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This clinical study is intended to evaluate the safety and efficacy of the GentleMax Pro Plusâ„¢ 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.
Prospective, non-randomized, open label trial to evaluate the safety and efficacy of the GentleMax Pro Plusâ„¢ 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unwanted Fine Facial Hair | Experimental | Up to three (3) treatments with GentleMax Pro/ GentleMax Pro Plus TM for Laser Hair Removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GentleMax Pro Plus 755nm and 1064nm laser system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in hair removal/ hair clearance | Improvement in hair removal/ hair clearance quantified by hair counts taken within a portion of the treatment area | 12 Months |
| Incidence, severity, and relatedness of adverse events | Analysis of the incidence, severity, and relatedness of adverse events to study treatment. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Laser Hair Removal improvement | 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) | 12 Months |
| Subject satisfaction with treatment results |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Pain Assessment | Measurement of Subject Pain Assessment post-treatment for all subjects, using an 11-point Numerical Rating Scale (0=no pain, 10=extreme pain) | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Candela Institute of Excellence | Marlborough | Massachusetts | 01752 | United States |
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Overall subject satisfaction with study treatments as measured using a 5- point Subject Satisfaction Scale (1= Not Satisfied, 5= Very Satisfied) |
| 12 Months |
| Subject satisfaction with treatment results | Overall subject satisfaction with study treatments as measured using a 5- point Subject Global Aesthetic Improvement Scale (SGAIS) (1= Very Much Improved, 5= Worse) | 12 Months |