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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386204
First Posted: October 11, 2006
Last Update Posted: June 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Solar Lentigines Device: Q-switched Ruby Laser Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Efficacy and Side Effects of Q-Switched Ruby Laser Treatment of Solar Lentigines in Two Different Fitzpatrick Skin Types II and IV

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Clinical Clearance
  • Side Effects

Estimated Enrollment: 90
Study Start Date: November 2005
Estimated Study Completion Date: September 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Solar Lentigines
  • Fitzpatrick skin type II and IV

Exclusion Criteria:

  • Pregnancy
  • Age above 80
  • Photosensitivity
  • Concern for malignancy
  • Active Infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386204


Locations
Iran, Islamic Republic of
Skin Research Center, Shohada-e Tajrish Hospital, Shaheed Beheshti Medical University
Tehran, Iran, Islamic Republic of, 19899
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Study Chair: Parviz Toossi, M.D. Shahid Beheshti University of Medical Sciences
  More Information

ClinicalTrials.gov Identifier: NCT00386204     History of Changes
Other Study ID Numbers: src-pts-11073
First Submitted: October 10, 2006
First Posted: October 11, 2006
Last Update Posted: June 4, 2008
Last Verified: June 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
Q-switched Ruby laser

Additional relevant MeSH terms:
Lentigo
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases