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Completed

NCT Number: NCT01763723

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, Bispebjerg, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPL-home use device

Device

A light based home use device for hair removal

Primary outcomes

  1. Changes in skin reaction development

    Time frame: 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 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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2013
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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