Clinical trial NCT01813786: Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scars
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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


Eligibility criteria: Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old
2. Has unwanted scars not including atrophic scars 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.
5. Has Fitzpatrick skin types I to IV.

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 subjects has an allergy to lidocaine and epinephrine.

Primary outcomes:
measure: Subject Biopsy Sampling
timeFrame: 3 months post last treatment
Secondary outcomes:
measure: Photographic evaluation as a measure of improvement.
timeFrame: up to 3 months post last treatment
measure: Subject Biopsy Sampling
timeFrame: 2 weeks post treatment
measure: Subject Biopsy Sampling
timeFrame: 1 month post treatment
Other outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: up to 3 months post last treatment
Locations:
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References: