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

NCT ID: NCT01763723

Last Updated: 2015-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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IPL after UV-exposure

8 UV-exposures followed by 3 weekly IPL exposures

Group Type EXPERIMENTAL

IPL-home use device

Intervention Type DEVICE

A light based home use device for hair removal

Interventions

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IPL-home use device

A light based home use device for hair removal

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christina Haak

MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bispebjerg Hospital

Copenhagen, Bispebjerg, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-1-2012-025

Identifier Type: -

Identifier Source: org_study_id

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