RosaceaNCT01529996
Pulsed Dye Laser (PDL) vs. Microsecond 1064-nm Nd:YAG Laser for Treatment of Diffuse Facial Redness
A study testing Pulse Dye Laser/YAG laser in people with Rosacea, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Pulse Dye Laser/YAG laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
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.
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.
- Conditions
- Rosacea
- Being tested
- Pulse Dye Laser/YAG laser
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Dye Laser/YAG laserProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| YAG laser | Experimental | Not described Receives: Procedure: Pulse Dye Laser/YAG laser |
| Pulse Dye Laer | Active comparator | Not described Receives: Procedure: Pulse Dye Laser/YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: four months
Spectrophotometer measurement
Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit
Measured: four months
Secondary outcomes (3)
Patient satisfaction
Patients will record satisfaction on the questionnaires provided
Measured: four months
Recorded discomfort
Subjects will record discomfort using a 10-point scale
Measured: four months
Adverse events
Any adverse events will be recorded
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529996
- Sponsor's protocol ID
- STU55489
- Status last verified
- Nov 2021
- First submitted
- 7 Feb 2012
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01529996
- Acronym / sponsor ID
- STU55489
- Conditions
- Rosacea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YAG laser | Experimental | Procedure: Pulse Dye Laser/YAG laser |
| Pulse Dye Laer | Active comparator | Procedure: Pulse Dye Laser/YAG laser |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse Dye Laser/YAG laserThis 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. | Procedure or surgery | Pulse Dye Laer, YAG laser |
Primary outcome
Rating on global improvement scale
Time frame: four months
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
Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit
3 secondary outcomes
Patient satisfaction
Time frame: four months
Recorded discomfort
Time frame: four months
Adverse events
Time frame: four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse Dye Laser/YAG laser in people with Rosacea, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rating on global improvement scale (time frame: four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.