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Fixed-dose adapalene-benzoyl peroxide gel is synergistically efficacious in the treatment of acne vulgaris: A metaanalysis of studies in 3855 patients
P716
P718
Studies of the dermal tolerability of a prescription benzoyl peroxide 5.3% topical emollient foam Hilary Baldwin, MD, Department of Dermatology SUNY Downstate Medical Center, Brooklyn, NY, United States; Mark Trumbore, PhD, Onset Therapeutics, Cumberland, RI, United States
Fixed-dose adapalene-benzoyl peroxide gel is synergistically efficacious in the treatment of acne vulgaris: A metaanalysis of studies in 3855 patients Jerry Tan, MD, Windsor Clinical Research, Windsor, Ontario, Canada; Christian Loesche, MD, Galderma R&D, Sophia Antipolis, France; Harald P.M. Gollnick, MD, Otto von Guericke Universit€at Magdeburg, Magdeburg, Germany; Linda Stein Gold, MD, Henry Ford Health System, West Bloomfield, MI, United States; Y. May Ms, PhD, Galderma R&D, Sophia Antipolis, France Background: To compare the efficacy and safety of a fixed-dose adapalene 0.1%benzoyl peroxide (BPO) 2.5% combination gel to those of monotherapies and vehicle, in treatment of acne vulgaris. Methods: A metaanalysis of three multicenter, randomized, double-blind, parallel group studies was conducted. Adapalene-BPO, adapalene, BPO, or vehicle was applied once daily for 12 weeks. Efficacy criteria included success rate (% of patients with Investigator Global Assessment [IGA] rated ‘‘clear’’ or ‘‘almost clear’’) and percent change in lesion counts (inflammatory lesion [IL], noninflammatory lesion [NIL], and total lesion). Safety evaluations included assessments of local tolerability signs and adverse events.
Benzoyl peroxide is an antimicrobial agent that has been proven effective in the treatment of both inflammatory and comedonal acne. However, its use has been associated with adverse reactions such as erythema, skin dryness, scaling, and itching. The tolerability of a 5.3% benzoyl peroxide emollient foam has been studied in a 48-person case study series and two 10-person clinical laboratory studies. The studies were performed to examine the tolerability and drying potential of the benzoyl peroxide topical emollient foam and to determine if any tolerability and hydrating benefits seen in the laboratory would translate into clinical practice. In the first laboratory study, the change in erythema following benzoyl peroxide topical emollient foam use was monitored. The results of this study indicated that the benzoyl peroxide topical emollient foam was well tolerated and elicited no significant difference in erythema from vehicle at all time points measured. The second laboratory study examined the drying potential of benzoyl peroxide topical products and demonstrated that in contrast to gel formulations, the benzoyl peroxide topical emollient foam elicited a statistically significant increase in the average skin hydration 1 to 8 hours posttreatment. To validate the laboratory findings, a 48-person open-label case study series was conducted to examine the clinical tolerability of the 5.3% benzoyl peroxide foam. In the study, patients were treated for between 3 and 9 weeks. Patients were treated with the 5.3% foam either alone or in combination with other acne treatments with drug applied to the face, chest and back. Investigators graded five signs and symptoms of skin irritation (erythema, dryness, peeling, stinging, and itching) at baseline and at completion of treatment using a scale of 0 to 3. These scores were summed together for an overall skin irritation score. The results of the case study series demonstrated a greater than 10% reduction in skin irritation score from baseline after 4 and 8 weeks of use of the 5.3% benzoyl peroxide foam treatment. In laboratory studies, the novel benzoyl peroxide 5.3% emollient foam has demonstrated a lack of irritation potential as well as the ability to moisturize skin. In clinical practice, these benefits translated into a low incidence of adverse reactions, such as skin dryness, local irritation, and redness that have been commonly associated with the use of acne treatments containing benzoyl peroxide.
Results: Data of 3855 patients from three clinical studies with a similar study design were pooled and analyzed. At endpoint, success rate of adapalene-BPO (33.1%) was significantly greater (P \.001) than that of adapalene (20.0%), BPO (23.1%), and vehicle (14.2%). The net effect (active minus vehicle) of adpalene-BPO (18.9%) was greater than the sum of net effect of adapalene alone plus BPO alone (5.8% plus 8.9%; ie, 14.7%), indicating a synergistic effect of the two components in the fixeddose combination gel. Adapalene-BPO was also significantly more efficacious than the monotherapies and vehicle in decreasing IL, NIL, and total lesion counts at all time points (P \.05). Overall, slightly more patients in the adapalene-BPO group experienced local tolerability signs compared to the other arms. However, these were transient and mostly mild or moderate in severity. Conclusion: The unique and once daily fixed-dose adapalene-BPO combination gel provides significantly greater and synergistic efficacy with a good tolerability profile in the treatment of acne vulgaris when compared to the corresponding monotherapies. Commercial support: Study and poster support provided by Galderma Laboratories, L.P.
Commercial support: 100% sponsored by Onset Therapeutics.
P719
P717 Adapalene lotion 0.1% shows comparable tolerability to adapalene cream 0.1% in a split-face comparison Thomas J. Stephens, PhD, Stephens & Associates, Carrollton, TX, United States; Luz E. Colon, MS, Galderma Laboratories, L.P., Fort Worth, TX, United States; Nathan S. Trookman, MD, Stephens & Associates, Colorado Springs, CO, United States; Ronald L. Rizer, PhD, Stephens & Associates, Colorado Springs, CO, United States; Ronald W. Gottschalk, MD, Galderma Laboratories, L.P., Fort Worth, TX, United States Effective treatment for acne vulgaris relies on patient compliance for optimal results. Treatment tolerability is central to encouraging patient compliance. Adapalene cream 0.1% is a topical treatment for acne vulgaris that has excellent tolerability and is associated with a low incidence of cutaneous adverse events. Adapalene lotion 0.1% is a new formulation indicated for the topical treatment for acne vulgaris that also had a low incidence of cutaneous irritation in pivotal trials. Two single-center, randomized, evaluator-blinded, split-face comparison studies were conducted to evaluate the tolerability and safety of adapalene lotion 0.1% versus adapalene cream 0.1%. A total of 144 volunteers were enrolled (site 1 ¼ 75 volunteers with a mean age of 42 years, site 2 ¼ 69 volunteers with a mean age of 37 years) across Fitzpatrick skin types I to VI. Healthy volunteers aged $ 18 years applied adapalene cream 0.1% to the right or left side of the face (in a randomized fashion) and applied adapalene lotion 0.1% to the opposite side of the face once daily for 3 consecutive weeks (21 days). Volunteers were asked to complete a cosmetic acceptability questionnaire regarding preference and product aesthetics at the end of treatment. The worst postbaseline local tolerability scores for each parameter (regardless of time point) were evaluated and compared between the two groups. There were no statistically significant differences between adapalene lotion 0.1% and adapalene cream 0.1% in cutaneous irritation. Nine patients experienced 17 AEs that were related to one of the study medications. AEs related to treatment included scaling, dryness, erythema, itching, burning/stinging, and bumps on chin and were experienced for both adapalene lotion and adapalene cream. Lastly, there were no statistically significant differences between the two treatments in subject satisfaction. In conclusion, the results from this study show that tolerability and cosmetic acceptability for adapalene lotion, 0.1% and adapalene cream, 0.1% are similar. Commercial support: Study and poster support provided by Galderma Laboratories, L.P.
FEBRUARY 2011
The use of autologous platelet gel enhances the efficacy of skin needling for the treatment of acne scarring Gabriella Fabbrocini, PhD, University of Naples ‘‘Federico II,’’ Department of Systematic Pathology, Division of Dermatology, Naples, Italy; Antonella Tosti, PhD, Department of Internal Medicine, Geriatrics and Nephrology, Division of Dermatology, University of Bologna, Bologna, Italy; Elio D’Agostino, PhD, University of Naples ‘‘Federico II,’’ Department of Molecular and Cellular Biology and Pathology, Naples, Italy; Luigia Panariello, MD, University of Naples ‘‘Federico II,’’ Department of Sistematic Pathology, Division of Dermatology, Naples, Italy; Rossana Sepulveres, PhD, University of Naples ‘‘Federico II,’’ Department of Molecular and Cellular Biology and Pathology, Naples, Italy Introduction: Acne scarring is difficult to approach for a simple and definitive solution. At present, there are different methods available to treat acne scars. A combination of several treatment procedures could be appropriate, depending on specific patient features. Skin needling is a relatively new technique that is simple and effective for treating acne scars. Autologous platelet gel is created from autologous blood, which is centrifuged to produce a concentrate high in both plasma and platelets that releases the bioactive proteins and growth factors necessary to initiate and accelerate tissue repair and regeneration, improving wound healing. The aim of this study was to show that autologous platelet gel enhances the efficacy of skin needling for the treatment of acne scarring. Methods: Fifteen patients (8 female, 7 males; age range, 18-45 years) with acne rolling scars were included. Each patient underwent two session of treatments, each consisting of skin needling followed by APG application on one side of the face and only skin needling to the other half of face. Using digital cameras, photographs of all patients were taken to evaluate scar depth.The photographic data were analyzed by using the sign test (a \ .05). Results: Analysis of the patient photographs, supported by the sign test showed that after only two sessions, the severity grade of rolling scars in all patients was greatly reduced and there was an overall aesthetic improvement. Conclusion: Skin needling is an appropriate method to treat acne scars. It induces a wound healing response developing in three phases (inflammation, proliferation, and remodeling). During the proliferation phase, several growth factors, including platelet-derived growth factor, fibroblast growth factor, and transforming growth factors alfa and beta are released. Furthermore, this procedure provides a channel for autologous platelet gel to be absorbed more effectively through the top layer of skin. This gel contains autologous growth factors that could act synergistically with growth factors induced by skin needling in order to enhance the wound healing response. The present study shows that the application of an autologous platelet gel enhanced the efficacy of skin needling producing an overall aesthetic improvement, but the improvement was more efficient on the side of the face treated with skin needling and APG application. Commercial support: None identified.
J AM ACAD DERMATOL
AB17
P718
Studies of the dermal tolerability of a prescription benzoyl peroxide 5.3% topical emollient foam Hilary Baldwin, MD, Department of Dermatology SUNY Downstate Medical Center, Brooklyn, NY, United States; Mark Trumbore, PhD, Onset Therapeutics, Cumberland, RI, United States
Fixed-dose adapalene-benzoyl peroxide gel is synergistically efficacious in the treatment of acne vulgaris: A metaanalysis of studies in 3855 patients Jerry Tan, MD, Windsor Clinical Research, Windsor, Ontario, Canada; Christian Loesche, MD, Galderma R&D, Sophia Antipolis, France; Harald P.M. Gollnick, MD, Otto von Guericke Universit€at Magdeburg, Magdeburg, Germany; Linda Stein Gold, MD, Henry Ford Health System, West Bloomfield, MI, United States; Y. May Ms, PhD, Galderma R&D, Sophia Antipolis, France Background: To compare the efficacy and safety of a fixed-dose adapalene 0.1%benzoyl peroxide (BPO) 2.5% combination gel to those of monotherapies and vehicle, in treatment of acne vulgaris. Methods: A metaanalysis of three multicenter, randomized, double-blind, parallel group studies was conducted. Adapalene-BPO, adapalene, BPO, or vehicle was applied once daily for 12 weeks. Efficacy criteria included success rate (% of patients with Investigator Global Assessment [IGA] rated ‘‘clear’’ or ‘‘almost clear’’) and percent change in lesion counts (inflammatory lesion [IL], noninflammatory lesion [NIL], and total lesion). Safety evaluations included assessments of local tolerability signs and adverse events.
Benzoyl peroxide is an antimicrobial agent that has been proven effective in the treatment of both inflammatory and comedonal acne. However, its use has been associated with adverse reactions such as erythema, skin dryness, scaling, and itching. The tolerability of a 5.3% benzoyl peroxide emollient foam has been studied in a 48-person case study series and two 10-person clinical laboratory studies. The studies were performed to examine the tolerability and drying potential of the benzoyl peroxide topical emollient foam and to determine if any tolerability and hydrating benefits seen in the laboratory would translate into clinical practice. In the first laboratory study, the change in erythema following benzoyl peroxide topical emollient foam use was monitored. The results of this study indicated that the benzoyl peroxide topical emollient foam was well tolerated and elicited no significant difference in erythema from vehicle at all time points measured. The second laboratory study examined the drying potential of benzoyl peroxide topical products and demonstrated that in contrast to gel formulations, the benzoyl peroxide topical emollient foam elicited a statistically significant increase in the average skin hydration 1 to 8 hours posttreatment. To validate the laboratory findings, a 48-person open-label case study series was conducted to examine the clinical tolerability of the 5.3% benzoyl peroxide foam. In the study, patients were treated for between 3 and 9 weeks. Patients were treated with the 5.3% foam either alone or in combination with other acne treatments with drug applied to the face, chest and back. Investigators graded five signs and symptoms of skin irritation (erythema, dryness, peeling, stinging, and itching) at baseline and at completion of treatment using a scale of 0 to 3. These scores were summed together for an overall skin irritation score. The results of the case study series demonstrated a greater than 10% reduction in skin irritation score from baseline after 4 and 8 weeks of use of the 5.3% benzoyl peroxide foam treatment. In laboratory studies, the novel benzoyl peroxide 5.3% emollient foam has demonstrated a lack of irritation potential as well as the ability to moisturize skin. In clinical practice, these benefits translated into a low incidence of adverse reactions, such as skin dryness, local irritation, and redness that have been commonly associated with the use of acne treatments containing benzoyl peroxide.
Results: Data of 3855 patients from three clinical studies with a similar study design were pooled and analyzed. At endpoint, success rate of adapalene-BPO (33.1%) was significantly greater (P \.001) than that of adapalene (20.0%), BPO (23.1%), and vehicle (14.2%). The net effect (active minus vehicle) of adpalene-BPO (18.9%) was greater than the sum of net effect of adapalene alone plus BPO alone (5.8% plus 8.9%; ie, 14.7%), indicating a synergistic effect of the two components in the fixeddose combination gel. Adapalene-BPO was also significantly more efficacious than the monotherapies and vehicle in decreasing IL, NIL, and total lesion counts at all time points (P \.05). Overall, slightly more patients in the adapalene-BPO group experienced local tolerability signs compared to the other arms. However, these were transient and mostly mild or moderate in severity. Conclusion: The unique and once daily fixed-dose adapalene-BPO combination gel provides significantly greater and synergistic efficacy with a good tolerability profile in the treatment of acne vulgaris when compared to the corresponding monotherapies. Commercial support: Study and poster support provided by Galderma Laboratories, L.P.
Commercial support: 100% sponsored by Onset Therapeutics.
P719
P717 Adapalene lotion 0.1% shows comparable tolerability to adapalene cream 0.1% in a split-face comparison Thomas J. Stephens, PhD, Stephens & Associates, Carrollton, TX, United States; Luz E. Colon, MS, Galderma Laboratories, L.P., Fort Worth, TX, United States; Nathan S. Trookman, MD, Stephens & Associates, Colorado Springs, CO, United States; Ronald L. Rizer, PhD, Stephens & Associates, Colorado Springs, CO, United States; Ronald W. Gottschalk, MD, Galderma Laboratories, L.P., Fort Worth, TX, United States Effective treatment for acne vulgaris relies on patient compliance for optimal results. Treatment tolerability is central to encouraging patient compliance. Adapalene cream 0.1% is a topical treatment for acne vulgaris that has excellent tolerability and is associated with a low incidence of cutaneous adverse events. Adapalene lotion 0.1% is a new formulation indicated for the topical treatment for acne vulgaris that also had a low incidence of cutaneous irritation in pivotal trials. Two single-center, randomized, evaluator-blinded, split-face comparison studies were conducted to evaluate the tolerability and safety of adapalene lotion 0.1% versus adapalene cream 0.1%. A total of 144 volunteers were enrolled (site 1 ¼ 75 volunteers with a mean age of 42 years, site 2 ¼ 69 volunteers with a mean age of 37 years) across Fitzpatrick skin types I to VI. Healthy volunteers aged $ 18 years applied adapalene cream 0.1% to the right or left side of the face (in a randomized fashion) and applied adapalene lotion 0.1% to the opposite side of the face once daily for 3 consecutive weeks (21 days). Volunteers were asked to complete a cosmetic acceptability questionnaire regarding preference and product aesthetics at the end of treatment. The worst postbaseline local tolerability scores for each parameter (regardless of time point) were evaluated and compared between the two groups. There were no statistically significant differences between adapalene lotion 0.1% and adapalene cream 0.1% in cutaneous irritation. Nine patients experienced 17 AEs that were related to one of the study medications. AEs related to treatment included scaling, dryness, erythema, itching, burning/stinging, and bumps on chin and were experienced for both adapalene lotion and adapalene cream. Lastly, there were no statistically significant differences between the two treatments in subject satisfaction. In conclusion, the results from this study show that tolerability and cosmetic acceptability for adapalene lotion, 0.1% and adapalene cream, 0.1% are similar. Commercial support: Study and poster support provided by Galderma Laboratories, L.P.
FEBRUARY 2011
The use of autologous platelet gel enhances the efficacy of skin needling for the treatment of acne scarring Gabriella Fabbrocini, PhD, University of Naples ‘‘Federico II,’’ Department of Systematic Pathology, Division of Dermatology, Naples, Italy; Antonella Tosti, PhD, Department of Internal Medicine, Geriatrics and Nephrology, Division of Dermatology, University of Bologna, Bologna, Italy; Elio D’Agostino, PhD, University of Naples ‘‘Federico II,’’ Department of Molecular and Cellular Biology and Pathology, Naples, Italy; Luigia Panariello, MD, University of Naples ‘‘Federico II,’’ Department of Sistematic Pathology, Division of Dermatology, Naples, Italy; Rossana Sepulveres, PhD, University of Naples ‘‘Federico II,’’ Department of Molecular and Cellular Biology and Pathology, Naples, Italy Introduction: Acne scarring is difficult to approach for a simple and definitive solution. At present, there are different methods available to treat acne scars. A combination of several treatment procedures could be appropriate, depending on specific patient features. Skin needling is a relatively new technique that is simple and effective for treating acne scars. Autologous platelet gel is created from autologous blood, which is centrifuged to produce a concentrate high in both plasma and platelets that releases the bioactive proteins and growth factors necessary to initiate and accelerate tissue repair and regeneration, improving wound healing. The aim of this study was to show that autologous platelet gel enhances the efficacy of skin needling for the treatment of acne scarring. Methods: Fifteen patients (8 female, 7 males; age range, 18-45 years) with acne rolling scars were included. Each patient underwent two session of treatments, each consisting of skin needling followed by APG application on one side of the face and only skin needling to the other half of face. Using digital cameras, photographs of all patients were taken to evaluate scar depth.The photographic data were analyzed by using the sign test (a \ .05). Results: Analysis of the patient photographs, supported by the sign test showed that after only two sessions, the severity grade of rolling scars in all patients was greatly reduced and there was an overall aesthetic improvement. Conclusion: Skin needling is an appropriate method to treat acne scars. It induces a wound healing response developing in three phases (inflammation, proliferation, and remodeling). During the proliferation phase, several growth factors, including platelet-derived growth factor, fibroblast growth factor, and transforming growth factors alfa and beta are released. Furthermore, this procedure provides a channel for autologous platelet gel to be absorbed more effectively through the top layer of skin. This gel contains autologous growth factors that could act synergistically with growth factors induced by skin needling in order to enhance the wound healing response. The present study shows that the application of an autologous platelet gel enhanced the efficacy of skin needling producing an overall aesthetic improvement, but the improvement was more efficient on the side of the face treated with skin needling and APG application. Commercial support: None identified.
J AM ACAD DERMATOL
AB17