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

Rosacea Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529996
• Other study ID #: STU55489
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: November 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rosacea

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Spectrophotometer measurement	Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit	four months
Secondary	Patient satisfaction	Patients will record satisfaction on the questionnaires provided	four months
Secondary	Recorded discomfort	Subjects will record discomfort using a 10-point scale	four months
Secondary	Adverse events	Any adverse events will be recorded	four months