Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus

Acne Clinical Trial

Official title:

Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro/ GentleMax Pro Plus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04993066
• Other study ID #: GMP19002, phase II
• Status: Completed
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: April 27, 2023

Study information

• Verified date: November 2023
• Source: Candela Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 27, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Onychomycosis
• Pigmented Lesions
• Pseudofolliculitis Barbae
• Vascular Lesion
• Wrinkle

Intervention

Device:
• GentleMax Pro Plus
The GentleMax Pro Plus laser system to be used in this study received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) under K201111 on May 26, 2020

Locations

Country	Name	City	State
United States	Candela Institute of Excellence	Marlborough	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Candela Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Time	Evaluate the speed (time of treatment completion) with larger spot sizes for hair removal	8 Months
Primary	Hair Count Assessments	Improvement in hair clearance quantified by hair counts taken within a portion of the treatment area and percent reduction by assessments of digital photos taken at Baseline compared to follow-ups.	14 Months
Primary	Global Aesthetic Improvement Score	Improvement in the appearance of wrinkles, benign pigmented lesions, and/or vascular lesions from baseline to follow-up(s) via the Investigator Global Aesthetic Improvement Score (IGAIS) whereas 1 = very much improved and 5 = worse. A lower score post treatment(s) indicates a better outcome.	7 Months
Primary	Fitzpatrick Wrinkle and Elastosis Score	Improvement in the appearance of wrinkles from baseline to follow-up(s) via the Investigator Fitzpatrick Wrinkle and Elastosis Scale whereas 1 = fine wrinkles and mild elastosis and 9 = deep wrinkles and severe elastosis. A lower score post treatment(s) indicates a better outcome.	7 Months
Primary	Pigment Improvement Score	Improvement in BPLs from baseline to follow-ups via the Investigator Pigment Improvement Score (PIS) whereas 0 = no improvement and 4 = excellent response. A higher score post treatment(s) indicates a better outcome.	7 Months
Primary	Acne Counts	Measured by improvement of acne counts from baseline compared to follow-ups. A lower score post treatment(s) indicates a better outcome.	5 Months
Primary	Onychomycosis Score	Improvement in the appearance of nails from Baseline to follow-up(s) via the Scoring Clinical Index of Onychomycosis (SCIO Index) which ranges from 0 to 30 whereas 0 indicates lesser degree of onychomycosis and 30 indicates higher degree of onychomycosis. A lower score post treatment(s) indicates a better outcome.	9 Months
Primary	Onychomycosis Score	Improvement in the appearance of nails from Baseline to follow-up(s) via the Onychomycosis Improvement Scale whereas 1 = completely cleared and 5 = worse. A lower score post treatment(s) indicates a better outcome.	9 Months
Secondary	Subject Satisfaction Score	Overall subject satisfaction with study treatments per treatment indication as measured by Subject Satisfaction Scale whereas 1 = not satisfied and 5 = very satisfied. A higher score post treatment(s) indicates a better outcome.	24 Months
Secondary	Subject Global Aesthetic Improvement Score	Overall subject improvement with study treatments per treatment indication as measured by Subject Global Aesthetic Improvement Score (SGAIS) whereas 1 = very much improved and 5 = worse. A lower score post treatment(s) indicates a better outcome.	24 Months
Secondary	Subject Pain	Measurement of Subject Pain Assessment post-treatment for all subjects, using an 11-point pain Numerical Rating Scale where 0=no pain, 10=extreme pain	8 Months