- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00306371
Comparison of Stacked-Pulses Vs. Double-Pass Treatments of Facial Acne With a 1450 Nm Laser
March 22, 2006 updated by: Skincare Physicians of Chestnut Hill
Acne can be treated with a mid-infrared laser.
We demonstrated safety and efficacy using lower energy settings in order to make the treatments less painful
Study Overview
Detailed Description
Numerous light based therapies are currently being used for the treatment of acne.
Non-ablative mid-infrared lasers have the advantage of decreasing inflammatory acne and improving acne scars.
Specifically, the 1450 nm laser has been shown to be quite effective.
However, it is associated with considerable pain at higher fluences despite topical anesthetics, especially when treating inflammatory acne.
The goal of this study was to determine the possibility of using low fluence settings to treat moderate to severe acne at a more tolerable pain level without compromising treatment effectiveness.
Study Type
Observational
Enrollment
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Chestnut Hill, Massachusetts, United States, 02467
- SkinCare Physicians of Chestnut Hill
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- acne lesion count of at least 10 inflammatory papules on each side of the face and a severity grade consistent with color photographs in the Allen & Smith grading scale of greater than or equal to grade 3 and no worse than grade 5
Exclusion Criteria:
- Exclusion criteria included the use of oral retinoids or systemic corticosteroids within the past 6 months and the use of all prescription topical or systemic anti-acne medications 4 weeks prior to the initiation of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Nathan S Uebelhoer, DO, SkinCare Physicians of Chestnut Hill
- Study Director: Jeffrey S Dover, MD, SkinCare Physicians of Chestnut Hill
- Study Chair: Kenneth A Arndt, MD, SkinCare Physicians of Chestnut Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion
December 7, 2022
Study Completion
February 1, 2006
Study Registration Dates
First Submitted
March 22, 2006
First Submitted That Met QC Criteria
March 22, 2006
First Posted (Estimate)
March 23, 2006
Study Record Updates
Last Update Posted (Estimate)
March 23, 2006
Last Update Submitted That Met QC Criteria
March 22, 2006
Last Verified
July 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20040308
- WIRB study # 1056817
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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