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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00386204
First received: October 10, 2006
Last updated: June 2, 2008
Last verified: June 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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 Medical University:

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

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Medical University
Investigators
Study Chair: Parviz Toossi, M.D. Shahid Beheshti Medical University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00386204     History of Changes
Other Study ID Numbers: src-pts-11073
Study First Received: October 10, 2006
Last Updated: June 2, 2008
Health Authority: Iran: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 15, 2014