NCT01763723

Pigment-Tan-Safety Study of a Light-based Home Device for Hair Removal in Adult Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This studies was designed to investigate the importance of skin type and UV-exposure on side effects after exposure to an Intense Pulsed Light Home-use device. 21 healthy subjects will receive 8 UV-exposures on one buttock and subsequently three weekly IPL-exposures.

Detailed description

Twenty-one healthy subjects will be exposed to UV-exposures 8 times over 3 weeks on a test-area (4 x 6cm) on one buttock to induce pigmentation. This will be followed by 3 weekly IPL (intense pulsed light) exposures. At 24 hours after the first IPL exposure, biopsies will be excised from the buttocks of the subjects (4 each).The skin will be evaluated after IPL exposure for: skin reactions, pain and mRNA expression of two pigment markers. Follow-up visits is planned at 1 and 4 weeks after the third and final IPL exposure.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	IPL-home use device	A light based home use device for hair removal

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-01-09
• Last updated: 2015-07-31

Locations

1 site across 1 country: Denmark