Clinical Investigation of Safety and Efficacy of a Philips Intense Pulsed Light Device for Hair Reduction (Sunstone 2019)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hair Removal
- Sponsor
- Philips Healthcare
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Evaluation of safety of the Sunstone IPL device on removal of unwanted hair on face, axillae, bikini area and legs over the course of the treatment (12 treatments) and follow up (12 months).
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a prospective, multi-center, single-arm, single blinded study to evaluate the safety and efficacy of the Sunstone IPL (Intense Pulsed Light) device to remove hair.
Detailed Description
Prospective, multi-center, single-arm, single blinded (Philips hair counter) study in healthy women of skin types I up to and including V. Safety and efficacy of hair removal with the Investigational Philips IPL-device will be investigated. In-clinic, each study subject will undergo twelve IPL-treatments at four areas bilaterally (face, axilla, bikini line, and legs) with an investigational IPL device applied by a device operator. Hair re-growth in four body areas, face, axillae, bikini line and leg will be evaluated separately. After the 4 bi-weekly treatments, one follow-up visit will be organized. After the completion of full treatment cycle (12 treatments), subjects will be followed for 1 and 3 months (short-term follow-up) and for 6, 9 and 12 months (long-term follow up).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be willing to provide informed consent
- •Have a minimum of 24 hairs in each of the 2x4cm2 treatment area in axilla, bikini line, and leg, by visual inspection
- •Have a minimum of 10 hairs in the 1x2cm2 treatment area in face (upper lip), by visual inspection
- •Have a Fitzpatrick Skin Type I to V, with a melanin index less or equal to 553, as measured by Mexameter MX 18 in the designated treatment areas on face, axilla, bikini, and legs
- •Have natural body hair color that is dark blonde to black in the designated treatment areas
- •Are female subjects 18-65 years of age
- •Be either post-menopausal or surgically sterilized, or using a medically acceptable form of birth control (e.g., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence, etc.).
- •Be willing to participate in all scheduled study visits
- •Be willing to refrain from deliberate exposure to strong sun, products or procedures that would cause the skin to become darker in the designated treatment areas during the treatment phase
- •Be willing to refrain from the use of hair growth inhibitors/accelerators during the course of the study
Exclusion Criteria
- •Have fewer than 8 qualifying treatment areas: 2 in face (upper lip), 2 in axilla, 2 on bikini line, 2 on leg)
- •Have a malignant or pre-malignant pigmented lesion in the area to be treated
- •Have scarring or infection of the area to be treated
- •Have a known history of photosensitivity or use of medication known to induce photosensitivity
- •Are currently pregnant or lactating or planning to become pregnant in the period of the study, per subject report
- •Are currently on a daily dose of aspirin or NSAIDS (e.g. acetaminophen, ibuprofen, etc.) or have taken aspirin and/or NSAID within 5 days prior to treatment that would reduce or increase the sensation of pain
- •Are not willing to abstain from the use of products or light exposure that would induce tanning in the treatment areas during the IPL treatment period (first 10 months)
- •Have a history of immunosuppressive disease (including HIV infection or AIDS)
- •Are on anticoagulative medication or have thromboembolic condition
- •Any form of isotretinoin (such as Accutane or Roaccutane etc.) in the last six months.
Outcomes
Primary Outcomes
Evaluation of safety of the Sunstone IPL device on removal of unwanted hair on face, axillae, bikini area and legs over the course of the treatment (12 treatments) and follow up (12 months).
Time Frame: approximately 18 months
The analysis of the Primary safety endpoint will be based on the safety population which include all the enrolled subjects with at least one treatment. The primary safety endpoints include the treatment-emerged, anticipated adverse events (e.g. pain/discomfort, anticipated skin reactions.), non-anticipated adverse events, serious adverse events and reasons for discontinuation. Pain/discomfort will be evaluated per treatment per body area using the 5-point pain score grade. The percentage of the top-two scores will be calculated. Skin reactions will be assessed per treatment and body area, and will be described for type, onset, duration and severity. Incidence of adverse events will be summarized by frequency, severity and by relationship to device. Safety data will be summarized with descriptive statistics by body area, time points and clinical sites and combined.
Evaluation of the efficacy of the Sunstone IPL device on short-term hair reduction on face, axillae, bikini area and legs, 1 month after the last treatment (12 treatments).
Time Frame: approximately 11 months
The primary efficacy endpoint is the proportion of subjects with successful hair reduction at 1 month post-final treatment per body area. Successful hair reduction is defined as an average reduction in hair count at the given time point, that is greater than or equal to 30% relative to baseline hair count. Post-final treatment is defined as time point after the last of 12 treatments.
Evaluation of the efficacy of the Sunstone IPL device on short-term hair reduction on face, axillae, bikini area and legs, 3 months after the last treatment (12 treatments).
Time Frame: approximately 14 months
The primary efficacy endpoint is the proportion of subjects with successful hair reduction at 3 months post-final treatment per body area. Successful hair reduction is defined as an average reduction in hair count at the given time point, that is greater than or equal to 30% relative to baseline hair count. Post-final treatment is defined as time point after the last of 12 treatments.
Secondary Outcomes
- 4. Evaluation of the efficacy of the Sunstone IPL device on removal of unwanted hair on face, axillae, bikini area, and legs after the initial, intensive treatment phase at 8 weeks after baseline (2 weeks after the 4th treatment).(Approximately 2 months)
- 7. Assessment of the subjective satisfaction with the treatment results of the Sunstone IPL device s for removal of unwanted hair on face, axillae, bikini area, and legs.(Approximately 22 months)
- 5. Evaluation of the efficacy of the Sunstone IPL device on removal of unwanted hair on face, axillae, bikini area, and legs after the initial, intensive treatment phase at 10 weeks after baseline (4 weeks after the 4th treatment).(Approximately 4.5 months)
- 6. Evaluation of the stable long-term hair reduction efficacy in face, axillae, bikini area and legs, 6, 9 and 12 months after completion of the 12 treatments with the Sunstone IPL device.(Approximately 22 months)
- Evaluate time course of hair reduction during first four treatments(Approximately 2 months)
- 8. Assessment of the acceptance of the Philips investigational IPL devices for removal of unwanted hair in each body area.(Approximately 22 months)