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

This study has been completed.

Sponsored by:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00386204

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
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 Shaheed 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

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

Shaheed Beheshti Medical University

Investigators

Study Chair:

Parviz Toossi, M.D.

Shaheed Beheshti Medical University

More Information

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

Keywords provided by Shaheed Beheshti Medical University:

Q-switched Ruby laser

Study placed in the following topic categories:

Hyperpigmentation
Lentigo
Skin Diseases
Pigmentation Disorders
Melanosis

ClinicalTrials.gov processed this record on January 16, 2009