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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Rosacea

Intervention / Treatment
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* Procedure: Pulse Dye Laser/YAG laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YAG laser<br> | Procedure: Pulse Dye Laser/YAG laser<br>* 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.<br>|
| Active Comparator: Pulse Dye Laer<br> | Procedure: Pulse Dye Laser/YAG laser<br>* 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.<br>|

What is the study measuring?
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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 |