Clinical trial NCT04993066: Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus
Official title: Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro/ GentleMax Pro Plus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pseudofolliculitis Barbae
Unwanted Hair
Pigmented Lesions
Vascular Lesion
Onychomycosis
Wrinkle
Acne
Lead sponsor: Candela Corporation
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Demonstrate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended uses: hair removal including pseudofolliculitis barbae (PFB), clearance of pigmented and/or vascular lesions, temporary increase of clear nail in patients with onychomycosis and improvement in appearance of wrinkles. Evaluate GentleMax Pro Plus™ laser system for the clearance of acne.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age or older
2. Willingness to provide signed, informed consent to participate in the study
3. Presence of unwanted hair, moderate or greater benign pigmented lesions, active acne, vascular lesions, nails affected with onychomycosis, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) \>/= 1
4. Willingness to adhere to study treatment and follow-up schedule
5. Willingness to adhere to post-treatment care instructions
6. Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
7. Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study

Exclusion Criteria:

1. Pregnant, planning pregnancy during the study, or breast feeding
2. Blonde, grey, or white hair in subjects seeking hair removal
3. Tattooed skin in the intended treatment area
4. Active sun tan in the intended treatment area
5. History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
6. History of melanoma
7. History of vitiligo in the intended treatment area
8. History of keloid or hypertrophic scar formation
9. History of Melasma in the intended treatment area or per Investigator's discretion
10. Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment
11. Open wound or infection in the intended treatment area
12. History of light induced seizure disorders
13. The subject is not suitable, in the opinion of the Investigator, for participation in the study due to inability to adhere to the study requirements, medical, or other reasons that could compromise the study integrity or subject safety
14. Dermatologic and/or cosmetic procedures including use of medications, or topicals in the intended treatment area(s) during a timepoint prior to the study that the investigator deems the subject unsuitable for the study

Primary outcomes:
measure: Treatment Time
timeFrame: 8 Months
measure: Hair Count Assessments
timeFrame: 14 Months
measure: Global Aesthetic Improvement Score
timeFrame: 7 Months
measure: Fitzpatrick Wrinkle and Elastosis Score
timeFrame: 7 Months
measure: Pigment Improvement Score
timeFrame: 7 Months
measure: Acne Counts
timeFrame: 5 Months
measure: Onychomycosis Score
timeFrame: 9 Months
measure: Onychomycosis Score
timeFrame: 9 Months
Secondary outcomes:
measure: Subject Satisfaction Score
timeFrame: 24 Months
measure: Subject Global Aesthetic Improvement Score
timeFrame: 24 Months
measure: Subject Pain
timeFrame: 8 Months
Other outcomes:
Locations:
city: Marlborough
country: United States
facility: Candela Institute of Excellence
state: Massachusetts
Study officials:
References: