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Efficacy and safety of triple-combination cream versus vehicle cream in the treatment of patients with postinflammatory hyperpigmentation
P2604
P2606
EFFICACY AND SAFETY OF PIMECROLIMUS (ASM 981) CREAM 1% IN THE TREATMENT OF VITILIGO Mona Atwa, MD, Faculty of Medicine, Suez Canal University Egypt, Riyadh, Saudi Arabia, Faculty of Medicine, Suez Canal University, Ismailia, Egypt
EFFICACY AND SAFETY OF TRIPLE-COMBINATION CREAM VERSUS VEHICLE CREAM IN THE TREATMENT OF PATIENTS WITH POSTINFLAMMATORY HYPERPIGMENTATION Leslie Baumann, MD, University of Miami, Florida, Miami, FL, United States
Background: Vitiligo is a common acquired depigmenting disease of the skin and hair. Loss of melanocytes in vitiligo is caused by a cell-mediated immune response to melanocyte differentiation antigens. The ascomycin derivative pimecrolimus (ASM 981) is a nonsteroid that has anti-inflammatory activity and is a cell-selective cytokine inhibitor.
This poster will present the randomized, investigator-blinded, multicenter, parallel studies created to evaluate the safety and efficacy of 4% hydroquinone, 0.05% tretinoin, and 0.01% fluocinolone acetonide combination cream versus vehicle cream for the treatment of postinflammatory hyperpigmentation (PIH) due to acne as well as atopic, allergic, and irritant dermatitis. This 8-week study included male and female patients 18 years of age and older with moderate to severe PIH treated once daily with either the triple-combination cream or vehicle to the affected areas. Primary and secondary efficacy and safety parameters were assessed at baseline and at weeks 1, 2, 4, and 8. A follow-up visit and evaluations were performed at week 12. Severity of the PIH was assessed at baseline by using a 0-3 rating scale and physician static global assessments, and safety evaluations were reported at each visit. This poster will focus on the data collected during this clinical trial, and photographic assessments of patients will be presented.
Objective: The study was conducted to assess the efficacy and safety of pimecrolimus (ASM 981) cream 1% in the treatment of vitiligo. Methods: Twenty patients with vitiligo were included in this study. The study was designed as a randomized, double-blind, right/left comparative trial of pimecrolimus cream 1% and placebo/control vehicle over 8 weeks. Two lesions nearly similar to each other in size and time of evolution were selected to apply either pimecrolimus cream 1% or vehicle. Upon conclusion of the double-blind phase, an 8-week extension was initiated with all lesions treated with open-label pimecrolimus cream 1%. Results: Nineteen of the 20 patients (95%) experienced some repigmentation with pimecrolimus cream 1% during the double-blind phase. The mean percentage of repigmentation was 46.87%. During the open-label phase, there was progressive improvement. Only one patient suffered from burning sensation at the application site.
100% sponsored by Galderma Laboratories
Conclusion: Pimecrolimus cream 1% holds promise as a safe therapeutic alternative for vitiligo. Nothing to disclose.
P2605 EFFICACY AND SAFETY OF TRIPLE COMBINATION CREAM (0.01% FLUOCINOLONE ACETONIDE + 4% HYDROQUINONE + 0.05% TRETINOIN) AND HYDROQUINONE 4% CREAM IN THE TREATMENT OF MODERATE TO SEVERE MELASMA Tania Cestari, MD, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil; Karime Hassun, MD, 2 Universidade Federal de Sao Paulo, Sao Paulo, Brazil; Alexandre Sittart, MD, Hospital do Servidor Publico Estadual, Sao Paulo, Brazil Background: Melasma is a common dermatological disease, occurring in all races, but more commonly in Asian and Hispanic females with dark skin.
P2607
Objective: The aim of this study was to compare the efficacy and safety of a triple combination (TC) cream and hydroquinone 4% (HQ) cream in treatment of moderate to severe facial melasma.
IDENTIFYING AND ADDRESSING COMPLIANCE ISSUES Dina Besece, PharmD, JSJ Pharmaceuticals, Doylestown, PA, United States; Otto Mills, PhD, Robert Wood Johnson Medical School, New Brunswick, NJ, United States
Patients and methods: In total, 120 subjects applied TC cream once daily or HQ cream twice daily for 8 weeks. Evaluations included static global severity assessment of melasma, improvement of melasma over time, local tolerability, and adverse events. Results: TC cream was significantly more effective than HQ cream from week 4 onwards. A total of 35% of all TC-treated subjects had melasma lesions approximately equivalent to surrounding skin compared with 5% of HQ cream subjects (P = .0001). Improvement of more than 75% was achieved for 73% of TC cream subjects and 49% of HQ cream subjects (P = .007). The incidence of adverse events (Aes) was similar in both groups with erythema, burning sensation, and desquamation. No subject discontinued the study because of drug-related AEs. Conclusion: TC cream was more effective than the HQ cream for the treatment of moderate to severe facial melasma. Both products had similar safety profiles. Supported by Galderma Brazil
P168
J AM ACAD DERMATOL
Dermatology has many common chronic conditions that may require gradual topical applications. Understanding issues that are important to help the patient comply and then linking these to product development technologies can be rewarding for all. To look at the compliance aspect of treatment, we selected issues surrounding the use of hydroquinone. A brief review of the indications and clinical pharmacology of hydroquinone will preface a step-by-step outline of ways to encourage patient compliance. Included is consideration of oxidation, inclusion of sunscreens, medication dispersal, as well as cosmetic and sensory issues. This presentation will help the clinician to understand some of the issues that may be important for patient compliance and what to look for in new products. Otto Mills-consultant 100% supported JSJ Pharmaceuticals
MARCH 2005
P2606
EFFICACY AND SAFETY OF PIMECROLIMUS (ASM 981) CREAM 1% IN THE TREATMENT OF VITILIGO Mona Atwa, MD, Faculty of Medicine, Suez Canal University Egypt, Riyadh, Saudi Arabia, Faculty of Medicine, Suez Canal University, Ismailia, Egypt
EFFICACY AND SAFETY OF TRIPLE-COMBINATION CREAM VERSUS VEHICLE CREAM IN THE TREATMENT OF PATIENTS WITH POSTINFLAMMATORY HYPERPIGMENTATION Leslie Baumann, MD, University of Miami, Florida, Miami, FL, United States
Background: Vitiligo is a common acquired depigmenting disease of the skin and hair. Loss of melanocytes in vitiligo is caused by a cell-mediated immune response to melanocyte differentiation antigens. The ascomycin derivative pimecrolimus (ASM 981) is a nonsteroid that has anti-inflammatory activity and is a cell-selective cytokine inhibitor.
This poster will present the randomized, investigator-blinded, multicenter, parallel studies created to evaluate the safety and efficacy of 4% hydroquinone, 0.05% tretinoin, and 0.01% fluocinolone acetonide combination cream versus vehicle cream for the treatment of postinflammatory hyperpigmentation (PIH) due to acne as well as atopic, allergic, and irritant dermatitis. This 8-week study included male and female patients 18 years of age and older with moderate to severe PIH treated once daily with either the triple-combination cream or vehicle to the affected areas. Primary and secondary efficacy and safety parameters were assessed at baseline and at weeks 1, 2, 4, and 8. A follow-up visit and evaluations were performed at week 12. Severity of the PIH was assessed at baseline by using a 0-3 rating scale and physician static global assessments, and safety evaluations were reported at each visit. This poster will focus on the data collected during this clinical trial, and photographic assessments of patients will be presented.
Objective: The study was conducted to assess the efficacy and safety of pimecrolimus (ASM 981) cream 1% in the treatment of vitiligo. Methods: Twenty patients with vitiligo were included in this study. The study was designed as a randomized, double-blind, right/left comparative trial of pimecrolimus cream 1% and placebo/control vehicle over 8 weeks. Two lesions nearly similar to each other in size and time of evolution were selected to apply either pimecrolimus cream 1% or vehicle. Upon conclusion of the double-blind phase, an 8-week extension was initiated with all lesions treated with open-label pimecrolimus cream 1%. Results: Nineteen of the 20 patients (95%) experienced some repigmentation with pimecrolimus cream 1% during the double-blind phase. The mean percentage of repigmentation was 46.87%. During the open-label phase, there was progressive improvement. Only one patient suffered from burning sensation at the application site.
100% sponsored by Galderma Laboratories
Conclusion: Pimecrolimus cream 1% holds promise as a safe therapeutic alternative for vitiligo. Nothing to disclose.
P2605 EFFICACY AND SAFETY OF TRIPLE COMBINATION CREAM (0.01% FLUOCINOLONE ACETONIDE + 4% HYDROQUINONE + 0.05% TRETINOIN) AND HYDROQUINONE 4% CREAM IN THE TREATMENT OF MODERATE TO SEVERE MELASMA Tania Cestari, MD, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil; Karime Hassun, MD, 2 Universidade Federal de Sao Paulo, Sao Paulo, Brazil; Alexandre Sittart, MD, Hospital do Servidor Publico Estadual, Sao Paulo, Brazil Background: Melasma is a common dermatological disease, occurring in all races, but more commonly in Asian and Hispanic females with dark skin.
P2607
Objective: The aim of this study was to compare the efficacy and safety of a triple combination (TC) cream and hydroquinone 4% (HQ) cream in treatment of moderate to severe facial melasma.
IDENTIFYING AND ADDRESSING COMPLIANCE ISSUES Dina Besece, PharmD, JSJ Pharmaceuticals, Doylestown, PA, United States; Otto Mills, PhD, Robert Wood Johnson Medical School, New Brunswick, NJ, United States
Patients and methods: In total, 120 subjects applied TC cream once daily or HQ cream twice daily for 8 weeks. Evaluations included static global severity assessment of melasma, improvement of melasma over time, local tolerability, and adverse events. Results: TC cream was significantly more effective than HQ cream from week 4 onwards. A total of 35% of all TC-treated subjects had melasma lesions approximately equivalent to surrounding skin compared with 5% of HQ cream subjects (P = .0001). Improvement of more than 75% was achieved for 73% of TC cream subjects and 49% of HQ cream subjects (P = .007). The incidence of adverse events (Aes) was similar in both groups with erythema, burning sensation, and desquamation. No subject discontinued the study because of drug-related AEs. Conclusion: TC cream was more effective than the HQ cream for the treatment of moderate to severe facial melasma. Both products had similar safety profiles. Supported by Galderma Brazil
P168
J AM ACAD DERMATOL
Dermatology has many common chronic conditions that may require gradual topical applications. Understanding issues that are important to help the patient comply and then linking these to product development technologies can be rewarding for all. To look at the compliance aspect of treatment, we selected issues surrounding the use of hydroquinone. A brief review of the indications and clinical pharmacology of hydroquinone will preface a step-by-step outline of ways to encourage patient compliance. Included is consideration of oxidation, inclusion of sunscreens, medication dispersal, as well as cosmetic and sensory issues. This presentation will help the clinician to understand some of the issues that may be important for patient compliance and what to look for in new products. Otto Mills-consultant 100% supported JSJ Pharmaceuticals
MARCH 2005