NCT01529996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

February 7, 2012

Last Update Submit

November 30, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Patient satisfaction

    four months

  • Recorded discomfort

    four months

  • Adverse events

    four months

Study Arms (2)

YAG laser

EXPERIMENTAL
Procedure: Pulse Dye Laser/YAG laser

Pulse Dye Laer

ACTIVE COMPARATOR
Procedure: Pulse Dye Laser/YAG laser

Interventions

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.

Pulse Dye LaerYAG laser

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Murad Alam, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 9, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations