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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: IPL-home use device

• Registration Number: NCT01763723
• Lead Sponsor: Bispebjerg Hospital

Brief 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-09
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Healthy, over 18 years, no childbearing potential, signed informed consent, no moles,tattoos, freckles or scars in the test-area, skin type II-IV

Exclusion Criteria

• disease in test-area, prior treatment to IPL, taking drugs interfering with the immune system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPL after UV-exposure	IPL-home use device	8 UV-exposures followed by 3 weekly IPL exposures

Primary Outcome Measures

Name	Time	Method
Changes in skin reaction development	Immediately after, 1 hr after, 16-24 hrs after, 1 week and 4 weeks after IPL exposure	Redness, edema, pigment changes, texture changes, blisters and crusting

Secondary Outcome Measures

Name	Time	Method
Pain	Immediately after IPL exposure (approx. 2 min)

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Bispebjerg, Denmark