Clinical trial NCT04202419: Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions
Official title: Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Treatment of Pigmented Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pigmented Skin Lesion
Lead sponsor: Candela Corporation
Sponsor class: INDUSTRY
Collaborators: name: Miami Dermatology and Laser Institute
First posted: 2019-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

1. Male or Female
2. Age 21 to 70
3. Fitzpatrick Skin Type I to VI
4. 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
5. Provide signed informed consent to participate in the study
6. Adhere to study treatment and follow-up schedules
7. Willing to have hair removed from the intended treatment area prior to treatment and/or photography
8. 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
9. Adhere to post-treatment care instructions
10. Allow photography of treated areas and to release their use for scientific and/or promotional purposes

Exclusion Criteria:

1. Pregnant, planning to become pregnant, or breast feeding during the study
2. Allergy to lidocaine or similar medications
3. Excessively tanned skin in the intended treatment area
4. Open wound or infection in the intended treatment area
5. Tattoo(s) or permanent make-up in the intended treatment area
6. Skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy
7. Presence or history of melasma
8. Presence or history of skin cancer within the treatment area
9. History of keloid or hypertrophic scar formation
10. History of herpes simplex virus (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
11. Diagnosed coagulation disorder
12. Immunosuppression disorder
13. Presence of any medical condition that in the opinion of the Investigator could impair healing or outcome as a result of treatment
14. Use of systemic retinoid therapy (e.g. Accutane) during the past six (6) months
15. Use of topical retinoid therapy in the intended treatment area during the past two (2) weeks
16. Use of oral corticosteroid therapy during the past four (4) weeks
17. Prior treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past three (3) months
18. Prior injectable dermal fillers (e.g. collagen, hyaluronic acid) in the intended treatment area within the past 12 months
19. Prior injectable toxins (e.g. Botox) in the intended treatment area within the past three (3) months
20. 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

Primary outcomes:
measure: Pigmented Lesion Improvement by Blinded Evaluation
timeFrame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Secondary outcomes:
measure: Pigmentation Improvement at the 3-month Follow-up, by Blinded Evaluation
timeFrame: 3-months post final treatment, where treatment series could last up to 10 weeks after baseline
measure: Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS)
timeFrame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
measure: Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS)
timeFrame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
measure: Subject Satisfaction With Treatment Results
timeFrame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Dermatology and Laser Institute
state: Florida
Study officials:
affiliation: Miami Dermatology and Laser Institute
name: Jill S Waibel, M.D
role: PRINCIPAL_INVESTIGATOR
References: