Scars
Conditions
Brief summary
Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.
Interventions
DEVICE755nm Alexandrite Laser with handpiece 2
Focusing energy on skin
DEVICE755nm Alexandrite Laser with handpiece 1
focusing energy at skin surface
DEVICE755nm Alexandrite Laser with handpiece 3
Focusing energy on skin
Sponsors
Cynosure, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Biopsy Sampling | 3 months post last treatment | Histological examination of tissue samples will be compared between baseline and 3 months post treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Photographic evaluation as a measure of improvement. | up to 3 months post last treatment | 2D photographs to be taken at each visit and assessed at the end of the study by 2-3 blinded assessors for improvement. |
| Subject Biopsy Sampling | 2 weeks post treatment | Histological examination of tissue samples will be compared between baseline and 2 weeks post treatment. |
Other
| Measure | Time frame |
|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | up to 3 months post last treatment |
Countries
United States
Outcome results
None listed