Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions
Study Details
Study Description
Brief Summary
This study is intended to evaluate the efficacy and safety of a new diode fractional laser for skin resurfacing and treatment of pigmented lesions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
This study is a prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for skin resurfacing.
Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will receive up to 4 treatments to the face, and other off-face locations may be treated. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Group Single Group - single arm study |
Device: Nonablative Fractional Diode Laser
The FRAX 1940 is a fractional 1940 nm solid-state diode laser that delivers linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin.
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Outcome Measures
Primary Outcome Measures
- Formation of MENDS [4 Day Follow-up]
The number of days to formation of micro epidermal necrotic debris (MENDs).
- Formation of MENDS [14 Day Follow-up]
The number of days to healing of micro epidermal necrotic debris (MENDs).
Secondary Outcome Measures
- Number of participants with adverse events [From Day 0]
Number, severity and duration of adverse events following laser treatment.
- Change in Global Assessment Improvement Scale (GAIS). [Baseline vs. 1 Month Follow-up (post final treatment)]
Improvement in clearance of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles) on the Global Assessment Improvement Scale (GAIS).
- Change in Global Assessment Improvement Scale (GAIS). [Baseline vs. 3 Month Follow-up (post final treatment)]
Improvement in clearance of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles) on the Global Assessment Improvement Scale (GAIS).
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 V
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Willingness to have test spots and up to three (3) skin resurfacing treatments on the face
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Presence of pigmented lesions to be treated off the face must be 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(s)
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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
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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 skin resurfacing treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past six (6) months
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Prior injectable dermal fillers in the intended treatment areas within the past twelve (12) months
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Prior injectable toxins (Botox) in the treated areas 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 | Candela Institute for Excellence | Marlborough | Massachusetts | United States | 01752 |
Sponsors and Collaborators
- Candela Corporation
Investigators
- Principal Investigator: Konika P Schallen, M.D., Candela Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FRX19004