Pigment-Tan-Safety Study of a Light-based Home Device for... | NCT01763723

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

NCT01763723

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Jul 31, 2015Estimated

Enrollment

21Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

IPL-home use device

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Dec 20, 2012

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IPL after UV-exposure	Experimental	8 UV-exposures followed by 3 weekly IPL exposures	Device: IPL-home use device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IPL-home use device	Device	A light based home use device for hair removal	IPL after UV-exposure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pain		Immediately after IPL exposure (approx. 2 min)

Other Outcomes

Measure	Description	Time Frame
mRNA expression of pigment markers		16-24 hrs after the first IPL exposure

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Copenhagen	Bispebjerg	2400	Denmark