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Maintaining remission of melasma with triple-combination cream therapy
P2608
P2610
MAINTAINING REMISSION OF MELASMA WITH TRIPLE-COMBINATION CREAM THERAPY Valerie Callender, MD, Howard University College of Medicine, Mitchellville, MD, United States; Cherie Young, MD, Callender Skin & Laser, Mitchellville, MD, United States
NIACINAMIDE: REVERSIBILITY OF REDUCTION OF FACIAL HYPERPIGMENTED SPOTS Tomohiro Hakozaki, Procter & Gamble, Kobe, Japan; Don Bissett, The Procter & Gamble Company, Cincinnati, OH, United States; Ray Boissy, Amanda Greatens, University of Cincinnati, Cincinnati, OH, United States
The only available triple-combination prescription treatment for melasma consists of hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01% in a cream base. Clinical trials and office-based experience have shown it to be highly effective in this skin disease. Following the approval of the triple-combination cream by the Food and Drug Administration, a long-term study of its safety and efficacy over a 12month period was conducted in patients who had been treated in the phase III clinical trials. This study found that the triple-combination cream was both safe and efficacious for long-term use. Although on average patients required only 2 treatment courses during the study to control their melasma, each time treatment was reinitiated for a shorter duration to achieve the desired result. Because melasma is a chronic, relapsing disorder, maintenance therapy is important for remission achieved with initial treatment. Sun protection and sun avoidance are also essential aspects of melasma maintenance. This poster will present data from a small case study of patients that utilized intermittent and long-term therapy with the triple-combination cream to maintain melasma clearance and prevent recurrence.
Previous work has revealed that niacinamide can suppress the transfer of melanosomes in a dose-dependent and reversible manner using a melanocytekeratinocyte co-culture model. Other work has also revealed that niacinamidecontaining products reduce the appearance of facial hyperpigmented spots. The clinical work reported here was done to evaluate dose-response and reversibility of the reduction effect in a left/right randomized, vehicle-controlled, split-face design, human clinical trial. Seventy-nine Japanese women, 28 to 54 years of age, with multiple types of brown hyperpigmentation on both sides of the face were assigned to one of two groups of either 39 or 40 subjects. Group 1 (n = 39) utilized 5% niacinamide in a moisturizer to one side of the face versus the vehicle moisturizer (without niacinamide) to the other side of the face, and group 2 (n = 40) utilized 2% niacinamide moisturizer versus the vehicle moisturizer twice daily for 8 weeks. The group that received the 5% niacinamide-containing product (group 1) was monitored for an additional 34 weeks after the treatment period to determine reversibility of the spot appearance reduction effect (recovery period:, n = 37 completed). Facial hyperpigmented spots were objectively quantified by computer analysis (spot area) and visual grading (spot severity) of acquired high-resolution digital images of the right and left sides of the face. As a result, the effect of the topical niacinamide-containing product on hyperpigmented facial spots was demonstrated with 2% and 5% niacinamide in an abbreviated dose-response manner. In addition, the effect of niacinamide was shown to be reversible since discontinuation of the niacinamide-containing product use resulted in normalization of hyperpigmented facial spots toward the vehicle control. Thus continued use of product is necessary to maintain the appearance improvement effect. These clinical results are consistent with previous in vitro reversibility results and suggest that the effect of niacinamide on the appearance of skin pigmentation is dose dependent and reversible.
100% supported by Galderma
Nothing to disclose.
P2611 OPEN-LABEL CASE STUDY ON TRIPLE-COMBINATION CREAM IN PATIENTS WITH PSEUDOFOLLICULITIS BARBAE Susan Taylor, MD, Dermatology Associates, St. Luke’s-Roosevelt Hospital, Philadelphia, PA, United States
P2609 NEW COMBINED PEEL IN MELASMA Antonella Tosti, MD, Maria Pia De Padova, Nicola Venturo, Margherita Bentivogli, Department of Dermatology, University of Bologna, Bologna, Italy Background: Melasma is a common skin hyperpigmentation disorder, occurring most often in adult women, that is difficult to resolve with dermocosmetic therapy. Objective: The purpose of our study was to evaluate the efficacy and tolerability of a combined peel, using salicylic acid associated with trichloroacetic acid (TCA) at low concentration, in the treatment of melasma. Materials and methods: Our aim in using this combination peel is to enable penetration of TCA at low concentration, using salicylic acid as an exfoliant agent. We treated 20 female patients with the combined peel using salicylic acid 25% in alcoholic solution and TCA 10% gel, in 3 to 4 settings at 4- to 5-week intervals; 12 patients had epidermal melasma and 8 patients had mixed melasma. Results: Results were evaluated 3 months after the beginning of treatment. All 12 patients with epidermal melasma had complete regression of skin hyperpigmentation. All 8 patients with mixed melasma had significant reduction of hyperpigmentation. No side effects were observed either during or after the treatment. In patients with total resolution, no relapses were observed after 6 months from the end of treatment with chemical peeling. Conclusion: The main advantage of combined peel is the lack of inflammatory reaction that could cause postinflammatory hyperpigmentation. Combined peels are therefore also safe for patients with high Fitzpatrick skin phototypes. Supported by Sipharma
MARCH 2005
Background: A topical cream combining fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% has demonstrated efficacy in the treatment of moderate to severe melasma, and the triple action of this formulation may prove efficacious in the treatment of pseudofolliculitis barbae (PFB). PFB is a condition characterized by papules and pustules with resultant postinflammatory hyperpigmentation (PIH) in the distribution of hair growth. PFB is due to a curved hair follicle producing a curved hair that grows into the epidermis, producing a foreign body reaction. Tretinoin has demonstrated a keratolytic effect that is useful in releasing the ingrown hair. Hydroquinone disrupts the tyrosine/tyrosinase pathway of melanin production, which is important in lightening PIH. The anti-inflammatory effect of the steroid fluocinolone acetonide can help reduce inflammation-induced hyperpigmentation. Objective: The objective of this study is to assess the efficacy and safety of fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream in the treatment of moderate to severe PFB. Methods: This was a single-center, open-label study. Male and female patients aged 18 years or older with moderate to severe PFB (>12 papules and/or pustules and a PIH severity score of at least 2) were eligible for inclusion. Pregnant or nursing mothers were excluded because of the possible toxic effects of the study cream in infants. Patients entered a washout period if previously receiving topical or systemic treatments. Patients were treated with fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream once a day for 12 weeks in addition to the daily application of a broad-spectrum sunblock of SPF 30 or higher. Investigator-rated efficacy variables were assessed at baseline, 6, and 12 weeks. Primary efficacy endpoints were the reduction in papule and/or pustule count in beard distribution and the severity of PFB using a 0-3 rating scale. Secondary endpoints included investigator’s global assessment from baseline in PFB and hyperpigmentation (6point scale), and patient’s global assessment of improvement from baseline (5-point scale). Treatment-related adverse events were recorded throughout the study period. Results: This poster presents the key efficacy and safety findings from this small, open-label case study of fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream in the treatment of moderate to severe PFB. Galderma Laboratories, L.P., Johnson & Johnson Consumer Products, Medicis 100% supported by Galderma Laboratories, L.P.
J AM ACAD DERMATOL
P169
P2610
MAINTAINING REMISSION OF MELASMA WITH TRIPLE-COMBINATION CREAM THERAPY Valerie Callender, MD, Howard University College of Medicine, Mitchellville, MD, United States; Cherie Young, MD, Callender Skin & Laser, Mitchellville, MD, United States
NIACINAMIDE: REVERSIBILITY OF REDUCTION OF FACIAL HYPERPIGMENTED SPOTS Tomohiro Hakozaki, Procter & Gamble, Kobe, Japan; Don Bissett, The Procter & Gamble Company, Cincinnati, OH, United States; Ray Boissy, Amanda Greatens, University of Cincinnati, Cincinnati, OH, United States
The only available triple-combination prescription treatment for melasma consists of hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01% in a cream base. Clinical trials and office-based experience have shown it to be highly effective in this skin disease. Following the approval of the triple-combination cream by the Food and Drug Administration, a long-term study of its safety and efficacy over a 12month period was conducted in patients who had been treated in the phase III clinical trials. This study found that the triple-combination cream was both safe and efficacious for long-term use. Although on average patients required only 2 treatment courses during the study to control their melasma, each time treatment was reinitiated for a shorter duration to achieve the desired result. Because melasma is a chronic, relapsing disorder, maintenance therapy is important for remission achieved with initial treatment. Sun protection and sun avoidance are also essential aspects of melasma maintenance. This poster will present data from a small case study of patients that utilized intermittent and long-term therapy with the triple-combination cream to maintain melasma clearance and prevent recurrence.
Previous work has revealed that niacinamide can suppress the transfer of melanosomes in a dose-dependent and reversible manner using a melanocytekeratinocyte co-culture model. Other work has also revealed that niacinamidecontaining products reduce the appearance of facial hyperpigmented spots. The clinical work reported here was done to evaluate dose-response and reversibility of the reduction effect in a left/right randomized, vehicle-controlled, split-face design, human clinical trial. Seventy-nine Japanese women, 28 to 54 years of age, with multiple types of brown hyperpigmentation on both sides of the face were assigned to one of two groups of either 39 or 40 subjects. Group 1 (n = 39) utilized 5% niacinamide in a moisturizer to one side of the face versus the vehicle moisturizer (without niacinamide) to the other side of the face, and group 2 (n = 40) utilized 2% niacinamide moisturizer versus the vehicle moisturizer twice daily for 8 weeks. The group that received the 5% niacinamide-containing product (group 1) was monitored for an additional 34 weeks after the treatment period to determine reversibility of the spot appearance reduction effect (recovery period:, n = 37 completed). Facial hyperpigmented spots were objectively quantified by computer analysis (spot area) and visual grading (spot severity) of acquired high-resolution digital images of the right and left sides of the face. As a result, the effect of the topical niacinamide-containing product on hyperpigmented facial spots was demonstrated with 2% and 5% niacinamide in an abbreviated dose-response manner. In addition, the effect of niacinamide was shown to be reversible since discontinuation of the niacinamide-containing product use resulted in normalization of hyperpigmented facial spots toward the vehicle control. Thus continued use of product is necessary to maintain the appearance improvement effect. These clinical results are consistent with previous in vitro reversibility results and suggest that the effect of niacinamide on the appearance of skin pigmentation is dose dependent and reversible.
100% supported by Galderma
Nothing to disclose.
P2611 OPEN-LABEL CASE STUDY ON TRIPLE-COMBINATION CREAM IN PATIENTS WITH PSEUDOFOLLICULITIS BARBAE Susan Taylor, MD, Dermatology Associates, St. Luke’s-Roosevelt Hospital, Philadelphia, PA, United States
P2609 NEW COMBINED PEEL IN MELASMA Antonella Tosti, MD, Maria Pia De Padova, Nicola Venturo, Margherita Bentivogli, Department of Dermatology, University of Bologna, Bologna, Italy Background: Melasma is a common skin hyperpigmentation disorder, occurring most often in adult women, that is difficult to resolve with dermocosmetic therapy. Objective: The purpose of our study was to evaluate the efficacy and tolerability of a combined peel, using salicylic acid associated with trichloroacetic acid (TCA) at low concentration, in the treatment of melasma. Materials and methods: Our aim in using this combination peel is to enable penetration of TCA at low concentration, using salicylic acid as an exfoliant agent. We treated 20 female patients with the combined peel using salicylic acid 25% in alcoholic solution and TCA 10% gel, in 3 to 4 settings at 4- to 5-week intervals; 12 patients had epidermal melasma and 8 patients had mixed melasma. Results: Results were evaluated 3 months after the beginning of treatment. All 12 patients with epidermal melasma had complete regression of skin hyperpigmentation. All 8 patients with mixed melasma had significant reduction of hyperpigmentation. No side effects were observed either during or after the treatment. In patients with total resolution, no relapses were observed after 6 months from the end of treatment with chemical peeling. Conclusion: The main advantage of combined peel is the lack of inflammatory reaction that could cause postinflammatory hyperpigmentation. Combined peels are therefore also safe for patients with high Fitzpatrick skin phototypes. Supported by Sipharma
MARCH 2005
Background: A topical cream combining fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% has demonstrated efficacy in the treatment of moderate to severe melasma, and the triple action of this formulation may prove efficacious in the treatment of pseudofolliculitis barbae (PFB). PFB is a condition characterized by papules and pustules with resultant postinflammatory hyperpigmentation (PIH) in the distribution of hair growth. PFB is due to a curved hair follicle producing a curved hair that grows into the epidermis, producing a foreign body reaction. Tretinoin has demonstrated a keratolytic effect that is useful in releasing the ingrown hair. Hydroquinone disrupts the tyrosine/tyrosinase pathway of melanin production, which is important in lightening PIH. The anti-inflammatory effect of the steroid fluocinolone acetonide can help reduce inflammation-induced hyperpigmentation. Objective: The objective of this study is to assess the efficacy and safety of fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream in the treatment of moderate to severe PFB. Methods: This was a single-center, open-label study. Male and female patients aged 18 years or older with moderate to severe PFB (>12 papules and/or pustules and a PIH severity score of at least 2) were eligible for inclusion. Pregnant or nursing mothers were excluded because of the possible toxic effects of the study cream in infants. Patients entered a washout period if previously receiving topical or systemic treatments. Patients were treated with fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream once a day for 12 weeks in addition to the daily application of a broad-spectrum sunblock of SPF 30 or higher. Investigator-rated efficacy variables were assessed at baseline, 6, and 12 weeks. Primary efficacy endpoints were the reduction in papule and/or pustule count in beard distribution and the severity of PFB using a 0-3 rating scale. Secondary endpoints included investigator’s global assessment from baseline in PFB and hyperpigmentation (6point scale), and patient’s global assessment of improvement from baseline (5-point scale). Treatment-related adverse events were recorded throughout the study period. Results: This poster presents the key efficacy and safety findings from this small, open-label case study of fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream in the treatment of moderate to severe PFB. Galderma Laboratories, L.P., Johnson & Johnson Consumer Products, Medicis 100% supported by Galderma Laboratories, L.P.
J AM ACAD DERMATOL
P169