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CompletedNCT01763723Updated Jul 31, 2015

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

An interventional study of IPL-home use device in Healthy, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Intense pulsed light,
  • UV-exposure,
  • skin type,
  • safety,
  • pigment,
  • home-use
  • subjects
03

In context

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • disease in test-area, prior treatment to IPL, taking drugs interfering with the immune system
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    IPL after UV-exposure

    8 UV-exposures followed by 3 weekly IPL exposures

    Device: IPL-home use device

Interventions

  • DeviceIPL-home use device

    A light based home use device for hair removal

06

What researchers measure

Primary outcomes

  1. Changes in skin reaction development

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

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

Secondary outcomes

  1. Pain

    Time frame: Immediately after IPL exposure (approx. 2 min)

Other outcomes

  1. mRNA expression of pigment markers

    Time frame: 16-24 hrs after the first IPL exposure

07

Study locations

1 site
  • Bispebjerg Hospital
    Copenhagen, Bispebjerg 2400, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01763723
Lead sponsor
Bispebjerg Hospital
Responsible party
Christina Haak (MD., Bispebjerg Hospital) — Principal investigator
First posted
Jan 9, 2013
Start date
Apr 2012
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Jul 31, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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