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

Solar Lentigines Clinical Trial

Official title:

Efficacy and Side Effects of Q-Switched Ruby Laser Treatment of Solar Lentigines in Two Different Fitzpatrick Skin Types II and IV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386204
• Other study ID #: src-pts-11073
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2006
• Last updated: June 2, 2008
• Start date: November 2005
• Est. completion date: September 2006

Study information

• Verified date: June 2008
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• Solar Lentigines

• Fitzpatrick skin type II and IV

Exclusion Criteria:

• Pregnancy

• Age above 80

• Photosensitivity

• Concern for malignancy

• Active Infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lentigo
• Solar Lentigines

Intervention

Device:
• Q-switched Ruby Laser

Locations

Country	Name	City	State
Iran, Islamic Republic of	Skin Research Center, Shohada-e Tajrish Hospital, Shaheed Beheshti Medical University	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Clearance
Primary	Side Effects