Side Effects of Q-Switched Ruby Laser for the Treatment o... | NCT00386204

Studies
Side Effects of Q-Switched Ruby Laser for the Treatment of Lentigines in Light and Dark Skin Types

NCT00386204

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Jun 4, 2008Estimated

Enrollment

Phase

Phase 2

Conditions

Solar Lentigines

Interventions

Q-switched Ruby Laser

Countries

Iran

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

Jun 2008

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

Nov 2005

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Oct 10, 2006

First Submission Date that Met QC Criteria

Oct 10, 2006

First Posted Date

Oct 11, 2006Estimated

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

Jun 2, 2008

Last Update Posted Date

Jun 4, 2008Estimated

Description Module

Brief Summary

The purpose of this study is a comparison of efficacy and side effects of Q-switched Ruby laser treatment for solar lentigines in two different skin types II and IV.

Detailed Description

It has been widely accepted that dark colored individuals are prone to develop laser induced side effects especially post inflammatory hyperpigmentation(PIH) and it could be a limiting issue in selecting dark colored individuals.

We designed this study to evaluate the difference of efficacy and side effects in light and dark skinned individuals.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Q-switched Ruby Laser	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Solar Lentigines
Fitzpatrick skin type II and IV

Exclusion Criteria:

Pregnancy
Age above 80
Photosensitivity
Concern for malignancy
Active Infection

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Parviz Toossi, M.D.	Shahid Beheshti University of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Skin Research Center, Shohada-e Tajrish Hospital, Shaheed Beheshti Medical University		Tehran	Tehran Province	19899	Iran

Measure	Description	Time Frame
Clinical Clearance
Side Effects