Unwanted Fine Facial Hair
Conditions
Keywords
Laser Hair Removal
Brief summary
This clinical study is intended to evaluate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended use of hair removal while using short pulse durations to improve the efficacy of achieving permanent reduction of fine facial hairs.
Detailed description
Prospective, non-randomized, open label trial to evaluate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended use of hair removal with variable pulse durations and spot sizes. Up to 30 subjects may be enrolled in this study at one (1) investigational site. Subjects having difficult to treat unwanted fine facial hairs having Fitzpatrick skin type (FST) I to VI are eligible for this study. In order to have a diverse sample of study subjects, the following criteria was established to ensure a wide array of skin types and race and ethnicities for data analysis. At least 15 subjects must have FST III to V. The remaining subjects can include other FST, but must still have fine facial hairs where permanent hair reduction is difficult to achieve with 3 ms pulses. Participants will receive four (4) laser hair removal treatment visits (with maximum interval of 10 weeks in between treatment visits) depending on the treatment area and three (3) follow up visits (1 month, 3 month, and 6 month after final treatment).
Interventions
DEVICEGentleMax Pro Plus 755nm and 1064nm laser system
The GentleMax Pro Plus is a 755nm and 1064nm laser system. The GentleMax Pro PlusTM is indicated for stable long-term or permanent hair reduction using varying spot sizes and fluences.
Sponsors
Candela Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 of desired characteristics and treatment location to be evaluated in this study 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 suntan 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in hair removal/ hair clearance | 12 Months | Improvement in hair removal/ hair clearance quantified by hair counts taken within a portion of the treatment area |
| Incidence, severity, and relatedness of adverse events | 12 Months | Analysis of the incidence, severity, and relatedness of adverse events to study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laser Hair Removal improvement | 12 Months | Overall level of improvement in laser hair removal as measured by Investigator using a 5-point Global Aesthetic Improvement Scale (IGAIS) (1= Very Much Improved, 5= Worse) |
| Subject satisfaction with treatment results | 12 Months | Overall subject satisfaction with study treatments as measured using a 5- point Subject Satisfaction Scale (1= Not Satisfied, 5= Very Satisfied) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject Pain Assessment | 6 months | Measurement of Subject Pain Assessment post-treatment for all subjects, using an 11-point Numerical Rating Scale (0=no pain, 10=extreme pain) |
Countries
United States
Outcome results
None listed