Pulsed Dye Laser (PDL) vs. Microsecond 1064-nm Nd:YAG Laser for Treatment of Diffuse Facial Redness

Comparison of the Efficacy Between Pulsed Dye Laser (PDL) and the Microsecond 1064-nm Nd:YAG Laser for Treatment of Diffuse Facial Redness: A Pilot, Prospective Randomized Trial.

The primary objective of this study is to compare the efficacy of PDL and the 1064-nm Nd:YAG laser in the treatment of facial redness.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Procedure: Pulse Dye Laser/YAG laser

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy patients 18-55 years of age with erythematotelangiectatic rosacea (as verified by the the PI).
• Subjects who are willing to provide informed consent for participation in the study.

Exclusion Criteria:

• Pregnant or lactating individuals
• Subjects who are unable to understand the protocol or to give informed consent.
• Subjects who have a known history of photosensitive conditions (e.g. Systemic lupus, polymorphous light eruption)
• Subjects who have facial telangiectasia of diameter greater than 2 mm.
• Subject who have significant (as determined by the PI) acute inflammatory papules, pustules, and vesicle involving the central face.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YAG laser	Procedure: Pulse Dye Laser/YAG laser; This study involves treatments with two types of lasers, Pulsed dye lasers (PDL) and the 1064 nm Nd: YAG. Both lasers are FDA approved to treat vascularities in the skin.
Active Comparator: Pulse Dye Laer	Procedure: Pulse Dye Laser/YAG laser; This study involves treatments with two types of lasers, Pulsed dye lasers (PDL) and the 1064 nm Nd: YAG. Both lasers are FDA approved to treat vascularities in the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rating on global improvement scale	Non-treating dermatologists will rate each side of the face using a global improvement scale to evaluate the effectiveness of the two treatments.	four months
Spectrophotometer measurement	Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit	four months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patients will record satisfaction on the questionnaires provided	four months
Recorded discomfort	Subjects will record discomfort using a 10-point scale	four months
Adverse events	Any adverse events will be recorded	four months

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: February 7, 2012
• First Submitted That Met QC Criteria: February 8, 2012
• First Posted (Estimate): February 9, 2012

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: STU55489