Chronic Radiation DermatitisNCT01910818
Pilot Study of the Effect of Laser on Reversing Chronic Radiation Injury
A study testing Fractional CO2 laser treatment and No treatment in people with Chronic Radiation Dermatitis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Radiation Dermatitis
- What is being tested?
- Fractional CO2 laser treatment and No treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2026
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females between 18 and 80 years of age with radiation-induced fibrosis and depigmentation. The fibrosis must have occurred at least 1 year prior to the date of enrollment.
- Having suitable areas of treatment: All wounds in the area of interest must be closed for at least two months. The scars must be deemed stable for a period of 3 months or have a suitable contralateral control before initiation of treatment. This will be determined by objective measurements of scar erythema, pliability, induration, thickness at enrollment and again at 3 months;
- Fitzpatrick skin types I-VI;
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements;
- Able to understand and provide written informed consent;
- Pregnant woman can be included because study involves local intervention, no new drugs.
Who cannot join
- Active tanning, including the use of tanning booths, during the course of the study;
- Prior skin treatment with laser or other devices in the treated area within three months of initial treatment or during the course of the study;
- Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
- History of collagen vascular disease;
- Active Herpes Simplex or Zoster at the time of treatment or having experienced more than three episodes of Herpes Simplex / Zoster eruption within a year of study enrollment;
- History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or use of immunosuppressive medications;
Show all 12Show fewer
- Having any form of active cancer at the time of enrollment and during the course of the study;
- Significant concurrent illness, such as uncontrolled diabetes (with a hemoglobin A1C of more than 8) (i.e., any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process); Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
- Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or study personnel) to treat the subject as part of this research study;
- If it is determined that the contracture is due to a deeper process involving the muscles, ligaments or bones.
- Patient on chemotherapy (but not tamoxifen or other things that affect wound healing) and also active XRT
- Participation in another interventional study with potential exposure to an investigational drug within past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Understanding and Reversing Chronic Radiation Dermatitis - A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Chronic Radiation Dermatitis
- Being tested
- Fractional CO2 laser treatment, No treatment
- Keywords
- radiation, dermatitis, laser, fractional, CO2, chronic, fibrosis, scar
- Medical subject headings
- Dermatitis, Bronchiolitis Obliterans Syndrome, Fibrosis, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 laser treatmentDevice
Also called Lumenis Ultrapulse CO2 laser
Patient will be treated with fractional laser treatment over the areas with fibrosis.
No treatmentOther
Patient will also have an area that is not being treated with CO2 laser. This is the area not getting treatment.
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO2 laser Treatment | Experimental | This is the area getting treated with CO2 laser. Receives: Device: Fractional CO2 laser treatment |
| No Treatment | Experimental | This is the area receiving no treatment. Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-12 months
Secondary outcomes (1)
Adverse events
Measurement adverse events (infection, scarring, ulceration, excessive bleeding, poor wound healing)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
- Investigators
- Richard R Anderson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910818
- Sponsor's protocol ID
- 2013P000988
- Status last verified
- Nov 2023
- First submitted
- 5 Jun 2013
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Reversing Chronic Radiation Dermatitis - A Pilot Study
- ClinicalTrials.gov ID
- NCT01910818
- Acronym / sponsor ID
- 2013P000988
- Conditions
- Chronic Radiation Dermatitis
- Keywords
- radiation, dermatitis, laser, fractional, CO2, chronic, fibrosis, scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 30 Jul 2013 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional CO2 laser Treatment | Experimental | Device: Fractional CO2 laser treatmentThis is the area getting treated with CO2 laser. |
| No Treatment | Experimental | Other: No treatmentThis is the area receiving no treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy males and females between 18 and 80 years of age with radiation-induced fibrosis and depigmentation. The fibrosis must have occurred at least 1 year prior to the date of enrollment.
- Having suitable areas of treatment: All wounds in the area of interest must be closed for at least two months. The scars must be deemed stable for a period of 3 months or have a suitable contralateral control before initiation of treatment. This will be determined by objective measurements of scar erythema, pliability, induration, thickness at enrollment and again at 3 months;
- Fitzpatrick skin types I-VI;
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements;
- Able to understand and provide written informed consent;
Key exclusion criteria (12 listed)
- Active tanning, including the use of tanning booths, during the course of the study;
- Prior skin treatment with laser or other devices in the treated area within three months of initial treatment or during the course of the study;
- Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
- History of collagen vascular disease;
- Active Herpes Simplex or Zoster at the time of treatment or having experienced more than three episodes of Herpes Simplex / Zoster eruption within a year of study enrollment;
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 |
|---|---|---|
| Fractional CO2 laser treatmentAlso: Lumenis Ultrapulse CO2 laserPatient will be treated with fractional laser treatment over the areas with fibrosis. | Device | Fractional CO2 laser Treatment |
| No treatmentPatient will also have an area that is not being treated with CO2 laser. This is the area not getting treatment. | Other | No Treatment |
Primary outcome
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.
1 secondary outcome
Adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- clinical trialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Richard R Anderson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional CO2 laser treatment and No treatment in people with Chronic Radiation Dermatitis, run by Massachusetts General Hospital 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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?
Results are not available in the source record.
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?
Improvement in fibrosis (% reduction in fibrosis surface area) compared to controlled sites (time frame: 6-12 months). 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 Nov 2023.