Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions
Study Details
Study Description
Brief Summary
This study is being conducted to evaluate the safety and efficacy of a fractional diode laser for treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for treatment of pigmented lesions.
Up to 60 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to three (3) treatments in the following treatment areas: face, hands, arms, back, chest, or legs. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final study treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Group Single Arm: All subjects will undergo treatment of pigmented lesions with a 1940 nm diode laser |
Device: FRAX 1940 nm laser
A fractional 1940 nm solid-state diode laser will deliver linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin, in order to treat pigmented skin lesions.
|
Outcome Measures
Primary Outcome Measures
- Change in pigmented lesions clearance [Baseline vs. 1 Month Follow-Up (post final treatment)]
Improvement in clearance of pigmented lesions via blinded review of Baseline photos vs. 1 Month Follow-Up (post final treatment) using a 5 Point Pigment Improvement Score ( 0 = 0% clearance/no improvement, 4 = 75-100% clearance/excellent response: most or all lesions much lighter or gone)
- Occurrence and severity of adverse events [Baseline - 3 Month Follow-Up (post final treatment)]
The number and level of severity of adverse events after laser treatment
Secondary Outcome Measures
- Skin textural improvement [1 Month Follow-Up and 3 Month Follow-Up (post final treatment)]
Improvement in skin texture via assessment at 1 Month and 3 Month Follow-Up (post final treatment) using a 5-point Global Aesthetic Improvement Scale (1 = Very Much Improved, 5 = Worse)
- Subject assessment of improvement in pigmented lesions clearance [1 Month Follow-Up and 3 Month Follow-Up (post final treatment)]
Improvement in clearance of pigmented lesions scored by subject using a 5-point Global Aesthetic Improvement Scale (1 = Very Much Improved, 5 = Worse)
- Subject satisfaction of treatment results [1 Month Follow-Up and 3 Month Follow-Up (post final treatment)]
Using a 5-point Subject Satisfaction scale, subjects will score satisfaction of treatment results (1 = Not Satisfied, 5 = Very Satisfied)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or Female
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Age 21 to 70
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Fitzpatrick Skin Type I to VI
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Willingness to have test spots and up to three (3) treatments for pigmented lesions on or off the face which are rated at baseline as moderate or higher per Investigator or study staff
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Provide signed informed consent to participate in the study
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Adhere to study treatment and follow-up schedules
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Willing to have hair removed from the intended treatment area prior to treatment and/or photography
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Avoid sun exposure to all treated areas and use of sunscreen with sun protection factor (SPF) 30 or greater throughout the duration of the study
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Adhere to post-treatment care instructions
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Allow photography of treated areas and to release their use for scientific and/or promotional purposes
Exclusion Criteria:
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Pregnant, planning to become pregnant, or breast feeding during the study
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Allergy to lidocaine or similar medications
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Excessively tanned skin in the intended treatment area
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Open wound or infection in the intended treatment area
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Tattoo(s) or permanent make-up in the intended treatment area
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Skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy
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Presence or history of melasma
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Presence or history of skin cancer within the treatment area
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History of keloid or hypertrophic scar formation
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History of herpes simplex virus (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
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Diagnosed coagulation disorder
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Immunosuppression disorder
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Presence of any medical condition that in the opinion of the Investigator could impair healing or outcome as a result of treatment
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Use of systemic retinoid therapy (e.g. Accutane) during the past six (6) months
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Use of topical retinoid therapy in the intended treatment area during the past two (2) weeks
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Use of oral corticosteroid therapy during the past four (4) weeks
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Prior treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past three (3) months
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Prior injectable dermal fillers (e.g. collagen, hyaluronic acid) in the intended treatment area within the past 12 months
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Prior injectable toxins (e.g. Botox) in the intended treatment area within the past three (3) months
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Subjects who in the opinion of the Investigator are unwilling or unable to adhere to the study requirements, or who are otherwise not a good candidate for the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Miami Dermatology and Laser Institute | Miami | Florida | United States | 33173 |
Sponsors and Collaborators
- Candela Corporation
- Miami Dermatology and Laser Institute
Investigators
- Principal Investigator: Jill S Waibel, M.D, Miami Dermatology and Laser Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FRX19005