NCT01763723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

December 20, 2012

Last Update Submit

July 30, 2015

Conditions

Healthy

Keywords

Intense pulsed light,UV-exposure,skin type,safety,pigment,home-usesubjects

Outcome Measures

Primary Outcomes (1)

  • Changes in skin reaction development

    Redness, edema, pigment changes, texture changes, blisters and crusting

    Immediately after, 1 hr after, 16-24 hrs after, 1 week and 4 weeks after IPL exposure

Secondary Outcomes (1)

  • Pain

    Immediately after IPL exposure (approx. 2 min)

Other Outcomes (1)

  • mRNA expression of pigment markers

    16-24 hrs after the first IPL exposure

Study Arms (1)

IPL after UV-exposure

EXPERIMENTAL

8 UV-exposures followed by 3 weekly IPL exposures

Device: IPL-home use device

Interventions

IPL-home use deviceDEVICE

A light based home use device for hair removal

IPL after UV-exposure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Bispebjerg, 2400, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

December 20, 2012

First Posted

January 9, 2013

Study Start

April 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

DK(1)