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Tolerability and effect of facial subcutaneous injection of new dextran filler to the nasolabial folds: Multicenter, single blinded, single-arm, 24-week follow-up study
P6956
P6256
Open label study of 1% retinol and double-blind placebo-controlled study of 0.5% retinol both in an oil-free aqueous protein rich suspension Michael Gold, MD, Tennessee Clinical Research Center, Gold Skin Care Center, Nashville, TN, United States; Julie Biron, Tennessee Clinical Research Center, Nashville, TN, United States; Leon Kircik, MD, Physicians Skin Care, Louisville, KY, United States; Monika Kiripolsky, MD, Dermatologist Med Group of North County Inc, La Jolla, CA, United States; Vivian Bucay, MD, Private Practice, Vivian W. Bucay, San Antonio, TX, United States Photoaged skin is characterized by a variety of clinical, histologic, and biochemical features. Topically applied retinol penetrates the skin and a small amount is converted to all-trans retinoic acid (tretinoin)which improves the appearance of photoaging. Retinol irritates skin less than retinoic acid at similar concentrations, and therefore appears to deliver the clinical benefits of retinoic acid with higher tolerability. A novel high protein, oil-free aqueous delivery system promotes penetration of retinol. Two studies examined efficacy and tolerability. In the first, subjects at 2 sites (n ¼ 6; n ¼ 5) with photodamaged skin applied the novel suspension of retinol (1%) daily to their faces for 8 to 12 weeks. Improvements in UV-induced features were graded at 4 to 6 weeks and at 8 to 12 weeks using appropriate 4- or 5-point scales. At 8 to 12 weeks, the percentage of subjects showing improvement of at least 1 grade was 100% for overall photodamage, crow’s feet, and lack of elasticity; 90% for cheek wrinkles and lack of brightness; 80% for mottled hyperpigmentation; 70% for under-eye wrinkles and forehead wrinkles; and 40% for skin roughness. Some irritation was noted but not documented. For all characteristics except under-eye wrinkles, percentage of improved patients was higher at 8 to 12 weeks than at 4 to 6 weeks, suggesting that improvement occurs rapidly, increases, and may continue beyond 8 to 12 weeks. The results warranted study at lower product concentrations.At a third site females (n ¼ 30) with facial photodamage applied the same vehicle with or without retinol (0.5%) daily for 8 weeks. According to a randomized, double-blind protocol; subjects applied either the test product (n ¼ 22) or vehicle only (n ¼ 8). Improvements in photodamage were graded at 4 and 8 weeks. By week 8 improvements were modest, most likely because of the lower retinol concentration, but incidence of burning, pruritus, dryness, and erythema were minimal and statistically irrelevant. Longer-term study to determine whether or not topically applied 0.5% retinolcan provide benefits comparable to those seen with topically applied 1% retinol when applied over a longer time period would be beneficial.
Reduction of double chin caused by submental fat with ATX-101: Results from the ATX-101-10-17 European phase III study Benjamin Ascher, MD, PhD, Clinic of Aesthetic Surgery IENA, Paris, France; Blanka Havlickova, MD, PhD, Bayer HealthCare, Dermatology, Global Clinical Development, Berlin, Germany; Klaus Hoffmann, MD, PhD, Ruhr University Bochum, Bochum, Germany; Patricia Walker, MD, PhD, Kythera Biopharmaceuticals, Inc, Calabasas, CA, United States Background: ATX-101, a proprietary formulation of synthetically derived sodium deoxycholate (sodium salt of deoxycholic acid), is an investigational injectable drug for the reduction of double chin caused by submental fat, localized fat below the chin. Currently, there are no approved pharmacologic therapies for the reduction of double chin. Methods: In this second of 2 pivotal phase III, multicenter, double-blind, placebocontrolled studies, 360 subjects with submental fat rated as moderate or severe were randomly assigned (1:1:1) to receive injections of ATX-101 dosed at 1 mg/cm2 or 2 mg/cm2, or placebo (vehicle). Subjects received up to 4 treatment sessions, spaced at least 28 days apart, and were followed until 12 weeks after their last treatment. Clinicians evaluated submental fat using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS). Subjects evaluated the amount of their submental fat using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS), the satisfaction with their appearance associated with the face and chin using the Subject Self-Rating Scale (SSRS), and the psychological and visual impact of their submental fat using the Patient-Reported Submental Fat Impact Scale (PR-SMFIS). Satisfaction with treatment was measured using the Global Post-Treatment Satisfaction Scale. Results: At 12 weeks after last treatment, both 1 mg/cm2 and 2 mg/cm2 ATX-101 groups showed a statistically significant greater improvement (P \.001) compared to placebo in mean scores for CR-SMFRS (0.7 and 0.7, respectively, vs 0.3 with placebo), PR-SMFRS (0.9 and 0.9 vs 0.4), and SSRS (2.7 and 2.6 vs 1.4). Both ATX-101 groups also showed a greater reduction in psychological and visual impact (P \.01) and greater satisfaction with treatment (P \ .01). The incidence of treatment satisfaction was 86% and 85% versus 58%. Adverse events (AEs) were mostly mild to moderate in severity and transient. The most common treatment-related AEs were pain, swelling, numbness, bruising, and redness, and these were limited to the injection site.
100% sponsored by Biopelle.
Conclusion: ATX-101 treatment was associated with a reduction in submental fat and in its psychological and visual impact, and an improvement in subject satisfaction with appearance and with treatment. These changes were statistically significant compared to placebo. These results confirm those from the first European phase III study and offer evidence that ATX-101 may offer a new pharmacologic option for reduction of double chin. Supported by Kythera Biopharmaceuticals, Inc.
P6810 P7060 Photodynamic therapy with methylaminolevulinate (MAL) for the treatment of photoaging Juliana Caramel, MD, Fundac¸~ao Pele Saudavel, S~ao Paulo, Brazil; Carla Bortoloto, MPA, Fundac¸~ao Pele Saudavel, S~ao Paulo, Brazil; Rafael Pessanha, MD, Fundac¸~ao Pele Saudavel, S~ao Paulo, Brazil; Ricardo Villa, MD, Findac¸~ao Pele Saudavel, S~ao Paulo, Brazil; Valcinir Bedin, MD, Fundac¸~ao Pele Saudavel, S~ao Paulo, Brazil Background: Photodynamic therapy (PDT) has been shown to be effective in the treatment and prevention of nonmelanoma skin cancer. Most common uses include the treatment of actinic keratosis (AK), basal cell carcinoma (BCC), squamous cell carcinoma (SCC), Bowen disease. and acne vulgaris. The aesthetic effects of PDT on photodamaged skin are not well documented. Methods: Thirty patients (5 men and 25 women) with facial photoaging underwent a single session of PDT. Metvix was applied under occlusion for 3 hours before exposure to 37 J/cm2 of red light (Aklilite). The evaluation was made through the preauricular skin biopsies before and 90 days after the procedure, photographic analysis by 3 independent dermatologists in pre- and postprocedure and a quality of life questionnaire answered by the patients.The answers to the evaluations were tabulated, categorized, and allowed patient satisfaction analysis. Results: There was a significant improvement in hyperpigmentation, fine lines, roughness, and pale skin. The 30 patients (100%) felt that the fine wrinkles and skin blemishes were softened, 25 patients (83%) considered that the overall quality of skin improved after treatment, and 27 patients (90%) reported satisfaction with the results obtained (P \ .001), 6 patients (20%) referred improvement in their professional lives; 18 patients (60%), improvement in their social lives; 6 patients (20%), of their affective lives; and 3 (10%) of their sexual lives. Deep wrinkles, erythema, facial teleangiectasia and hypertrophy of the sebaceous glands showed a less significant improvement. Histologic analysis revealed a reduction of signs of photoaging in the reduction of elastotic material and a dramatic increase of new collagen and elastin fibers.
Tolerability and effect of facial subcutaneous injection of new dextran filler to the nasolabial folds: Multicenter, single blinded, single-arm, 24week follow-up study Sang Seok Kim, MD, Kangdong Sacred Heart Hospital, Hallym University, Seoul, South Korea; Chul Woo Kim, MD, Kangdong Sacred Heart Hospital, Seoul, South Korea; Min Seong Kil, MD, Kangdong Sacred Heart Hospital, Seoul, South Korea; Soo Jung Shin, MD, Kangdong Sacred Herat Hospital, Seoul, South Korea; Young Her, MD, Chuncheon Sacred Herat Hospital, Chuncheon, South Korea
Conclusion: Noninvasive procedures for facial rejuvenation are becoming increasingly popular among the treatments options and skin care. Photodynamic therapy (PDT) is been used to improve the signs of photodamage with less downtime. In this study, a dramatic increase of new collagen and elastin fibers was clearly visible in all patients. Whenever a patient needs treatment for both conditions malignant and photoaging, PDT will take its place.
Dextran filler is a relatively newly introduced agent, and its use is growing in the filler market. The prolonged efficacy of dextran filler is attributed to cross-linking between dextran polymers and to gradual absorption of water as the filler degrades. Some data suggest that dextran filler has abundant neocollagenesis properties, so it stimulates collagen synthesis and inhibits collagen breakdown, which may contribute to its effectiveness and long duration of its action. The efficacy, safety, and participant satisfaction after nasolabial folds augmentation with new dextran filler were assessed for 24 weeks in the randomized, evaluator-blinded study. Newly developed cross-linked dextran filler was used in this study. Twenty participants with moderate to severe nasolabial folds wrinkles were enrolled from the 2 university hospitals. Only 1 injection was performed initially on both sides of nasolabial folds, and the assessment was done 5 times at 4 to 12 intervals for 24 weeks by practitioner and other 3 dermatologists who did not participate in the procedure. Objective improvement using the 5-grade Wrinkle Severity Rating Scale scores (WSRS) of nasolabial folds, subjective satisfaction by participants and undesirable side effects were recorded at each visit. First validity evaluation was performed by the 2 independent evaluators. When they scored a different WSRS for the same photos of the patients, sequentially a second validity evaluation was done by the third evaluator. At week 24, 90% of participants remained improved significantly from baseline, with mean improvements ranging from 1 to 3 grades of WSRS. Mean WSRS was 3.75 6 0.64 before injection and 2.25 6 0.64 at week 24, each. Seventeen out of 20 participants (85%) responded satisfactorily. First and second validity evaluations also showed a statistically significant difference between pre- and posttreatment state (P\.0001). Mean volume of filler injected into 1 side of lasolabial fold was 2.39 6 0.64 mL. There was only 1 case of bacterial infection at week 4. According to our study, new cross-linked dextran filler showed considerable improvement of nasolabial folds with rare nonserious adverse effects. In addition, it can be injected easily using small-gauge needles with mild local injection site reactions and minimal pain. New cross-linked dextran filler will be one of the key components to the successful treatment of the aging face.
100% is sponsered by Galderma.
50% is sponsored by Chunghwa Medipower.
APRIL 2013
J AM ACAD DERMATOL
AB25
P6256
Open label study of 1% retinol and double-blind placebo-controlled study of 0.5% retinol both in an oil-free aqueous protein rich suspension Michael Gold, MD, Tennessee Clinical Research Center, Gold Skin Care Center, Nashville, TN, United States; Julie Biron, Tennessee Clinical Research Center, Nashville, TN, United States; Leon Kircik, MD, Physicians Skin Care, Louisville, KY, United States; Monika Kiripolsky, MD, Dermatologist Med Group of North County Inc, La Jolla, CA, United States; Vivian Bucay, MD, Private Practice, Vivian W. Bucay, San Antonio, TX, United States Photoaged skin is characterized by a variety of clinical, histologic, and biochemical features. Topically applied retinol penetrates the skin and a small amount is converted to all-trans retinoic acid (tretinoin)which improves the appearance of photoaging. Retinol irritates skin less than retinoic acid at similar concentrations, and therefore appears to deliver the clinical benefits of retinoic acid with higher tolerability. A novel high protein, oil-free aqueous delivery system promotes penetration of retinol. Two studies examined efficacy and tolerability. In the first, subjects at 2 sites (n ¼ 6; n ¼ 5) with photodamaged skin applied the novel suspension of retinol (1%) daily to their faces for 8 to 12 weeks. Improvements in UV-induced features were graded at 4 to 6 weeks and at 8 to 12 weeks using appropriate 4- or 5-point scales. At 8 to 12 weeks, the percentage of subjects showing improvement of at least 1 grade was 100% for overall photodamage, crow’s feet, and lack of elasticity; 90% for cheek wrinkles and lack of brightness; 80% for mottled hyperpigmentation; 70% for under-eye wrinkles and forehead wrinkles; and 40% for skin roughness. Some irritation was noted but not documented. For all characteristics except under-eye wrinkles, percentage of improved patients was higher at 8 to 12 weeks than at 4 to 6 weeks, suggesting that improvement occurs rapidly, increases, and may continue beyond 8 to 12 weeks. The results warranted study at lower product concentrations.At a third site females (n ¼ 30) with facial photodamage applied the same vehicle with or without retinol (0.5%) daily for 8 weeks. According to a randomized, double-blind protocol; subjects applied either the test product (n ¼ 22) or vehicle only (n ¼ 8). Improvements in photodamage were graded at 4 and 8 weeks. By week 8 improvements were modest, most likely because of the lower retinol concentration, but incidence of burning, pruritus, dryness, and erythema were minimal and statistically irrelevant. Longer-term study to determine whether or not topically applied 0.5% retinolcan provide benefits comparable to those seen with topically applied 1% retinol when applied over a longer time period would be beneficial.
Reduction of double chin caused by submental fat with ATX-101: Results from the ATX-101-10-17 European phase III study Benjamin Ascher, MD, PhD, Clinic of Aesthetic Surgery IENA, Paris, France; Blanka Havlickova, MD, PhD, Bayer HealthCare, Dermatology, Global Clinical Development, Berlin, Germany; Klaus Hoffmann, MD, PhD, Ruhr University Bochum, Bochum, Germany; Patricia Walker, MD, PhD, Kythera Biopharmaceuticals, Inc, Calabasas, CA, United States Background: ATX-101, a proprietary formulation of synthetically derived sodium deoxycholate (sodium salt of deoxycholic acid), is an investigational injectable drug for the reduction of double chin caused by submental fat, localized fat below the chin. Currently, there are no approved pharmacologic therapies for the reduction of double chin. Methods: In this second of 2 pivotal phase III, multicenter, double-blind, placebocontrolled studies, 360 subjects with submental fat rated as moderate or severe were randomly assigned (1:1:1) to receive injections of ATX-101 dosed at 1 mg/cm2 or 2 mg/cm2, or placebo (vehicle). Subjects received up to 4 treatment sessions, spaced at least 28 days apart, and were followed until 12 weeks after their last treatment. Clinicians evaluated submental fat using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS). Subjects evaluated the amount of their submental fat using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS), the satisfaction with their appearance associated with the face and chin using the Subject Self-Rating Scale (SSRS), and the psychological and visual impact of their submental fat using the Patient-Reported Submental Fat Impact Scale (PR-SMFIS). Satisfaction with treatment was measured using the Global Post-Treatment Satisfaction Scale. Results: At 12 weeks after last treatment, both 1 mg/cm2 and 2 mg/cm2 ATX-101 groups showed a statistically significant greater improvement (P \.001) compared to placebo in mean scores for CR-SMFRS (0.7 and 0.7, respectively, vs 0.3 with placebo), PR-SMFRS (0.9 and 0.9 vs 0.4), and SSRS (2.7 and 2.6 vs 1.4). Both ATX-101 groups also showed a greater reduction in psychological and visual impact (P \.01) and greater satisfaction with treatment (P \ .01). The incidence of treatment satisfaction was 86% and 85% versus 58%. Adverse events (AEs) were mostly mild to moderate in severity and transient. The most common treatment-related AEs were pain, swelling, numbness, bruising, and redness, and these were limited to the injection site.
100% sponsored by Biopelle.
Conclusion: ATX-101 treatment was associated with a reduction in submental fat and in its psychological and visual impact, and an improvement in subject satisfaction with appearance and with treatment. These changes were statistically significant compared to placebo. These results confirm those from the first European phase III study and offer evidence that ATX-101 may offer a new pharmacologic option for reduction of double chin. Supported by Kythera Biopharmaceuticals, Inc.
P6810 P7060 Photodynamic therapy with methylaminolevulinate (MAL) for the treatment of photoaging Juliana Caramel, MD, Fundac¸~ao Pele Saudavel, S~ao Paulo, Brazil; Carla Bortoloto, MPA, Fundac¸~ao Pele Saudavel, S~ao Paulo, Brazil; Rafael Pessanha, MD, Fundac¸~ao Pele Saudavel, S~ao Paulo, Brazil; Ricardo Villa, MD, Findac¸~ao Pele Saudavel, S~ao Paulo, Brazil; Valcinir Bedin, MD, Fundac¸~ao Pele Saudavel, S~ao Paulo, Brazil Background: Photodynamic therapy (PDT) has been shown to be effective in the treatment and prevention of nonmelanoma skin cancer. Most common uses include the treatment of actinic keratosis (AK), basal cell carcinoma (BCC), squamous cell carcinoma (SCC), Bowen disease. and acne vulgaris. The aesthetic effects of PDT on photodamaged skin are not well documented. Methods: Thirty patients (5 men and 25 women) with facial photoaging underwent a single session of PDT. Metvix was applied under occlusion for 3 hours before exposure to 37 J/cm2 of red light (Aklilite). The evaluation was made through the preauricular skin biopsies before and 90 days after the procedure, photographic analysis by 3 independent dermatologists in pre- and postprocedure and a quality of life questionnaire answered by the patients.The answers to the evaluations were tabulated, categorized, and allowed patient satisfaction analysis. Results: There was a significant improvement in hyperpigmentation, fine lines, roughness, and pale skin. The 30 patients (100%) felt that the fine wrinkles and skin blemishes were softened, 25 patients (83%) considered that the overall quality of skin improved after treatment, and 27 patients (90%) reported satisfaction with the results obtained (P \ .001), 6 patients (20%) referred improvement in their professional lives; 18 patients (60%), improvement in their social lives; 6 patients (20%), of their affective lives; and 3 (10%) of their sexual lives. Deep wrinkles, erythema, facial teleangiectasia and hypertrophy of the sebaceous glands showed a less significant improvement. Histologic analysis revealed a reduction of signs of photoaging in the reduction of elastotic material and a dramatic increase of new collagen and elastin fibers.
Tolerability and effect of facial subcutaneous injection of new dextran filler to the nasolabial folds: Multicenter, single blinded, single-arm, 24week follow-up study Sang Seok Kim, MD, Kangdong Sacred Heart Hospital, Hallym University, Seoul, South Korea; Chul Woo Kim, MD, Kangdong Sacred Heart Hospital, Seoul, South Korea; Min Seong Kil, MD, Kangdong Sacred Heart Hospital, Seoul, South Korea; Soo Jung Shin, MD, Kangdong Sacred Herat Hospital, Seoul, South Korea; Young Her, MD, Chuncheon Sacred Herat Hospital, Chuncheon, South Korea
Conclusion: Noninvasive procedures for facial rejuvenation are becoming increasingly popular among the treatments options and skin care. Photodynamic therapy (PDT) is been used to improve the signs of photodamage with less downtime. In this study, a dramatic increase of new collagen and elastin fibers was clearly visible in all patients. Whenever a patient needs treatment for both conditions malignant and photoaging, PDT will take its place.
Dextran filler is a relatively newly introduced agent, and its use is growing in the filler market. The prolonged efficacy of dextran filler is attributed to cross-linking between dextran polymers and to gradual absorption of water as the filler degrades. Some data suggest that dextran filler has abundant neocollagenesis properties, so it stimulates collagen synthesis and inhibits collagen breakdown, which may contribute to its effectiveness and long duration of its action. The efficacy, safety, and participant satisfaction after nasolabial folds augmentation with new dextran filler were assessed for 24 weeks in the randomized, evaluator-blinded study. Newly developed cross-linked dextran filler was used in this study. Twenty participants with moderate to severe nasolabial folds wrinkles were enrolled from the 2 university hospitals. Only 1 injection was performed initially on both sides of nasolabial folds, and the assessment was done 5 times at 4 to 12 intervals for 24 weeks by practitioner and other 3 dermatologists who did not participate in the procedure. Objective improvement using the 5-grade Wrinkle Severity Rating Scale scores (WSRS) of nasolabial folds, subjective satisfaction by participants and undesirable side effects were recorded at each visit. First validity evaluation was performed by the 2 independent evaluators. When they scored a different WSRS for the same photos of the patients, sequentially a second validity evaluation was done by the third evaluator. At week 24, 90% of participants remained improved significantly from baseline, with mean improvements ranging from 1 to 3 grades of WSRS. Mean WSRS was 3.75 6 0.64 before injection and 2.25 6 0.64 at week 24, each. Seventeen out of 20 participants (85%) responded satisfactorily. First and second validity evaluations also showed a statistically significant difference between pre- and posttreatment state (P\.0001). Mean volume of filler injected into 1 side of lasolabial fold was 2.39 6 0.64 mL. There was only 1 case of bacterial infection at week 4. According to our study, new cross-linked dextran filler showed considerable improvement of nasolabial folds with rare nonserious adverse effects. In addition, it can be injected easily using small-gauge needles with mild local injection site reactions and minimal pain. New cross-linked dextran filler will be one of the key components to the successful treatment of the aging face.
100% is sponsered by Galderma.
50% is sponsored by Chunghwa Medipower.
APRIL 2013
J AM ACAD DERMATOL
AB25