LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis: A Prospective, Randomized, Controlled Study
At the recent ASDS meeting in Chicago, Douglas Fife, M.D., presented preliminary findings from a study conducted with investigators from the University of California, Irvine, Departments of Dermatology and Radiation Oncology concerning the use of LED photomodulation to prevent post-radiation treatment dermatitis, which occurs in an estimated 75% to 87% of breast cancer patients who receive radiation therapy.
Study
Authors proposed that LED photomodulation might provide a method to reduce suffering associated with radiation treatments, improve cosmetic outcome of skin in radiation fields, and eliminate breaks in radiation treatments resulting from severe radiation dermatitis.
Hypothesis Tested
Investigators sought to test the hypothesis that LED photomodulation treatments administered before and after each radiation therapy session would result in decreased grade 2 and 3 radiation dermatitis, as measured at 5 weeks. Secondary outcome measures included fewer interruptions of radiation therapy, improved patient satisfaction, and improved post-radiation treatment appearance of the skin.
Methods
This study, which involved 40 post-lumpectomy or post-mastectomy breast cancer patients, was reviewed and approved by the Institutional Review Board at the University of California, Irvine. Participants were randomly assigned to either a treatment group or to a control group, with the treatment group assigned to receive LED photomodulation treatments before and after each radiation treatment with the Gentlewaves Select handheld high-energy 590 nm LED array using specific sequences of pulses used in other studies. This group was also to receive seven additional treatments over 2 weeks after their radiation treatment course was completed. The control group protocol involved “sham” treatments in which no light was administered, but the exact same skincare regimen used by the treatment group was followed. In addition to weekly evaluation and grading of skin reactions, patients were photographed weekly under standardized conditions and photographs were evaluated and graded using a blinded method by dermatologists.
Preliminary Results
Due to administrative review delays, only nine patients have enrolled in the study to date, and three patients (two in the treatment group, one in the control) completed the entire protocol. Among these three patients, investigators report neither statistically significant findings nor anecdotally noted differences in their skin reactions.
As the study continues, the authors plan to test their hypothesis on a patient with bilateral breast cancer who will be receiving radiation therapy to both breasts. One of her breasts will receive LED therapy, while the other breast will not and will therefore be a “self-control.”
Study authors: Douglas Fife, M.D., Shahdad, Behnam, M.D.; Kristen M. Kelly, M.D.; Christopher Zachary, M.B.B.S., FRCP; Nilam Ramsinghani, M.D.; Jeffrey Kuo, M.D.; Laila Elkeeb, M.D.; David Rayhan, M.S.
Assessment of the Effect of Injection Techniques on the Rate of Local Adverse Events Using Hyaluronic Acid Gel Dermal Fillers
A poster presented at the American Society of Dermatologic Surgery was based on a study undertaken by Richard G. Glogau, M.D., Clinical Professor of Dermatology, University of California, San Francisco, to learn more about the relationship between hyaluronic acid (HA) dermal fillers and the rate and variability of local adverse events possibly caused by injection technique and needle trauma as opposed to the intrinsic chemical composition of the dermal filler.
Study Description
This prospective, controlled study purposed to evaluate the effect of injection technique on the occurrence of local adverse events during implantation of hyaluronic acid gel particle fillers.
It involved 283, randomly assigned ethnically diverse patients with moderate-to-severe nasolabial folds (NLFs) and marionette lines. Patients received midface injections of one of two lightly cross-linked hyaluronic gel fillers: Restylane (smaller gel particles) or Perlane (larger gel particles).
Investigators could use different injection techniques for this study. Touch-up treatments were allowed at 2 weeks. Subjects were assessed for local adverse events (e.g., erythema, ecchymosis, edema, itching, pain, tenderness) at 72 hours and at 2, 6, 12, and 24 weeks. Data collected included physician experience, time taken to correct a specific wrinkle, depth of injection, volume used to correct a specific wrinkle, number of injection sessions required to correct a specific wrinkle (initial and/or 2-week touch-up), and investigator method of injection (e.g., linear threading, multiple puncture, or use of fanning needle after dermal penetration). As required in the statistical analysis plan, assessment variables were pre-assigned a correlate to the rate of local adverse events.
Results
Initial results showed that the rate of adverse events was not significant at any time point for the number of sessions required to correct a specific wrinkle, years of physician experience, or Perlane vs. Restylane.
Based upon these initial results, the remaining variables were evaluated using pooled data and logistic regression. Increased safety was significantly associated with the avoidance of fanlike injection, lower volumes per site, and slower injection technique (P<.0001).
Due to the linear relationship between volume and time and the interrelationship of their effect, volume/time was added to the logistic regression to assess the impact of flow on adverse reactions.
Because flow was not directly measured, the analysis was restricted to flow rates below 1.4 ml/min, which prevented the masking of episodic high flows by overall long injection periods. Flow rates below 0.3 ml/min were found to significantly reduce local adverse events (odds ratio <0.3).
Conclusion
The product safety profiles of the NASHA gel particle fillers Restylane and Perlane were identical. They had comparable local adverse event profiles, with the majority of reactions characterized as bruising and edema. There was no significant association between number of injections required to correct a specific wrinkle or years of physician experience and rate of local adverse events.
However, significantly higher rates of local adverse events were noted for fanlike injection techniques and high injection flow rates that dissected the subepidermal plane.
These results suggest that optimal outcomes and improved tolerability can be achieved with slow, steady injections along the needle trajectory
A New Wrinkle and Fold Grading System for Facial Volumization and Restoration
A poster presented at the American Society for Dermatologic Surgery described a study undertaken to develop an easy-to-use grading system for the evaluation of facial folds and creases to optimize patient outcomes in facial volumization and restoration. In addition to creating a system that would aid communication and in the management of patient expectations, the study sought to calculate the appropriate amount of dermal filler required to create specific facial corrections.
The Grading System
This system defines five levels of severity, which specifically address the length, width and depth of folds and creases, as well as volume loss in different facial zones including the glabella, nasolabial fold, marionette and prejowl sulcus.
In addition, recommendations for amounts of dermal filler required for each procedure were also provided.
Patients
The study included over 250 patients age 35 to 70. Among them, 10% to 12% were level 1 patients; 25% to 30% were level 2 patients; 30% to 40% were level 3 patients; 25% to 30% were level 4 patients; and 10% to 12% were level 5 patients.
Study Design
After patients and physicians met and the replacement procedure was described, patients’ faces were evaluated and photographed. The procedure was completed, then photographed on the first side of the face; then the procedure was completed and photographed on the other side. The amount and type of filler were predetermined based on the length, width and depth of the folds treated combined with the volume loss in that zone.
Although this grading system was developed for all zones of the face, poster findings focused upon the use of the grading system for treating the marionette and prejowl sulcus zones of women.
Conclusions
According to the author, the grading system offered practical benefits to both physicians and their patients.
It supported patient awareness, which was helpful in setting appropriate patient expectations concerning outcomes.
It enabled practitioners to properly evaluate the length, width and depth of the folds or creases as well as the amount of volume loss in each facial zone so they could inject the appropriate amount of dermal filler for each specific procedure performed.
Using the specified amount of Perlane and Restylane maximized clinical results, which resulted in greater patient satisfaction. In addition, injecting the appropriate amount of Perlane and Restylane to restore volume added longevity to the correction with lesser amounts of touch-up material required in the future.
LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis: A Prospective, Randomized, Controlled Study
At the recent ASDS meeting in Chicago, Douglas Fife, M.D., presented preliminary findings from a study conducted with investigators from the University of California, Irvine, Departments of Dermatology and Radiation Oncology concerning the use of LED photomodulation to prevent post-radiation treatment dermatitis, which occurs in an estimated 75% to 87% of breast cancer patients who receive radiation therapy.
Study
Authors proposed that LED photomodulation might provide a method to reduce suffering associated with radiation treatments, improve cosmetic outcome of skin in radiation fields, and eliminate breaks in radiation treatments resulting from severe radiation dermatitis.
Hypothesis Tested
Investigators sought to test the hypothesis that LED photomodulation treatments administered before and after each radiation therapy session would result in decreased grade 2 and 3 radiation dermatitis, as measured at 5 weeks. Secondary outcome measures included fewer interruptions of radiation therapy, improved patient satisfaction, and improved post-radiation treatment appearance of the skin.
Methods
This study, which involved 40 post-lumpectomy or post-mastectomy breast cancer patients, was reviewed and approved by the Institutional Review Board at the University of California, Irvine. Participants were randomly assigned to either a treatment group or to a control group, with the treatment group assigned to receive LED photomodulation treatments before and after each radiation treatment with the Gentlewaves Select handheld high-energy 590 nm LED array using specific sequences of pulses used in other studies. This group was also to receive seven additional treatments over 2 weeks after their radiation treatment course was completed. The control group protocol involved “sham” treatments in which no light was administered, but the exact same skincare regimen used by the treatment group was followed. In addition to weekly evaluation and grading of skin reactions, patients were photographed weekly under standardized conditions and photographs were evaluated and graded using a blinded method by dermatologists.
Preliminary Results
Due to administrative review delays, only nine patients have enrolled in the study to date, and three patients (two in the treatment group, one in the control) completed the entire protocol. Among these three patients, investigators report neither statistically significant findings nor anecdotally noted differences in their skin reactions.
As the study continues, the authors plan to test their hypothesis on a patient with bilateral breast cancer who will be receiving radiation therapy to both breasts. One of her breasts will receive LED therapy, while the other breast will not and will therefore be a “self-control.”
Study authors: Douglas Fife, M.D., Shahdad, Behnam, M.D.; Kristen M. Kelly, M.D.; Christopher Zachary, M.B.B.S., FRCP; Nilam Ramsinghani, M.D.; Jeffrey Kuo, M.D.; Laila Elkeeb, M.D.; David Rayhan, M.S.
Assessment of the Effect of Injection Techniques on the Rate of Local Adverse Events Using Hyaluronic Acid Gel Dermal Fillers
A poster presented at the American Society of Dermatologic Surgery was based on a study undertaken by Richard G. Glogau, M.D., Clinical Professor of Dermatology, University of California, San Francisco, to learn more about the relationship between hyaluronic acid (HA) dermal fillers and the rate and variability of local adverse events possibly caused by injection technique and needle trauma as opposed to the intrinsic chemical composition of the dermal filler.
Study Description
This prospective, controlled study purposed to evaluate the effect of injection technique on the occurrence of local adverse events during implantation of hyaluronic acid gel particle fillers.
It involved 283, randomly assigned ethnically diverse patients with moderate-to-severe nasolabial folds (NLFs) and marionette lines. Patients received midface injections of one of two lightly cross-linked hyaluronic gel fillers: Restylane (smaller gel particles) or Perlane (larger gel particles).
Investigators could use different injection techniques for this study. Touch-up treatments were allowed at 2 weeks. Subjects were assessed for local adverse events (e.g., erythema, ecchymosis, edema, itching, pain, tenderness) at 72 hours and at 2, 6, 12, and 24 weeks. Data collected included physician experience, time taken to correct a specific wrinkle, depth of injection, volume used to correct a specific wrinkle, number of injection sessions required to correct a specific wrinkle (initial and/or 2-week touch-up), and investigator method of injection (e.g., linear threading, multiple puncture, or use of fanning needle after dermal penetration). As required in the statistical analysis plan, assessment variables were pre-assigned a correlate to the rate of local adverse events.
Results
Initial results showed that the rate of adverse events was not significant at any time point for the number of sessions required to correct a specific wrinkle, years of physician experience, or Perlane vs. Restylane.
Based upon these initial results, the remaining variables were evaluated using pooled data and logistic regression. Increased safety was significantly associated with the avoidance of fanlike injection, lower volumes per site, and slower injection technique (P<.0001).
Due to the linear relationship between volume and time and the interrelationship of their effect, volume/time was added to the logistic regression to assess the impact of flow on adverse reactions.
Because flow was not directly measured, the analysis was restricted to flow rates below 1.4 ml/min, which prevented the masking of episodic high flows by overall long injection periods. Flow rates below 0.3 ml/min were found to significantly reduce local adverse events (odds ratio <0.3).
Conclusion
The product safety profiles of the NASHA gel particle fillers Restylane and Perlane were identical. They had comparable local adverse event profiles, with the majority of reactions characterized as bruising and edema. There was no significant association between number of injections required to correct a specific wrinkle or years of physician experience and rate of local adverse events.
However, significantly higher rates of local adverse events were noted for fanlike injection techniques and high injection flow rates that dissected the subepidermal plane.
These results suggest that optimal outcomes and improved tolerability can be achieved with slow, steady injections along the needle trajectory
A New Wrinkle and Fold Grading System for Facial Volumization and Restoration
A poster presented at the American Society for Dermatologic Surgery described a study undertaken to develop an easy-to-use grading system for the evaluation of facial folds and creases to optimize patient outcomes in facial volumization and restoration. In addition to creating a system that would aid communication and in the management of patient expectations, the study sought to calculate the appropriate amount of dermal filler required to create specific facial corrections.
The Grading System
This system defines five levels of severity, which specifically address the length, width and depth of folds and creases, as well as volume loss in different facial zones including the glabella, nasolabial fold, marionette and prejowl sulcus.
In addition, recommendations for amounts of dermal filler required for each procedure were also provided.
Patients
The study included over 250 patients age 35 to 70. Among them, 10% to 12% were level 1 patients; 25% to 30% were level 2 patients; 30% to 40% were level 3 patients; 25% to 30% were level 4 patients; and 10% to 12% were level 5 patients.
Study Design
After patients and physicians met and the replacement procedure was described, patients’ faces were evaluated and photographed. The procedure was completed, then photographed on the first side of the face; then the procedure was completed and photographed on the other side. The amount and type of filler were predetermined based on the length, width and depth of the folds treated combined with the volume loss in that zone.
Although this grading system was developed for all zones of the face, poster findings focused upon the use of the grading system for treating the marionette and prejowl sulcus zones of women.
Conclusions
According to the author, the grading system offered practical benefits to both physicians and their patients.
It supported patient awareness, which was helpful in setting appropriate patient expectations concerning outcomes.
It enabled practitioners to properly evaluate the length, width and depth of the folds or creases as well as the amount of volume loss in each facial zone so they could inject the appropriate amount of dermal filler for each specific procedure performed.
Using the specified amount of Perlane and Restylane maximized clinical results, which resulted in greater patient satisfaction. In addition, injecting the appropriate amount of Perlane and Restylane to restore volume added longevity to the correction with lesser amounts of touch-up material required in the future.
LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis: A Prospective, Randomized, Controlled Study
At the recent ASDS meeting in Chicago, Douglas Fife, M.D., presented preliminary findings from a study conducted with investigators from the University of California, Irvine, Departments of Dermatology and Radiation Oncology concerning the use of LED photomodulation to prevent post-radiation treatment dermatitis, which occurs in an estimated 75% to 87% of breast cancer patients who receive radiation therapy.
Study
Authors proposed that LED photomodulation might provide a method to reduce suffering associated with radiation treatments, improve cosmetic outcome of skin in radiation fields, and eliminate breaks in radiation treatments resulting from severe radiation dermatitis.
Hypothesis Tested
Investigators sought to test the hypothesis that LED photomodulation treatments administered before and after each radiation therapy session would result in decreased grade 2 and 3 radiation dermatitis, as measured at 5 weeks. Secondary outcome measures included fewer interruptions of radiation therapy, improved patient satisfaction, and improved post-radiation treatment appearance of the skin.
Methods
This study, which involved 40 post-lumpectomy or post-mastectomy breast cancer patients, was reviewed and approved by the Institutional Review Board at the University of California, Irvine. Participants were randomly assigned to either a treatment group or to a control group, with the treatment group assigned to receive LED photomodulation treatments before and after each radiation treatment with the Gentlewaves Select handheld high-energy 590 nm LED array using specific sequences of pulses used in other studies. This group was also to receive seven additional treatments over 2 weeks after their radiation treatment course was completed. The control group protocol involved “sham” treatments in which no light was administered, but the exact same skincare regimen used by the treatment group was followed. In addition to weekly evaluation and grading of skin reactions, patients were photographed weekly under standardized conditions and photographs were evaluated and graded using a blinded method by dermatologists.
Preliminary Results
Due to administrative review delays, only nine patients have enrolled in the study to date, and three patients (two in the treatment group, one in the control) completed the entire protocol. Among these three patients, investigators report neither statistically significant findings nor anecdotally noted differences in their skin reactions.
As the study continues, the authors plan to test their hypothesis on a patient with bilateral breast cancer who will be receiving radiation therapy to both breasts. One of her breasts will receive LED therapy, while the other breast will not and will therefore be a “self-control.”
Study authors: Douglas Fife, M.D., Shahdad, Behnam, M.D.; Kristen M. Kelly, M.D.; Christopher Zachary, M.B.B.S., FRCP; Nilam Ramsinghani, M.D.; Jeffrey Kuo, M.D.; Laila Elkeeb, M.D.; David Rayhan, M.S.
Assessment of the Effect of Injection Techniques on the Rate of Local Adverse Events Using Hyaluronic Acid Gel Dermal Fillers
A poster presented at the American Society of Dermatologic Surgery was based on a study undertaken by Richard G. Glogau, M.D., Clinical Professor of Dermatology, University of California, San Francisco, to learn more about the relationship between hyaluronic acid (HA) dermal fillers and the rate and variability of local adverse events possibly caused by injection technique and needle trauma as opposed to the intrinsic chemical composition of the dermal filler.
Study Description
This prospective, controlled study purposed to evaluate the effect of injection technique on the occurrence of local adverse events during implantation of hyaluronic acid gel particle fillers.
It involved 283, randomly assigned ethnically diverse patients with moderate-to-severe nasolabial folds (NLFs) and marionette lines. Patients received midface injections of one of two lightly cross-linked hyaluronic gel fillers: Restylane (smaller gel particles) or Perlane (larger gel particles).
Investigators could use different injection techniques for this study. Touch-up treatments were allowed at 2 weeks. Subjects were assessed for local adverse events (e.g., erythema, ecchymosis, edema, itching, pain, tenderness) at 72 hours and at 2, 6, 12, and 24 weeks. Data collected included physician experience, time taken to correct a specific wrinkle, depth of injection, volume used to correct a specific wrinkle, number of injection sessions required to correct a specific wrinkle (initial and/or 2-week touch-up), and investigator method of injection (e.g., linear threading, multiple puncture, or use of fanning needle after dermal penetration). As required in the statistical analysis plan, assessment variables were pre-assigned a correlate to the rate of local adverse events.
Results
Initial results showed that the rate of adverse events was not significant at any time point for the number of sessions required to correct a specific wrinkle, years of physician experience, or Perlane vs. Restylane.
Based upon these initial results, the remaining variables were evaluated using pooled data and logistic regression. Increased safety was significantly associated with the avoidance of fanlike injection, lower volumes per site, and slower injection technique (P<.0001).
Due to the linear relationship between volume and time and the interrelationship of their effect, volume/time was added to the logistic regression to assess the impact of flow on adverse reactions.
Because flow was not directly measured, the analysis was restricted to flow rates below 1.4 ml/min, which prevented the masking of episodic high flows by overall long injection periods. Flow rates below 0.3 ml/min were found to significantly reduce local adverse events (odds ratio <0.3).
Conclusion
The product safety profiles of the NASHA gel particle fillers Restylane and Perlane were identical. They had comparable local adverse event profiles, with the majority of reactions characterized as bruising and edema. There was no significant association between number of injections required to correct a specific wrinkle or years of physician experience and rate of local adverse events.
However, significantly higher rates of local adverse events were noted for fanlike injection techniques and high injection flow rates that dissected the subepidermal plane.
These results suggest that optimal outcomes and improved tolerability can be achieved with slow, steady injections along the needle trajectory
A New Wrinkle and Fold Grading System for Facial Volumization and Restoration
A poster presented at the American Society for Dermatologic Surgery described a study undertaken to develop an easy-to-use grading system for the evaluation of facial folds and creases to optimize patient outcomes in facial volumization and restoration. In addition to creating a system that would aid communication and in the management of patient expectations, the study sought to calculate the appropriate amount of dermal filler required to create specific facial corrections.
The Grading System
This system defines five levels of severity, which specifically address the length, width and depth of folds and creases, as well as volume loss in different facial zones including the glabella, nasolabial fold, marionette and prejowl sulcus.
In addition, recommendations for amounts of dermal filler required for each procedure were also provided.
Patients
The study included over 250 patients age 35 to 70. Among them, 10% to 12% were level 1 patients; 25% to 30% were level 2 patients; 30% to 40% were level 3 patients; 25% to 30% were level 4 patients; and 10% to 12% were level 5 patients.
Study Design
After patients and physicians met and the replacement procedure was described, patients’ faces were evaluated and photographed. The procedure was completed, then photographed on the first side of the face; then the procedure was completed and photographed on the other side. The amount and type of filler were predetermined based on the length, width and depth of the folds treated combined with the volume loss in that zone.
Although this grading system was developed for all zones of the face, poster findings focused upon the use of the grading system for treating the marionette and prejowl sulcus zones of women.
Conclusions
According to the author, the grading system offered practical benefits to both physicians and their patients.
It supported patient awareness, which was helpful in setting appropriate patient expectations concerning outcomes.
It enabled practitioners to properly evaluate the length, width and depth of the folds or creases as well as the amount of volume loss in each facial zone so they could inject the appropriate amount of dermal filler for each specific procedure performed.
Using the specified amount of Perlane and Restylane maximized clinical results, which resulted in greater patient satisfaction. In addition, injecting the appropriate amount of Perlane and Restylane to restore volume added longevity to the correction with lesser amounts of touch-up material required in the future.
