RESUMO
The purpose of this study was to assess the cosmetic appearance of commonly marketed facial cosmetics when used after the application of metronidazole gel 1%. An observational. open-label, single-site study was conducted with women (N=30) aged 20 to 75 years and diagnosed with moderate papulopustular rosacea (investigator global severity score of 3). After cleansing the face with a gentle skin cleanser, participants applied metronidazole gel 1% once daily before applying their usual facial foundation. Two surveys were conducted: (1) investigator assessment of cosmetic appearance; and (2) participant assessment of cosmetic appearance. The investigator also evaluated erythema, disease severity, and tolerability at baseline and week 2. Adverse events were collected. The 28 per-protocol (PP) participants had a mean age (standard deviation [SD]) of 54.0 (10.3) years and a mean duration (SD) of rosacea of 15.4 (13.2) years. The median response score for both the investigator and participant assessments of cosmetic appearance was 10 (best) for each survey question. Signs and symptoms of rosacea did not increase with use of metronidazole gel 1% and the participants' selected cosmetic regimen. At baseline all 28 participants were classified as having moderate erythema. At week 2, 18 (64%) participants were classified as having moderate erythema and 10 (36%) mild. At baseline all 28 (100%) participants were classified as having moderate rosacea according to the investigator global severity score. At week 2, 10 (36%) participants were classified as mild and 18 (64%) moderate. In addition, few participants reported cutaneous irritation during the study. At week 2, 10 participants had dryness, 2 had itching, 8 had scaling, and 2 had stinging/burning. According to surveys completed by the investigator and the participants themselves, most participants had a good cosmetic appearance with their facial foundation cosmetics that were applied after metronidazole gel 1%. The use of various cosmetic regimens after application of metronidazole gel 1% did not cause rosacea symptoms to worsen and treatment was well-tolerated.
Assuntos
Cosméticos/administração & dosagem , Fármacos Dermatológicos/administração & dosagem , Metronidazol/administração & dosagem , Rosácea/tratamento farmacológico , Administração Cutânea , Adulto , Idoso , Cosméticos/efeitos adversos , Cosméticos/química , Fármacos Dermatológicos/efeitos adversos , Fármacos Dermatológicos/uso terapêutico , Eritema/etiologia , Feminino , Géis , Humanos , Metronidazol/efeitos adversos , Metronidazol/uso terapêutico , Pessoa de Meia-Idade , Rosácea/patologia , Índice de Gravidade de Doença , Adulto JovemRESUMO
BACKGROUND: Triple combination (TC) cream is a stable combination of fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% and is currently the only hydroquinone-containing drug approved by the Food and Drug Administration for the treatment of melasma. OBJECTIVE: To evaluate the safety and efficacy of TC cream when used sequentially with intense pulsed light (IPL) treatments in patients with moderate to severe melasma. MATERIALS & METHODS: This was a 10-week, split-face study in which 56 patients with symmetrical melasma lesions were treated with TC cream on one side of the face and an inactive control cream on the other side of the face. Patients also had two IPL treatments at weeks 2 and 6. (Topical treatment was suspended during IPL treatments ± 1 day.) RESULTS: Melasma severity was significantly less with TC cream and IPL than with inactive cream and IPL at weeks 6 (p=.007) and 10 (p=.002). Improvement in melasma was greater with TC cream and IPL than with inactive cream and IPL according to investigator and patient evaluations at weeks 6 and 10 (p<.001 for both time points). Treatment with TC cream and IPL was well tolerated. CONCLUSION: The results of this study suggest that TC cream and IPL treatment is an effective and safe treatment option for patients with melasma.
Assuntos
Fluocinolona Acetonida/administração & dosagem , Hidroquinonas/administração & dosagem , Terapia com Luz de Baixa Intensidade , Melanose/terapia , Tretinoína/administração & dosagem , Adulto , Idoso , Anti-Inflamatórios/administração & dosagem , Terapia Combinada , Feminino , Humanos , Ceratolíticos/administração & dosagem , Masculino , Melanose/patologia , Pessoa de Meia-Idade , Protetores contra Radiação/administração & dosagemRESUMO
Melasma is a common disorder affecting a significant percentage of the population, particularly those with skin of color. Therapy with hydroquinone, a depigmenting agent, as a single agent or in combination with other agents has been used with variable success. A triple-combination (TC) cream combining hydroquinone 4% with tretinoin 0.05% and fluocinolone acetonide 0.01% was developed for the treatment of melasma. We studied the use of TC cream for 24 weeks and had tissue samples for all time points in 62 patients with moderate to severe melasma. The atrophogenic potential of TC cream was evaluated through serial histopathologic examination of skin biopsies. No statistically significant histopathologic signs of atrophy of the epidermis or dermis were noted at any time point throughout the study. There was a marked reduction in epidermal melanin in treated subjects; however, we did not observe any significant difference in baseline and treated samples in the amount of perivascular inflammatory infiltrate, dermal mucin, keratinocyte and melanocyte atypia, or mast cells, consistent with findings of previous studies where topical retinoids were used. An increase in the mean number of blood vessels per square millimeter of tissue was observed in 2 study cohorts between baseline and week 24. These results suggest that the risk of skin atrophy with 24-week use of TC cream for the treatment of melasma is very low.
Assuntos
Fármacos Dermatológicos/efeitos adversos , Fluocinolona Acetonida/efeitos adversos , Hidroquinonas/efeitos adversos , Melanose/tratamento farmacológico , Pele/patologia , Tretinoína/efeitos adversos , Administração Cutânea , Adulto , Atrofia , Fármacos Dermatológicos/administração & dosagem , Combinação de Medicamentos , Feminino , Fluocinolona Acetonida/administração & dosagem , Humanos , Hidroquinonas/administração & dosagem , Masculino , Pessoa de Meia-Idade , Tretinoína/administração & dosagemRESUMO
Topical therapy for rosacea aims to reduce inflammatory lesions and decrease erythema but can carry side effects such as stinging, pruritus, and burning. Metronidazole and azelaic acid gel 15% are U.S. Food and Drug Administration-approved for the treatment of rosacea. The current study was conducted to assess the cumulative irritation potential of 2 formulations of metronidazole 0.75% gel and 1% gel--and azelaic acid gel 15% over 21 days (N=36). Results of this study demonstrated a significantly greater poten tial for irritation from azelaic acid compared with metronidazole gel 0.75% (P < .0001), which had significantly greater potential for irritation compared with metronidazole gel 1% (P = .0054). Metronidazole gel 1% had a similar profile to white petrolatum.
Assuntos
Fármacos Dermatológicos/efeitos adversos , Ácidos Dicarboxílicos/efeitos adversos , Toxidermias/etiologia , Metronidazol/efeitos adversos , Rosácea/tratamento farmacológico , Administração Tópica , Adulto , Fármacos Dermatológicos/administração & dosagem , Ácidos Dicarboxílicos/administração & dosagem , Feminino , Géis , Humanos , Masculino , Metronidazol/administração & dosagem , Pessoa de Meia-Idade , Método Simples-CegoRESUMO
BACKGROUND: Natural killer (NK) cells are a third population of lymphocytes that can kill certain tumor cells. This killing is regulated by signals received through activating and inhibitory receptors. 2B4 (CD244), a member of the CD2 subset of Immunoglobulin superfamily, was identified as an activating receptor on NK cells. Interaction of 2B4 with its ligand CD48 or anti-2B4 mAb stimulates NK cell cytolytic function as well as production of INF-gamma. MATERIALS AND METHODS: A murine tumor model was used to study the in vivo role of 2B4. 2B4 and CD48 were activated in vivo by injecting anti-2B4 and anti-CD48 monoclonal antibodies. RESULTS: Activation of 2B4 or CD48 resulted in a five-fold reduction in tumor metastasis. IFN-gamma knockout mice had a two-fold increase in metastasis as compared to wild-type after 2B4 activation. CONCLUSION: Activation of 2B4 and CD48 reduces metastasis of B16F10 melanoma cells and this anti-tumor effect involves both cytolytic function and cytokine production.