Pilot Study of the Effect of Laser on Reversing Chronic Radiation Injury
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|ClinicalTrials.gov Identifier: NCT01910818|
Recruitment Status : Recruiting
First Posted : July 30, 2013
Last Update Posted : January 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Radiation Dermatitis||Device: Fractional CO2 laser treatment Other: No treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Understanding and Reversing Chronic Radiation Dermatitis - A Pilot Study|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Fractional CO2 laser Treatment
This is the area getting treated with CO2 laser.
Device: Fractional CO2 laser treatment
Patient will be treated with fractional laser treatment over the areas with fibrosis.
Other Name: Lumenis Ultrapulse CO2 laser
Experimental: No Treatment
This is the area receiving no treatment.
Other: No treatment
Patient will also have an area that is not being treated with CO2 laser. This is the area not getting treatment.
- Improvement in fibrosis (% reduction in fibrosis surface area) compared to controlled sites [ Time Frame: 6-12 months ]The primary end point is % reduction of the fibrosis surface area compared to control sites at 6-12 months.
- Adverse events [ Time Frame: 2 years ]Measurement adverse events (infection, scarring, ulceration, excessive bleeding, poor wound healing)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910818
|Contact: Richard R Anderson, MDfirstname.lastname@example.org|
|Contact: Thanh-Nga Tran, MD PhDemail@example.com|
|United States, Massachusetts|
|Wellman Center for Photomedicine, Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Richard R Anderson, MD 617-726-3308 firstname.lastname@example.org|
|Contact: Thanh-Nga T Tran, MD PhD 617-724-4937 email@example.com|
|Principal Investigator: Richard R Anderson, MD|
|Sub-Investigator: Thanh-Nga T. Tran, MD PhD|
|Sub-Investigator: Yen-Lin Chen, MD|
|Principal Investigator:||Richard R Anderson, MD||Massachusetts General Hospital|