An interventional study of Treatment with IPL device in Hair Removal, sponsored by Philips Healthcare. Completed at 2 sites in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-20.
Sponsored by Philips Healthcare · Not applicable, Interventional, and Treatment
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.
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).
Exclusion Criteria:
Participating in other clinical studies prior to, or concurrently with this study, that could be deemed to interfere with full and complete participation in this study - as determined by the site Investigator.
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This study will be conducted in women, aged 18 to 65 years, with skin types I up to and including V, and measured melanin values of ≤ 553 Melanin index in each qualifying treatment area in face (upper lip), axilla, bikini line, and leg. Each of the 2cm x 4cm treatment area bilateral located in axilla, bikini line and leg should count a minimum of 24 hairs. In face (upper lip) on upper lip, a minimum of 10 hairs should be available in each of the 1cm x 2cm selected treatment area bilateral located. The procedure to define the treatment area is described in the Training Manual \[5\]. Skin type must be determined based on an evaluation by a dermatologist or designee at site according to the Fitzpatrick Skin Type Scale.
Device: Treatment with IPL device
Exposure of body parts to the IPL device
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).
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.
Time frame: approximately 18 months
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).
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.
Time frame: approximately 11 months
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).
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.
Time frame: approximately 14 months
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).
Proportion of subjects with successful hair reduction (greater than or equal to 30% relative to baseline) at 8 weeks post-baseline (2 weeks after the 4th treatment) per body area.
Time frame: Approximately 2 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).
Proportion of subjects with successful hair reduction (greater than or equal to 30% relative to baseline) at 10 weeks post-baseline (4 weeks after the 4th treatment) per body area.
Time frame: 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.
Proportion of subjects with successful hair reduction (greater than or equal to 30% relative to baseline) at 6, 9 and 12 months post-final treatment (12 treatments) per body area.
Time frame: Approximately 22 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.
Percent of top-two category answers of 5-point Likert satisfaction scale in assessment of subjective satisfaction with the treatment results in all body areas.
Time frame: Approximately 22 months
8. Assessment of the acceptance of the Philips investigational IPL devices for removal of unwanted hair in each body area.
Percent of top-two category answers in assessment of acceptance of hair reduction, skin smoothness, and comfort after treatment with Philips investigational IPL devices in all body areas.
Time frame: Approximately 22 months
Evaluate time course of hair reduction during first four treatments
Evaluate the time course of hair reduction to baseline achieved by the Philips investigational IPL device for each body area during the first four treatments, i.e. during the Intensive Treatment phase.
Time frame: Approximately 2 months
Exploratory objective to assess subjective selection of setting compared to device setting
Exploratory objective: Assess the percentage of subjects who select a setting based on comfort, which is the same setting as indicated by the device.
Time frame: Approximately 18 months
Plan to share: No
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Philips Healthcare