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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04993066
Recruitment Status : Active, not recruiting
First Posted : August 6, 2021
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
Candela Corporation

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.

Condition or disease Intervention/treatment Phase
Pseudofolliculitis Barbae Unwanted Hair Pigmented Lesions Vascular Lesion Onychomycosis Wrinkle Acne Device: GentleMax Pro Plus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro/ GentleMax Pro Plus
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Experimental: Treatment Arm
All study subjects are to receive treatment with GentleMax Pro Plus device. Subjects will be scheduled to receive as little as one (1) and up to eight (8) treatments with the GentleMax Pro Plus™ Laser System. Up to 2 follow-ups will occur.
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




Primary Outcome Measures :
  1. Treatment Time [ Time Frame: 8 Months ]
    Evaluate the speed (time of treatment completion) with larger spot sizes for hair removal

  2. Hair Count Assessments [ Time Frame: 14 Months ]
    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.

  3. Global Aesthetic Improvement Score [ Time Frame: 7 Months ]
    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.

  4. Fitzpatrick Wrinkle and Elastosis Score [ Time Frame: 7 Months ]
    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.

  5. Pigment Improvement Score [ Time Frame: 7 Months ]
    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.

  6. Acne Counts [ Time Frame: 5 Months ]
    Measured by improvement of acne counts from baseline compared to follow-ups. A lower score post treatment(s) indicates a better outcome.

  7. Onychomycosis Score [ Time Frame: 9 Months ]
    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.

  8. Onychomycosis Score [ Time Frame: 9 Months ]
    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.


Secondary Outcome Measures :
  1. Subject Satisfaction Score [ Time Frame: 24 Months ]
    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.

  2. Subject Global Aesthetic Improvement Score [ Time Frame: 24 Months ]
    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.

  3. Subject Pain [ Time Frame: 8 Months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04993066


Locations
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United States, Massachusetts
Candela Institute of Excellence
Marlborough, Massachusetts, United States, 01752
Sponsors and Collaborators
Candela Corporation
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Responsible Party: Candela Corporation
ClinicalTrials.gov Identifier: NCT04993066    
Other Study ID Numbers: GMP19002, phase II
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: N/A, no plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Nail Diseases
Skin Diseases