NCT03921814

Sunstone IPL (Intense Pulsed Light) for Hair Reduction

Clinical Investigation of Safety and Efficacy of a Philips Intense Pulsed Light Device for Hair Reduction (Sunstone 2019)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Philips Healthcare · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Hair Removal

Interventions

Type	Name	Description
DEVICE	Treatment with IPL device	Exposure of body parts to the IPL device

Timeline

• Start date: 2019-04-11
• Primary completion: 2021-09-23
• Completion: 2022-05-20
• First posted: 2019-04-19
• Last updated: 2022-10-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study