New Surgical Scars, Scars
Conditions
Brief summary
The purpose of this study is to measure the effectiveness of the RevLite Laser in the treatment of both fresh surgical scars and mature/older scars.
Interventions
DEVICERevLite (Laser Treatment)
Sponsors
Cynosure, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Fitzpatrick Skin Type I-VI and either a fresh surgical scar (with sutures still present \[or dissolving sutures within 7 days of surgery for facial scars or within 14 days of surgery for scars on the trunk or extremities) of at least 2cm in length or an erythematous and/or hypertrophic scar of at least 2cm in length and of greater than or equal to 18 months in duration * Scar is easily divisible into two equal segments for the purpose of the study, or is bilateral in nature (e.g., inframammary)
Exclusion criteria
* Pregnant, lactating, or is planning to become pregnant * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical systemic therapy * coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy) * any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study * currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days * unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function * unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits * Isotretinoin therapy within 6 months * need to be exposed to artificial tanning devices or excessive sunlight during the trial * prior treatment with parenteral gold therapy * does not agree to refrain from other laser treatment, (micro)dermabrasion or topical scar treatment creams for the duration of the study * Diabetes Type 1 or 2 * Lupus, scleroderma or similar immune system disorder * underlying silicone or other non-absorbable filler in the area of the scar * phenol chemical peel or dermabrasion to the area of the scar within 3 months * Fitzpatrick Skin Type IV, V or VI with a known sensitivity to hydroquinone or is unwilling or unable to comply with physician/manufacturer instructions for the use of this ingredient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis | 1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars) | The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fresh Surgical Scars Treatment of scars
Device: Revlite | 0 |
| Mature Scars Treatment of scars
Device: Revlite | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Could not measure efficacy accurately | 0 | 7 |
Baseline characteristics
| Characteristic | Total | Mature Scars |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants |
| Age, Continuous | 48.4 years STANDARD_DEVIATION 10.2 | 48.4 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 7 participants | 7 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 7 |
| other Total, other adverse events | 0 / 0 | 0 / 7 |
| serious Total, serious adverse events | 0 / 0 | 0 / 7 |
Outcome results
Primary
Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis
The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted.
Time frame: 1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)
Population: Could not measure accurately with measurement tools.