Data from Case Studies Suggesting Superficial Salicylic Acid Peels and Mequinol 2%/tretinoin 0.01% Topical Solution is Safe and Effective for Mild-to-Moderate PIH in Patients of Color
Method
The study population included three female patients, ages 22, 32, and 36, with Fitzpatrick skin types IV-V with mild-to-moderate facial postinflammatory hyperpigmentation (PIH) from acne as rated by the investigator at baseline. For 8 weeks, patients were to continue their regular skin care regimen and follow a sun avoidance/protection program.
Treatment/peel cycles were to include use of mequinol 2%/tretinoin 0.01% solution (applied twice daily, 8 hours apart), which would be discontinued for 3 days prior to the application of a 20% or 30% salicylic acid peel. Treatment with mequinoI 2%/tretinoin 0.01% solution would resume the day following the peel.
Peels would be applied approximately every 4 weeks, as tolerated.
Primary efficacy variables included Physician Global Assessment, Patient Global Assessment and Mexameter evaluation readings of each hyperpigmented target site (as compared to adjacent normal skin.
Conclusion
The case studies provide preliminary data suggesting that a dual modality regimen of superficial salicylic acid peels and mequinol 2%/tretinoin 0.01% topical solution is safe and effective for the treatment of mild-to-moderate PIH in patients with darker skin types.
Poster: Susan C. Taylor, M.D. Case Studies of Combination Treatment With a Solution of Mequinol 2%/Tretinoin 0.01% With Chemical Peels For Mild-To-Moderate Postinflammatory Hyperpigmentation.
Lipodissolve – Is It Safe?
By now, everyone has heard of Lipodissolve, a treatment touted as an alternative to liposuction to banish unwanted fat deposits from various parts of the body. Offered in clinics that have sprouted up throughout the country, this non-FDA-approved procedure involves a series of injections of a mixture of phosphatidylcholine and sodium deoxycholate (PC/DC) said to break down body fat.
The United Kingdom, Brazil and Canada, have banned the procedure, and the Kansas State Board of Healing Arts has been the first medical entity in the United States to do so. However, that decision was subsequently reversed.
Joel Schlessinger, M.D., President of the American Society of Cosmetic Dermatology & Aesthetic Surgery, is concerned.
“What we find with this procedure is that people are injecting a very irritating substance into the body — a combination of a soy product and cow bile — to dissolve the fat. The problem is that it’s become quite popular before any testing, studying or oversight of it by the FDA or any licensing body.”
Dr. Schlessinger says the procedure is being offered in what are called Lipodissolve clinics mainly by non-credentialed individuals who are not qualified to cope with serious complications. There is also a lack of information about how the product works and potential reactions. Dr. Schlessinger has heard of reactions in several patients, ranging from unexplained swelling for 2 years after the procedure to a general malaise that lasted months after a treatment.
“Sadly, this type of situation can be anticipated because this information has not yet been documented in such a new and unproven entity,” he says. “We don’t know how it works, what the process is and how the fat is brought out of the body.”
Dr. Schlessinger does add that the treatment may have merit. “There is some promise to this technology if it is proven safe. Let’s figure that out before people are harmed by something that’s not fully tested before it’s brought to market.”
Hyaluronic Acid-Based Fillers Offer Longer-Lasting Results in Nasolabial Folds Than Cross-Linked Bovine Collagen
Amulticenter, double-blind, randomized, within-subject controlled study used photo-documentation to compare results in nasolabial folds (NLF) treated with cross-linked bovine collagen with new hyaluronic acid-based (HA) fillers.
The study undertaken to document long-term — 8 to 11 months post-treatment — persistence of correction achievable with these fillers demonstrated that HA corrections were longer-lasting.
Methods
This multicenter, double-blind, randomized, within-subject controlled study included subjects with fully visible bilateral nasolabial folds (NLFs) that were moderate or severe (assessed at the deepest part) and were approximately symmetrical and of equal severity on each facial side.
Subjects were randomly assigned to NLF correction with one HA filler (24HV or 30HV) in one NLF and cross-linked bovine collagen filler in the other NLF.
Each study site had two investigators — both specialists in cosmetic dermatology or plastic surgery and experienced in the use of dermal fillers. While the treating investigator could not be masked, the evaluating investigator and the subjects were masked throughout the study.
Up to three treatments received over a 4-week period included initial treatment plus up to two touch-ups approximately 2 weeks apart to achieve optimal correction of the NLFs.
The evaluating investigator assessed the level of correction at 2 and 4 weeks after the initial treatment and, if less than optimal, the treating investigator re-treated the under-corrected NLF(s) with the same assigned filler(s).
Outcome Measures
Subjects were followed at least every 4 weeks for up to 24 weeks after the last treatment and may have had additional follow-up visit(s) if they returned after the end of the study, eg, for a complimentary repeat treatment.
At each visit the appearance of their NLFs was documented using standardized Canfield photography.
The evaluating investigator assessed NLF severity live using the 5-point Wrinkle Assessment Scale together with a validated photographic guide.
In addition, subjects reported their observations of common treatment site reactions on a daily basis from 30 minutes post-injection to day 13 after each treatment including touch-ups. Any additional adverse events reported by the subject or observed by the investigators were also recorded.
Results
Of 292 subjects randomly assigned to treatment with 24HV or 30HV, 280 (96%) completed the 24-week follow-up period. No subjects discontinued due to lack of effectiveness or adverse events.
All three of the fillers (24HV, 30HV, and bovine collagen) achieved statistically significant improvements in NLF severity score at every time point through the 24-week follow-up period. However, the improvements achieved with the HA fillers were longer-lasting than those achieved with bovine collagen.
The mean improvement in NLF score at 24 weeks after last treatment was still clinically significant (ie,. at least a 1-point improvement from baseline) in the HA-treated NLFs but not in the bovine collagen-treated NLFs.
The proportion of NLFs still showing a clinically significant improvement in NLF severity score at 24 weeks after last treatment was: 88% with 24HV, 90% with 30HV, and 36% to 40% with bovine collagen.
Safety
No serious treatment-related adverse events were reported with any of the fillers, and frequency and severity of treatment site reactions was similar for all the fillers. The majority of individual treatment site reactions lasted no more than 7 days, and there were no treatment-related adverse events other than those localized to the area of injection. For all treatment groups, the majority of treatment site reactions (e.g., erythema, induration, pain, edema, nodule, bruising, pruritus, and discoloration) were mild or moderate in severity and did not require intervention.
Conclusion
According to the authors, photographic documentation demonstrates that the new HA fillers are well-tolerated, result in a smooth and natural look to the skin post-injection and offer long-lasting NLF correction extending up to 11 months or more after last treatment. As a result, patients may not need repeat treatments as frequently as they might after bovine collagen treatment, and high levels of patient satisfaction would be anticipated.
Poster: Leslie Baumann, M.D., Jane A Thomas, A.A.S.,C.C.R.A., Diane K Murphy, M.B.A., Patricia Walker, M.D., Ph.D. Photographic Documentation Comparing Longterm Nasolabial fold Correction with New Hyaluronic Acid-based Fillers and Cross-linked Bovine Collagen: Results: from a Multicenter Double-Blind, Randomized, Study.
Data from Case Studies Suggesting Superficial Salicylic Acid Peels and Mequinol 2%/tretinoin 0.01% Topical Solution is Safe and Effective for Mild-to-Moderate PIH in Patients of Color
Method
The study population included three female patients, ages 22, 32, and 36, with Fitzpatrick skin types IV-V with mild-to-moderate facial postinflammatory hyperpigmentation (PIH) from acne as rated by the investigator at baseline. For 8 weeks, patients were to continue their regular skin care regimen and follow a sun avoidance/protection program.
Treatment/peel cycles were to include use of mequinol 2%/tretinoin 0.01% solution (applied twice daily, 8 hours apart), which would be discontinued for 3 days prior to the application of a 20% or 30% salicylic acid peel. Treatment with mequinoI 2%/tretinoin 0.01% solution would resume the day following the peel.
Peels would be applied approximately every 4 weeks, as tolerated.
Primary efficacy variables included Physician Global Assessment, Patient Global Assessment and Mexameter evaluation readings of each hyperpigmented target site (as compared to adjacent normal skin.
Conclusion
The case studies provide preliminary data suggesting that a dual modality regimen of superficial salicylic acid peels and mequinol 2%/tretinoin 0.01% topical solution is safe and effective for the treatment of mild-to-moderate PIH in patients with darker skin types.
Poster: Susan C. Taylor, M.D. Case Studies of Combination Treatment With a Solution of Mequinol 2%/Tretinoin 0.01% With Chemical Peels For Mild-To-Moderate Postinflammatory Hyperpigmentation.
Lipodissolve – Is It Safe?
By now, everyone has heard of Lipodissolve, a treatment touted as an alternative to liposuction to banish unwanted fat deposits from various parts of the body. Offered in clinics that have sprouted up throughout the country, this non-FDA-approved procedure involves a series of injections of a mixture of phosphatidylcholine and sodium deoxycholate (PC/DC) said to break down body fat.
The United Kingdom, Brazil and Canada, have banned the procedure, and the Kansas State Board of Healing Arts has been the first medical entity in the United States to do so. However, that decision was subsequently reversed.
Joel Schlessinger, M.D., President of the American Society of Cosmetic Dermatology & Aesthetic Surgery, is concerned.
“What we find with this procedure is that people are injecting a very irritating substance into the body — a combination of a soy product and cow bile — to dissolve the fat. The problem is that it’s become quite popular before any testing, studying or oversight of it by the FDA or any licensing body.”
Dr. Schlessinger says the procedure is being offered in what are called Lipodissolve clinics mainly by non-credentialed individuals who are not qualified to cope with serious complications. There is also a lack of information about how the product works and potential reactions. Dr. Schlessinger has heard of reactions in several patients, ranging from unexplained swelling for 2 years after the procedure to a general malaise that lasted months after a treatment.
“Sadly, this type of situation can be anticipated because this information has not yet been documented in such a new and unproven entity,” he says. “We don’t know how it works, what the process is and how the fat is brought out of the body.”
Dr. Schlessinger does add that the treatment may have merit. “There is some promise to this technology if it is proven safe. Let’s figure that out before people are harmed by something that’s not fully tested before it’s brought to market.”
Hyaluronic Acid-Based Fillers Offer Longer-Lasting Results in Nasolabial Folds Than Cross-Linked Bovine Collagen
Amulticenter, double-blind, randomized, within-subject controlled study used photo-documentation to compare results in nasolabial folds (NLF) treated with cross-linked bovine collagen with new hyaluronic acid-based (HA) fillers.
The study undertaken to document long-term — 8 to 11 months post-treatment — persistence of correction achievable with these fillers demonstrated that HA corrections were longer-lasting.
Methods
This multicenter, double-blind, randomized, within-subject controlled study included subjects with fully visible bilateral nasolabial folds (NLFs) that were moderate or severe (assessed at the deepest part) and were approximately symmetrical and of equal severity on each facial side.
Subjects were randomly assigned to NLF correction with one HA filler (24HV or 30HV) in one NLF and cross-linked bovine collagen filler in the other NLF.
Each study site had two investigators — both specialists in cosmetic dermatology or plastic surgery and experienced in the use of dermal fillers. While the treating investigator could not be masked, the evaluating investigator and the subjects were masked throughout the study.
Up to three treatments received over a 4-week period included initial treatment plus up to two touch-ups approximately 2 weeks apart to achieve optimal correction of the NLFs.
The evaluating investigator assessed the level of correction at 2 and 4 weeks after the initial treatment and, if less than optimal, the treating investigator re-treated the under-corrected NLF(s) with the same assigned filler(s).
Outcome Measures
Subjects were followed at least every 4 weeks for up to 24 weeks after the last treatment and may have had additional follow-up visit(s) if they returned after the end of the study, eg, for a complimentary repeat treatment.
At each visit the appearance of their NLFs was documented using standardized Canfield photography.
The evaluating investigator assessed NLF severity live using the 5-point Wrinkle Assessment Scale together with a validated photographic guide.
In addition, subjects reported their observations of common treatment site reactions on a daily basis from 30 minutes post-injection to day 13 after each treatment including touch-ups. Any additional adverse events reported by the subject or observed by the investigators were also recorded.
Results
Of 292 subjects randomly assigned to treatment with 24HV or 30HV, 280 (96%) completed the 24-week follow-up period. No subjects discontinued due to lack of effectiveness or adverse events.
All three of the fillers (24HV, 30HV, and bovine collagen) achieved statistically significant improvements in NLF severity score at every time point through the 24-week follow-up period. However, the improvements achieved with the HA fillers were longer-lasting than those achieved with bovine collagen.
The mean improvement in NLF score at 24 weeks after last treatment was still clinically significant (ie,. at least a 1-point improvement from baseline) in the HA-treated NLFs but not in the bovine collagen-treated NLFs.
The proportion of NLFs still showing a clinically significant improvement in NLF severity score at 24 weeks after last treatment was: 88% with 24HV, 90% with 30HV, and 36% to 40% with bovine collagen.
Safety
No serious treatment-related adverse events were reported with any of the fillers, and frequency and severity of treatment site reactions was similar for all the fillers. The majority of individual treatment site reactions lasted no more than 7 days, and there were no treatment-related adverse events other than those localized to the area of injection. For all treatment groups, the majority of treatment site reactions (e.g., erythema, induration, pain, edema, nodule, bruising, pruritus, and discoloration) were mild or moderate in severity and did not require intervention.
Conclusion
According to the authors, photographic documentation demonstrates that the new HA fillers are well-tolerated, result in a smooth and natural look to the skin post-injection and offer long-lasting NLF correction extending up to 11 months or more after last treatment. As a result, patients may not need repeat treatments as frequently as they might after bovine collagen treatment, and high levels of patient satisfaction would be anticipated.
Poster: Leslie Baumann, M.D., Jane A Thomas, A.A.S.,C.C.R.A., Diane K Murphy, M.B.A., Patricia Walker, M.D., Ph.D. Photographic Documentation Comparing Longterm Nasolabial fold Correction with New Hyaluronic Acid-based Fillers and Cross-linked Bovine Collagen: Results: from a Multicenter Double-Blind, Randomized, Study.
Data from Case Studies Suggesting Superficial Salicylic Acid Peels and Mequinol 2%/tretinoin 0.01% Topical Solution is Safe and Effective for Mild-to-Moderate PIH in Patients of Color
Method
The study population included three female patients, ages 22, 32, and 36, with Fitzpatrick skin types IV-V with mild-to-moderate facial postinflammatory hyperpigmentation (PIH) from acne as rated by the investigator at baseline. For 8 weeks, patients were to continue their regular skin care regimen and follow a sun avoidance/protection program.
Treatment/peel cycles were to include use of mequinol 2%/tretinoin 0.01% solution (applied twice daily, 8 hours apart), which would be discontinued for 3 days prior to the application of a 20% or 30% salicylic acid peel. Treatment with mequinoI 2%/tretinoin 0.01% solution would resume the day following the peel.
Peels would be applied approximately every 4 weeks, as tolerated.
Primary efficacy variables included Physician Global Assessment, Patient Global Assessment and Mexameter evaluation readings of each hyperpigmented target site (as compared to adjacent normal skin.
Conclusion
The case studies provide preliminary data suggesting that a dual modality regimen of superficial salicylic acid peels and mequinol 2%/tretinoin 0.01% topical solution is safe and effective for the treatment of mild-to-moderate PIH in patients with darker skin types.
Poster: Susan C. Taylor, M.D. Case Studies of Combination Treatment With a Solution of Mequinol 2%/Tretinoin 0.01% With Chemical Peels For Mild-To-Moderate Postinflammatory Hyperpigmentation.
Lipodissolve – Is It Safe?
By now, everyone has heard of Lipodissolve, a treatment touted as an alternative to liposuction to banish unwanted fat deposits from various parts of the body. Offered in clinics that have sprouted up throughout the country, this non-FDA-approved procedure involves a series of injections of a mixture of phosphatidylcholine and sodium deoxycholate (PC/DC) said to break down body fat.
The United Kingdom, Brazil and Canada, have banned the procedure, and the Kansas State Board of Healing Arts has been the first medical entity in the United States to do so. However, that decision was subsequently reversed.
Joel Schlessinger, M.D., President of the American Society of Cosmetic Dermatology & Aesthetic Surgery, is concerned.
“What we find with this procedure is that people are injecting a very irritating substance into the body — a combination of a soy product and cow bile — to dissolve the fat. The problem is that it’s become quite popular before any testing, studying or oversight of it by the FDA or any licensing body.”
Dr. Schlessinger says the procedure is being offered in what are called Lipodissolve clinics mainly by non-credentialed individuals who are not qualified to cope with serious complications. There is also a lack of information about how the product works and potential reactions. Dr. Schlessinger has heard of reactions in several patients, ranging from unexplained swelling for 2 years after the procedure to a general malaise that lasted months after a treatment.
“Sadly, this type of situation can be anticipated because this information has not yet been documented in such a new and unproven entity,” he says. “We don’t know how it works, what the process is and how the fat is brought out of the body.”
Dr. Schlessinger does add that the treatment may have merit. “There is some promise to this technology if it is proven safe. Let’s figure that out before people are harmed by something that’s not fully tested before it’s brought to market.”
Hyaluronic Acid-Based Fillers Offer Longer-Lasting Results in Nasolabial Folds Than Cross-Linked Bovine Collagen
Amulticenter, double-blind, randomized, within-subject controlled study used photo-documentation to compare results in nasolabial folds (NLF) treated with cross-linked bovine collagen with new hyaluronic acid-based (HA) fillers.
The study undertaken to document long-term — 8 to 11 months post-treatment — persistence of correction achievable with these fillers demonstrated that HA corrections were longer-lasting.
Methods
This multicenter, double-blind, randomized, within-subject controlled study included subjects with fully visible bilateral nasolabial folds (NLFs) that were moderate or severe (assessed at the deepest part) and were approximately symmetrical and of equal severity on each facial side.
Subjects were randomly assigned to NLF correction with one HA filler (24HV or 30HV) in one NLF and cross-linked bovine collagen filler in the other NLF.
Each study site had two investigators — both specialists in cosmetic dermatology or plastic surgery and experienced in the use of dermal fillers. While the treating investigator could not be masked, the evaluating investigator and the subjects were masked throughout the study.
Up to three treatments received over a 4-week period included initial treatment plus up to two touch-ups approximately 2 weeks apart to achieve optimal correction of the NLFs.
The evaluating investigator assessed the level of correction at 2 and 4 weeks after the initial treatment and, if less than optimal, the treating investigator re-treated the under-corrected NLF(s) with the same assigned filler(s).
Outcome Measures
Subjects were followed at least every 4 weeks for up to 24 weeks after the last treatment and may have had additional follow-up visit(s) if they returned after the end of the study, eg, for a complimentary repeat treatment.
At each visit the appearance of their NLFs was documented using standardized Canfield photography.
The evaluating investigator assessed NLF severity live using the 5-point Wrinkle Assessment Scale together with a validated photographic guide.
In addition, subjects reported their observations of common treatment site reactions on a daily basis from 30 minutes post-injection to day 13 after each treatment including touch-ups. Any additional adverse events reported by the subject or observed by the investigators were also recorded.
Results
Of 292 subjects randomly assigned to treatment with 24HV or 30HV, 280 (96%) completed the 24-week follow-up period. No subjects discontinued due to lack of effectiveness or adverse events.
All three of the fillers (24HV, 30HV, and bovine collagen) achieved statistically significant improvements in NLF severity score at every time point through the 24-week follow-up period. However, the improvements achieved with the HA fillers were longer-lasting than those achieved with bovine collagen.
The mean improvement in NLF score at 24 weeks after last treatment was still clinically significant (ie,. at least a 1-point improvement from baseline) in the HA-treated NLFs but not in the bovine collagen-treated NLFs.
The proportion of NLFs still showing a clinically significant improvement in NLF severity score at 24 weeks after last treatment was: 88% with 24HV, 90% with 30HV, and 36% to 40% with bovine collagen.
Safety
No serious treatment-related adverse events were reported with any of the fillers, and frequency and severity of treatment site reactions was similar for all the fillers. The majority of individual treatment site reactions lasted no more than 7 days, and there were no treatment-related adverse events other than those localized to the area of injection. For all treatment groups, the majority of treatment site reactions (e.g., erythema, induration, pain, edema, nodule, bruising, pruritus, and discoloration) were mild or moderate in severity and did not require intervention.
Conclusion
According to the authors, photographic documentation demonstrates that the new HA fillers are well-tolerated, result in a smooth and natural look to the skin post-injection and offer long-lasting NLF correction extending up to 11 months or more after last treatment. As a result, patients may not need repeat treatments as frequently as they might after bovine collagen treatment, and high levels of patient satisfaction would be anticipated.
Poster: Leslie Baumann, M.D., Jane A Thomas, A.A.S.,C.C.R.A., Diane K Murphy, M.B.A., Patricia Walker, M.D., Ph.D. Photographic Documentation Comparing Longterm Nasolabial fold Correction with New Hyaluronic Acid-based Fillers and Cross-linked Bovine Collagen: Results: from a Multicenter Double-Blind, Randomized, Study.
