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

February 7, 2012
September 14, 2012
January 2012
August 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01529996 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Rosacea
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.
  • Experimental: YAG laser
    Intervention: Procedure: Pulse Dye Laser/YAG laser
  • Active Comparator: Pulse Dye Laer
    Intervention: Procedure: Pulse Dye Laser/YAG laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01529996
STU55489
No
Murad Alam, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Murad Alam, MD Northwestern University
Northwestern University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP