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

Primary Purpose

Solar Lentigines

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Q-switched Ruby Laser
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solar Lentigines focused on measuring Q-switched Ruby laser

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Solar Lentigines
  • Fitzpatrick skin type II and IV

Exclusion Criteria:

  • Pregnancy
  • Age above 80
  • Photosensitivity
  • Concern for malignancy
  • Active Infection

Sites / Locations

  • Skin Research Center, Shohada-e Tajrish Hospital, Shaheed Beheshti Medical University

Outcomes

Primary Outcome Measures

Clinical Clearance
Side Effects

Secondary Outcome Measures

Full Information

First Posted
October 10, 2006
Last Updated
June 2, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00386204
Brief Title
Side Effects of Q-Switched Ruby Laser for the Treatment of Lentigines in Light and Dark Skin Types
Official Title
Efficacy and Side Effects of Q-Switched Ruby Laser Treatment of Solar Lentigines in Two Different Fitzpatrick Skin Types II and IV
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solar Lentigines
Keywords
Q-switched Ruby laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Q-switched Ruby Laser
Primary Outcome Measure Information:
Title
Clinical Clearance
Title
Side Effects

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Solar Lentigines Fitzpatrick skin type II and IV Exclusion Criteria: Pregnancy Age above 80 Photosensitivity Concern for malignancy Active Infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parviz Toossi, M.D.
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Skin Research Center, Shohada-e Tajrish Hospital, Shaheed Beheshti Medical University
City
Tehran
ZIP/Postal Code
19899
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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