Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Radiotherapy, an essential modality in cancer treatment, frequently induces a fibrotic process in the skin which can lead to increased risk of malignancy, poor wound healing, pain and limitation of movement, and permanent loss of skin appendages with hyper/hypopigmentation, decreased sweating and xerosis, posing significant cosmetic and quality of life issues. Advances in laser therapy has led to the use of fractional laser treatment (FLT) to treat fibrosis associated with in hypertrophic scars and morphea, leading to tissue repair, scar remodeling. The investigators propose a pilot clinical study to test the hypothesis that FLT can normalize the fibrotic process and induce normal scar remodeling in patients affected by chronic radiation injury. Understanding and correcting this underlying fibrotic process can help restore normal skin functions in patients affected with chronic radiation dermatitis (RD) and other debilitating fibrotic diseases in dermatology such as scleroderma, morphea, or nephrogenic systemic fibrosis.
We propose to treat 22 patients with significant radiation induced fibrosis (RIF) and skin changes. Each patient will receive fractional treatment (FLT) using the Lumenis Ultrapulse Carbon Dioxide (CO2) laser as well as control (no treatment) randomized to site. Patient age, type of cancer, method/dosage of radiation, latency between radiation treatment and start of study, and characteristics of skin changes will be recorded, including fibrosis surface area, depth, color, and compliance. Assessments will be conducted before each treatment, after each treatment, and 3-12 months after the last treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional CO2 laser Treatment | Experimental | This is the area getting treated with CO2 laser. |
|
| No Treatment | Experimental | This is the area receiving no treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional CO2 laser treatment | Device | Patient will be treated with fractional laser treatment over the areas with fibrosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in fibrosis (% reduction in fibrosis surface area) compared to controlled sites | The primary end point is % reduction of the fibrosis surface area compared to control sites at 6-12 months. | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Measurement adverse events (infection, scarring, ulceration, excessive bleeding, poor wound healing) | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard R Anderson, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellman Center for Photomedicine, Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Not provided
| Label | URL |
|---|---|
| clinical trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D005355 | Fibrosis |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No treatment | Other | Patient will also have an area that is not being treated with CO2 laser. This is the area not getting treatment. |
|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |