Clinical trial NCT04203745: Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions
Official title: Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Skin Resurfacing and Treatment of Pigmented Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Texture
Pigmented Lesions
Lead sponsor: Candela Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-18
Enrollment: 26
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 intended to evaluate the efficacy and safety of a new diode fractional laser for skin resurfacing and treatment of pigmented lesions.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or Female
2. Age 21 to 70
3. Fitzpatrick Skin Type I to V
4. Willingness to have test spots and up to three (3) skin resurfacing treatments on the face
5. Presence of pigmented lesions to be treated off the face must be rated at baseline as moderate or higher per Investigator or study staff
6. Provide signed informed consent to participate in the study
7. Adhere to study treatment and follow-up schedules
8. Willing to have hair removed from the intended treatment area prior to treatment and/or photography
9. 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
10. Adhere to post-treatment care instructions
11. 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(s)
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
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 skin resurfacing treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past six (6) months
18. Prior injectable dermal fillers in the intended treatment areas within the past twelve (12) months
19. Prior injectable toxins (Botox) in the treated areas 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 from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Marlborough
country: United States
facility: Candela Institute for Excellence
state: Massachusetts
Study officials:
affiliation: Candela Corporation
name: Konika P Schallen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: