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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01529996
First received: February 7, 2012
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Rosacea
Procedure: Pulse Dye Laser/YAG laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Rating on global improvement scale [ Time Frame: four months ] [ Designated as safety issue: No ]
    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 [ Time Frame: four months ] [ Designated as safety issue: No ]
    Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit


Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: four months ] [ Designated as safety issue: No ]
    Patients will record satisfaction on the questionnaires provided

  • Recorded discomfort [ Time Frame: four months ] [ Designated as safety issue: No ]
    Subjects will record discomfort using a 10-point scale

  • Adverse events [ Time Frame: four months ] [ Designated as safety issue: Yes ]
    Any adverse events will be recorded


Enrollment: 16
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529996

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT01529996     History of Changes
Other Study ID Numbers: STU55489
Study First Received: February 7, 2012
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014