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

Primary Purpose

Rosacea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pulse Dye Laser/YAG laser

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

YAG laser

Pulse Dye Laer

Arm Description

Outcomes

Primary Outcome Measures

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.

Spectrophotometer measurement

Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit

Secondary Outcome Measures

Patient satisfaction

Patients will record satisfaction on the questionnaires provided

Recorded discomfort

Subjects will record discomfort using a 10-point scale

Adverse events

Any adverse events will be recorded

Full Information

NCT ID

NCT01529996

First Posted

February 7, 2012

Last Updated

November 30, 2021

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT01529996

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosacea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

YAG laser

Arm Type

Experimental

Arm Title

Pulse Dye Laer

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Pulse Dye Laser/YAG laser

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rating on global improvement scale

Description

Non-treating dermatologists will rate each side of the face using a global improvement scale to evaluate the effectiveness of the two treatments.

Time Frame

four months

Title

Spectrophotometer measurement

Description

Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit

Time Frame

four months

Secondary Outcome Measure Information:

Title

Patient satisfaction

Description

Patients will record satisfaction on the questionnaires provided

Time Frame

four months

Title

Recorded discomfort

Description

Subjects will record discomfort using a 10-point scale

Time Frame

four months

Title

Adverse events

Description

Any adverse events will be recorded

Time Frame

four months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Murad Alam, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine, Department of Dermatology

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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