIMENTAL

Focusing energy on skin

Device: 755nm Alexandrite Laser with handpiece 3

755nm Alexandrite laser with handpiece 1

EXPERIMENTAL

Focusing energy on skin

Device: 755nm Alexandrite Laser with handpiece 1

Interventions

755nm Alexandrite Laser with handpiece 2 DEVICE

Focusing energy on skin

755nm Alexandrite Laser with Handpiece 2

755nm Alexandrite Laser with handpiece 1 DEVICE

focusing energy at skin surface

755nm Alexandrite laser with handpiece 1

755nm Alexandrite Laser with handpiece 3 DEVICE

Focusing energy on skin

755nm Alexandrite Laser with handpiece 3

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 scars not including atrophic scars and wishes to undergo laser treatments.
• Is willing to consent to participate in the study.
• 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.
• Has Fitzpatrick skin types I to IV.

You may not qualify if:

• 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.
• The subject is hypersensitive to light exposure OR takes photo sensitized medication.
• The subject has active or localized systemic infections.
• 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}).
• The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• 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.
• The subject has used Accutane within 6 months prior to enrollment.
• The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
• The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
• The subject has a history of keloids.
• The subject has evidence of compromised wound healing.
• The subject has a history of squamous cell carcinoma or melanoma.
• The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
• The subjects has an allergy to lidocaine and epinephrine.

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

Cicatrix

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Patricia Krantz

  Cynosure, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 19, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

US (1)