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Efficacy of a skin lightening regimen to improve melasma
P2603
P2605
A double-blind randomized trial of 1% pimecrolimus versus 0.05% clobetasol propionate for the treatment of vitiligo Deniz Seckin, MD, Baskent University School of Medicine, Ankara, Turkey; Aydolu Eryilmaz, MD, Baskent University School of Medicine, Dept. of General Surgery, Ankara, Turkey; Mete Baba, MD, Baskent University School of Medicine, Dept. of General Surgery, Ankara, Turkey Background: Topical corticosteroids and phototherapy are the most common treatment modalities prescribed in patients with vitiligo. However, they are often not effective and safe. Therefore, research for alternative therapies continues. Pimecrolimus is a topical immunomodulator agent used mainly in atopic dermatitis. Previously, only one case report and one study showed the efficacy of pimecrolimus in the treatment of vitiligo.
Phase II management of vitiligo with 5% polyphenone (-EGCg) in a hydrophilic cream. A placebo-controlled, double-blind study Tanweer Syed, MD, PhD, Syed Skin Care Inc., San Francisco, CA, United States; Seyed Ali Ahmad, University of California, Berkeley, CA, United States; Raza Aly, MD, PhD, MPH, University of California, San Francisco, CA, United States; Vishal Govil, University of California, Davis, CA, United States Objective: To evaluate the clinical efficacy, tolerability, safety, and beneficial effects of 5% polyphenone (-EGCg, epigallocatechin gallate) incorporated in a hydrophilic cream to cure vitiligo (Leukoderma). Methods: Preselected subjects (n = 120, 89M/31F) aged 15-70 years showing visible clinical signs of vitiligo were sequentially randomized into 2 parallel groups. Each patient was allocated an identical precoded tube containing 50-g (either active or placebo) with instructions on how to topically apply the trial cream 2 times a day for 8 weeks. Cure was defined as repigmentation of treated sites. Photographic and optical techniques were used both at the baseline and on weekly basis.
Objective: In this prospective, double-blind clinical study, we aimed to compare the efficacy and safety of topical 1% pimecrolimus with those of topical 0.05% clobetasol propionate in the treatment of vitiligo. Methods: Sixteen patients were enrolled in the study. In each patient, 2 lesions similar in size and time of disease-onset were selected to be applied either 1% pimecrolimus or 0.05% clobetasol propionate twice a day, in a double-blind randomized way. Repigmentation and adverse effects were evaluated at every 2 weeks for 8 weeks. Percentages of repigmentation and the adverse effects were compared at the end of the study. Results: Thirteen (92.8%) of 14 patients who completed the study period experienced some repigmentation with clobetasol propionate and 9 (64.2%) with pimecrolimus. The mean percentage of repigmentation was 57.7% for clobetasol propionate and 32.1% for pimecrolimus (p \ 0.05). There was no adverse effect with pimecrolimus, however, clobetasol propionate led to adverse effects in 3 (21.4%) patients, namely atrophy in lesion #1, atrophy and telangiectasia in lesion #2, and atrophy and acneiform changes in lesion #3.
Results: By the end of the study 35.0% patients showed visible repigmentation in both the groups. Breaking the code disclosed that 5% polyphenone in a hydrophilic cream yielded statistically significantly higher repigmentation in mean count than placebo. Using the investigator’s global assessment, therapeutic success in terms of a clear repigmentation was documented in 61.6% of patients treated with 5% polyphenone (-) EGCg cream, P \ 0.0001. Conclusion: The study states that 5% polyphenone (-) EGCg in a hydrophilic cream is safe, tolerable, and significantly more beneficial in contributing superior clinical efficacy of repigmentation than placebo to cure vitiligo. 75% is sponsored by Syed Skin Care Inc.
Conclusions: Although, some efficacy can be obtained with pimecrolimus, it is less efficacious than clobatesol propionate in the treatment of vitiligo. However, pimecrolimus may be a safe alternative for a long term vitiligo treatment. Commercial support: None identified.
P2606
P2604 Efficacy of a skin lightening regimen to improve melasma Hanh Pham, MS, Mary Kay, Inc., Addison, TX, United States; Pearl Grimes, MD, Vitiligo & Pigmentation Institute, Los Angeles, CA, United States; Aruna Parikh, PhD, Vitiligo & Pigmentation Institute, Los Angeles, CA, United States; Brian Jones, PhD, Mary Kay, Inc., Addison, TX, United States Melasma is a common disorder of hyper-pigmentation. It is characterized by symmetrical brown-grey pigmentation affecting the cheeks, forehead, upper lips, and chin. It impacts all women, although the disease is more commonly observed in darker racial-ethnic groups (Fitzpatrick’s Skin Types IV-VI). The condition is more common in areas with intense ultraviolet light exposure. The purpose of this study was to clinically evaluate for the efficacy of skin lightening products to elicit an improvement in facial attributes associated with melasma. In this baseline controlled study, 38 subjects applied the skin lightening regimen for 12 weeks. Visual assessments by a dermatologist were evaluated at baseline, week 4, 8, and 12 for the following attributes: melasma area and severity index (MASI), disease severity, lesion area, and pigmentary intensity score. Additionally, mexameter readings were taken at the same visits, baseline, 4, 8, and 12 weeks. Further, photographs were taken at baseline and week 12. The results showed the skin lightening regimen significantly improved melasma. Commercial support: None identified.
AB170
J AM ACAD DERMATOL
FEBRUARY 2007
P2605
A double-blind randomized trial of 1% pimecrolimus versus 0.05% clobetasol propionate for the treatment of vitiligo Deniz Seckin, MD, Baskent University School of Medicine, Ankara, Turkey; Aydolu Eryilmaz, MD, Baskent University School of Medicine, Dept. of General Surgery, Ankara, Turkey; Mete Baba, MD, Baskent University School of Medicine, Dept. of General Surgery, Ankara, Turkey Background: Topical corticosteroids and phototherapy are the most common treatment modalities prescribed in patients with vitiligo. However, they are often not effective and safe. Therefore, research for alternative therapies continues. Pimecrolimus is a topical immunomodulator agent used mainly in atopic dermatitis. Previously, only one case report and one study showed the efficacy of pimecrolimus in the treatment of vitiligo.
Phase II management of vitiligo with 5% polyphenone (-EGCg) in a hydrophilic cream. A placebo-controlled, double-blind study Tanweer Syed, MD, PhD, Syed Skin Care Inc., San Francisco, CA, United States; Seyed Ali Ahmad, University of California, Berkeley, CA, United States; Raza Aly, MD, PhD, MPH, University of California, San Francisco, CA, United States; Vishal Govil, University of California, Davis, CA, United States Objective: To evaluate the clinical efficacy, tolerability, safety, and beneficial effects of 5% polyphenone (-EGCg, epigallocatechin gallate) incorporated in a hydrophilic cream to cure vitiligo (Leukoderma). Methods: Preselected subjects (n = 120, 89M/31F) aged 15-70 years showing visible clinical signs of vitiligo were sequentially randomized into 2 parallel groups. Each patient was allocated an identical precoded tube containing 50-g (either active or placebo) with instructions on how to topically apply the trial cream 2 times a day for 8 weeks. Cure was defined as repigmentation of treated sites. Photographic and optical techniques were used both at the baseline and on weekly basis.
Objective: In this prospective, double-blind clinical study, we aimed to compare the efficacy and safety of topical 1% pimecrolimus with those of topical 0.05% clobetasol propionate in the treatment of vitiligo. Methods: Sixteen patients were enrolled in the study. In each patient, 2 lesions similar in size and time of disease-onset were selected to be applied either 1% pimecrolimus or 0.05% clobetasol propionate twice a day, in a double-blind randomized way. Repigmentation and adverse effects were evaluated at every 2 weeks for 8 weeks. Percentages of repigmentation and the adverse effects were compared at the end of the study. Results: Thirteen (92.8%) of 14 patients who completed the study period experienced some repigmentation with clobetasol propionate and 9 (64.2%) with pimecrolimus. The mean percentage of repigmentation was 57.7% for clobetasol propionate and 32.1% for pimecrolimus (p \ 0.05). There was no adverse effect with pimecrolimus, however, clobetasol propionate led to adverse effects in 3 (21.4%) patients, namely atrophy in lesion #1, atrophy and telangiectasia in lesion #2, and atrophy and acneiform changes in lesion #3.
Results: By the end of the study 35.0% patients showed visible repigmentation in both the groups. Breaking the code disclosed that 5% polyphenone in a hydrophilic cream yielded statistically significantly higher repigmentation in mean count than placebo. Using the investigator’s global assessment, therapeutic success in terms of a clear repigmentation was documented in 61.6% of patients treated with 5% polyphenone (-) EGCg cream, P \ 0.0001. Conclusion: The study states that 5% polyphenone (-) EGCg in a hydrophilic cream is safe, tolerable, and significantly more beneficial in contributing superior clinical efficacy of repigmentation than placebo to cure vitiligo. 75% is sponsored by Syed Skin Care Inc.
Conclusions: Although, some efficacy can be obtained with pimecrolimus, it is less efficacious than clobatesol propionate in the treatment of vitiligo. However, pimecrolimus may be a safe alternative for a long term vitiligo treatment. Commercial support: None identified.
P2606
P2604 Efficacy of a skin lightening regimen to improve melasma Hanh Pham, MS, Mary Kay, Inc., Addison, TX, United States; Pearl Grimes, MD, Vitiligo & Pigmentation Institute, Los Angeles, CA, United States; Aruna Parikh, PhD, Vitiligo & Pigmentation Institute, Los Angeles, CA, United States; Brian Jones, PhD, Mary Kay, Inc., Addison, TX, United States Melasma is a common disorder of hyper-pigmentation. It is characterized by symmetrical brown-grey pigmentation affecting the cheeks, forehead, upper lips, and chin. It impacts all women, although the disease is more commonly observed in darker racial-ethnic groups (Fitzpatrick’s Skin Types IV-VI). The condition is more common in areas with intense ultraviolet light exposure. The purpose of this study was to clinically evaluate for the efficacy of skin lightening products to elicit an improvement in facial attributes associated with melasma. In this baseline controlled study, 38 subjects applied the skin lightening regimen for 12 weeks. Visual assessments by a dermatologist were evaluated at baseline, week 4, 8, and 12 for the following attributes: melasma area and severity index (MASI), disease severity, lesion area, and pigmentary intensity score. Additionally, mexameter readings were taken at the same visits, baseline, 4, 8, and 12 weeks. Further, photographs were taken at baseline and week 12. The results showed the skin lightening regimen significantly improved melasma. Commercial support: None identified.
AB170
J AM ACAD DERMATOL
FEBRUARY 2007